CHAPTER Ph
100 ORGANIZATIONAL RULES
PART Ph 101 PURPOSE AND SCOPE
Ph 101.01 Purpose and Scope. The rules of this title implement the
statutory responsibilities of the
Source. #1856, eff 11-9-81; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-A, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-A,
eff 2-5-96
PART Ph 102 DEFINITIONS
Ph 102.01 Statutory Definitions Adopted. All terms used in these rules shall have the
same meaning as in RSA 318:1, RSA 318-B:1 and RSA 541-A:1.
Source. #1639, eff 11-1-80; amd by #1856, eff
11-9-81; ss by #2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff
8-1-89; ss by #6094-A, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-A,
eff 2-5-96
Ph 102.02 Other Definitions.
(a)
"Board" means the
(b)
"Evidence" means all oral or documentary material received by
the board. Evidence includes, but is not
limited to, testimony under oath or affirmation, documents, exhibits, and sworn
statements of witnesses who are unable to appear at the proceedings.
(c)
"Executive secretary" means the board's staff director, a
person with delegated authority to perform administrative and clerical
functions for the board.
(d)
"Licensed" means a person or place lawfully authorized to
engage in the practice of pharmacy under RSA 318:18 and RSA 318:37 and includes
''registered'' when used to refer to pharmacists or pharmacies.
(e)
"Order" means the whole or any part of the final decision,
whether affirmative, negative or declaratory in form, of the board in any
matter other than rulemaking, but including licensing. An order has particularized effect on each
party to the proceeding.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-A, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-A,
eff 2-5-96
PART Ph 103 AGENCY ORGANIZATION
Ph 103.01 Composition. The
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-A, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-A, eff 2-5-96, EXPIRED 8-8-10 pursuant
to RSA 541-A:17, II
New. #10117, eff 4-20-12
Ph 103.02 Officers. Annually, in September, the board members
shall elect, from among their number, a president, a vice president, a
secretary and a treasurer.
Source. #6181-A, eff 2-5-96
Ph 103.03 Address.
(a)
The board shall maintain an office at 7 Eagle Square, Concord, N.H.
03301. All correspondence with the board
shall be addressed as follows:
State of
7 Eagle Square
Concord, New
Hampshire 03301.
(b)
The telephone number of the board shall be (603) 271-2152. The fax number shall be (603) 271-2856.
Source. #6181-A, eff 2-5-96
Ph 103.04 Meetings.
(a)
The board shall meet in its office on the third Wednesday of each
month. Special meetings shall be held at
the call of the president or by any officer.
(b)
A majority of the board may take action by telephone poll or written
ballot provided that such action is ratified at a subsequent meeting of the
board.
Source. #6181-A,
eff 2-5-96
PART Ph 104 PUBLIC INFORMATION
Ph 104.01 Records. Except as exempted by law, all records of the
board may be examined by any person at the board office, during weekdays,
excluding holidays, from 8:00 a.m. to 4:00 p.m.
Source. #6181-A,
eff 2-5-96
Ph 104.02 Copies.
(a)
At the time and place identified in Ph 104.01, any person examining a
document may make a copy of that document by any means not injurious to the
document provided that the person wishing to make the copy supplies the means
of doing so in the office of the board.
In the event a person does not have a means of copying those documents,
the board shall make copies of the documents examined upon request.
(b)
The prescribed fee for copies of documents made by this board shall be a
minimum of $5.00 which includes up to 20 pages then 0.25¢ for each additional
page thereafter and shall be payable in advance by bank draft, money order,
certified check or cash.
Source. #6181-A,
eff 2-5-96
Ph 104.03 Lists of Licensees/Registrants.
(a)
Instead of the examination and copying permitted by Ph 104.01 and Ph
104.02, any person may request the board to provide that person with a complete
mailing list of the board’s
licensees/registrants. This request
shall be accompanied by the prescribed fee for each list requested and shall be
paid by check or money order.
(b)
The fees for the lists shall be:
(1) Pharmacist data file by e-mail $125.
(2) Pharmacist data file on CD-ROM $150.
(3) Pharmacist pre-printed mailing labels $200.
(4) Pharmacy Technician data file by e-mail $125.
(5) Pharmacy Technician data file on CD-ROM $150.
(6) Pharmacy Technician pre-printed mailing
labels $200.
(7) In-State Pharmacy data file by e-mail $
75.
(8) In-State Pharmacy data file on CD-ROM $100.
(9) In-State Pharmacy pre-printed mailing labels $150.
(10) Out-of-State Pharmacy data file by e-mail $ 75.
(11) Out-of-State Pharmacy data file on CD-ROM $100.
(12) Out-of-State Pharmacy pre-printed mailing
labels $150.
(13) Drug Manufacturer/Wholesaler data file by
e-mail $
75.
(14) Drug Manufacturer/Wholesaler data file on
CD-ROM $100.
(15) Drug Manufacturer/Wholesaler pre-printed
mailing labels $150.
Source. #6181-A,
eff 2-5-96; ss by #9139-A, eff
4-25-08
CHAPTER
Ph 200 RULES OF PRACTICE AND PROCEDURE
REVISION
NOTE:
Document #13882, effective 2-22-24,
repealed Part Ph 201 through Part Ph 209 in Chapter Ph 200, titled “Practice
and Procedure”, and renamed the chapter as “Rules of Practice and
Procedure”. Document #13882 also adopted
a new Part Ph 201 containing Ph 201.01 titled “Rules of Practice and Procedure”
and Ph 201.02 titled “Waiver of Administrative Rules.”
Document
#13882 replaces all prior filings affecting the rules in the former Chapter
Ph 200.
The prior filings included the following documents. Italics indicate
the rules were subject to expiration only pursuant to RSA 541-A:17, II:
#1639, eff 11-1-80
#1909, eff 1-7-82;
#2260, eff 1-5-83
#2914, eff
11-27-84
#4600, eff 8-1-89
#6094-B, INTERIM,
eff 9-21-95, EXPIRED: 1-19-96
#6181-B, eff
2-5-96, EXPIRED: 2-5-04
#8315-A, eff
3-26-05 (Ph
201-Ph 208 only)
#8315-B, eff
3-26-05, EXPIRED: 3-26-13 (Ph 209 only)
#12484, eff
2-24-18
(Ph 209 only)
#13020, EMERGENCY,
eff 4-8-20, EXPIRED 10-5-20 (Ph 210 only)
PART Ph 201 APPLICABILITY AND WAIVER OF SUBSTANTIVE RULE
Ph 201.01 Rules of Practice and Procedure. The Plc 200 rules shall govern with regards
to all procedures for:
(a)
The receipt and investigation of misconduct complaints;
(b)
The conduct of adjudicative and non-adjudicative proceedings;
(c)
Rulemaking submissions, considerations, and dispositions of rulemaking
petitions;
(d)
Public comment hearings;
(e)
Declaratory rulings;
(f)
Explanation of adopted rules;
(g)
Voluntary surrender of licenses; and
(h)
Waivers.
Source. (See Revision Note at chapter heading for Ph
200) #13882, eff 2-22-24; ss by #14196, eff 2-20-25
CHAPTER Ph
300 LICENSING OF PHARMACISTS AND
PHARMACIES
PART Ph 301 LICENSING OF PHARMACISTS BY EXAMINATION
Ph 301.01 Application.
(a)
Application form Ph A-1, revised September 2015, for licensure to
practice the profession of pharmacy in
(b)
Applicants for licensure shall submit a completed form A-1 application
for licensure and file it at the office of the board identified in Ph 103.03
along with:
(1) A copy of the candidate's birth certificate;
(2) A recent, full face photograph of the
candidate;
(3) An official final transcript sent directly
from the college to the board office; and
(4) The prescribed fee which shall be $265.
(c)
An official final transcript shall be mailed directly from the college
to the board before either NAPLEX scores or
(d)
The photograph required by Ph 301.01 (b)(2) shall be attached to the
application form in the presence of a notary public or justice of the peace.
Source. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a), (d), (e) and subparagraphs (b)(1)-(b)(10) EXPIRED:
2-5-04; amd by #8316, eff 3-26-05; (b) intro., subparagraph (b)(11), and
paragraph (c) EXPIRED: 2-1-07; paragraphs (a), (d), (e) and subparagraphs
(b)(1)-(b)(10) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 301.02 Additional Requirements. In addition to any requirements imposed by
statute, all candidates for a license to practice pharmacy in
(a)
The candidate shall be not less than 18 years of age;
(b)
The candidate shall be of good professional character, and not have been
convicted of any felony, or of a misdemeanor resulting from a violation of any
drug and/or pharmacy-related law or rule;
(c)
The candidate shall have graduated with a doctor of pharmacy degree (PharmD)
granted by a school of pharmacy, or a college of pharmacy, or a department of a
pharmacy of a university;
(d)
To meet the requirements of (c) above, the school, college or department
of pharmacy, shall be accredited by the Accreditation Council for Pharmacy
Education (ACPE) or the Canadian Council for Accreditation of Pharmacy Programs
(CCAPP).
(e) If a foreign graduate, in lieu of (c) and (d)
above, the candidate shall have graduated from a foreign college of pharmacy
other than Canada and have obtained full certification from the FPGEC
including:
(1) Passing the FPGEE with a score of at least
75; and
(2) Demonstrating proficiency in english by passing the Test Of English as a Foreign
Language Internet Based Test (TOEFL iBT).
(f)
Prior to the examination date, the candidate shall:
(1) Have completed an internship in pharmacy
which consists of:
a. At least 1500 hours, starting no earlier than
4 months prior to the third year of study in a college of pharmacy; and
b. Work
predominantly related to the practice of pharmacy including, but not limited
to:
1.
The selling of drugs and medical supplies;
2.
Interpreting, compounding, preparing and dispensing prescription orders;
3.
Preparing pharmaceutical products; and
4.
Keeping records and preparing reports required by federal and state
statutes.
(2) Have completed the internship record form Ph
A-3 revised September 2015 and submitted it to the board.
(g)
The candidate shall complete and pass the examinations described in Ph
301.03.
Source. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a)-(d) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05;
paragraphs (e)-(g) EXPIRED: 2-1-07; paragraphs (a)-(d) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 301.03 Required Examinations. The
examinations required for pharmacist licensure in
Source. #6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 301.04 Required Examination Score. To successfully complete the NAPLEX and NH
MPJE examinations required by Ph 301.03, the candidate shall, on the initial
examination or any subsequent re-examination permitted by Ph 301.05, obtain a
score of not less than 75 on each examination.
Source. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraph (a) and subparagraphs (b)(1) and (b)(3) EXPIRED: 2-5-04; amd
by #8316, eff 3-26-05; paragraph (b) and subparagraphs (b)(2) and (b)(4)
EXPIRED: 2-1-07; paragraph (a) and subparagraphs (b)(1) and (b)(3) EXPIRED:
3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 301.05)
Ph
301.05 Notice and Election of
Re-examination.
(a)
Any candidate who fails to obtain the minimum required score on either
of the 2 examinations required in Ph 301.03 may elect to retake the
examination.
(b)
All candidates shall notify the board in writing whether he/she elects
to be re-examined. The candidate for
re-examination shall register and pay for the re-take examination through the
National Association of Boards of Pharmacy online registration website
accessible at www.nabp.net.
Source. #6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 301.06)
Ph 301.06 Issuance or Denial of Original License.
(a)
If candidate timely files an application, complete in all respects,
successfully completes all examinations required by Ph 301 and demonstrates the
complete fulfillment of the requirements of these rules, RSA 318, and RSA
318-B, the board shall issue a license to practice pharmacy.
(b)
In the event a candidate for an original license to practice pharmacy in
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (formerly Ph 301.07)
PART Ph 302 LICENSING OF PHARMACISTS BY RECIPROCITY
Ph 302.01 Reciprocity.
(a)
Instead of retaking the NAPLEX examination required by Ph 301.03, a
candidate may transfer the actual score he or she attained on the NAPLEX
administered by a state other than New Hampshire, provided that:
(1) The candidate is still duly licensed and is
in good standing in that state; and
(2) All other
Source. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; subparagraphs (a)(1)-(a)(3) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05;
paragraph (a) intro. EXPIRED; 2-1-07; subparagraphs (a)(1)-(a)(3) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 302.02 Application.
(a)
The preliminary application for reciprocal licensure may be obtained
from a link provided on the NH board of pharmacy website or from the National
Association of Boards of Pharmacy,
(b)
Following verification of the applicant’s credentials by NABP the
applicant shall receive an official NABP license transfer application in the
mail.
(c)
The candidate shall file a completed NABP license transfer application
provided by the National Association of Boards of Pharmacy along with NH form
Ph A-1, revised September 2015, application for initial
licensure as a pharmacist in NH, and attach the following:
(1) A copy of the candidate's birth certificate,
or if born outside of the United States, a copy of the certificate of
naturalization or passport showing date of birth;
(2) A recent, full-face photograph of the
candidate attached to the application;
(3) An official copy of the candidate's pharmacy
college transcript mailed directly from the college to the board, or if a
foreign graduate, certification from the FPGEC; and
(4) The application fee of $265.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 302.03 Requirements. In addition to any requirements imposed by
statute, all candidates for licensure by reciprocity to practice pharmacy in
(a)
The candidate shall be not less than 18 years of age;
(b)
The candidate shall be of good professional character as evidenced by
the absence of conviction of any felony or of a misdemeanor resulting from a
violation of any drug and/or pharmacy related law or rule;
(c)
The candidate shall possess a professional pharmacy baccalaureate degree
or a doctor of pharmacy degree (PharmD) granted by a school of pharmacy, or a
college of pharmacy, or a department of pharmacy of a university accredited by
the Accreditation Council for Pharmacy Education (ACPE) or the Canadian Council
for Accreditation of Pharmacy Programs (CCAPP);
(d) A candidate who is a foreign
pharmacy graduate, other than Canadian, in lieu of (c) above, shall provide
written documentation that such candidate has:
(1) Obtained full certification from the FPGEC;
and
(2) Passed NAPLEX;
(e)
The candidate shall be licensed and in good standing in the state from
which he or she is seeking licensure transfer; and
(f)
The candidate for a reciprocal license shall complete and pass the NH
MPJE examination on the current federal and state laws and rules governing the
practice of pharmacy in the state of
Source. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; (a) intro. and subparagraphs (a)(1)-(a)(3) EXPIRED: 2-5-04; amd by
#8316, eff 3-26-05; subparagraphs (a)(4) and (a)(5) EXPIRED: 2-1-07; (a) intro.
and subparagraphs (a)(1)-(a)(3) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 302.04)
Ph 302.04 Reciprocity Application Time Limitation. Candidates who fail to complete the MPJE
examination, as required by Ph 302.03(f), within one year after the candidate's
application is received at the board office shall have their application
denied, but fees shall be retained by the board. If a candidate wishes to re-apply for
Source. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; intro. paragraph and paragraphs (a)-(d) EXPIRED: 2-5-04; amd by #8316,
eff 3-26-05; paragraphs (e)-(j) EXPIRED: 2-1-07; intro. paragraph and
paragraphs (a)-(d) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 302.06)
Ph 302.05 NH MPJE
Examination Required Scores and Fees.
(a)
To successfully complete the examination required by Ph 302.03(f), the
candidate shall, in the initial examination or any subsequent re-examination,
obtain a score of not less than 75.
(b) The candidate shall pay the current examination fee to, and as assessed by, NABP.
Source. #6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 302.06 NH MPJE
Re-Examination Notice and Election.
(a)
Any candidate who has failed to attain the minimum score on the NH MPJE
examination as required by Ph 302.05, shall notify the board in writing whether
he or she elects to be re-examined.
(b)
Any candidate for re-examination of the NH MPJE examination shall
register and pay for the re-take examination through the National Association
of Boards of Pharmacy online registration website accessible at www.nabp.net.
Source. #6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 302.07 Reciprocity License Issuance or Denial.
(a)
If a candidate timely files an application, complete in all respects and
meeting the requirements of Ph 302, and demonstrates the fulfillment of the
requirements of these rules and RSA 318 and RSA 318-B, the board shall issue a
license to practice pharmacy.
(b)
In the event a candidate for a reciprocity license to practice pharmacy
in New Hampshire fails to meet the requirements of these rules or RSA 318 and
RSA 318-B, or both, the board shall deliver to the candidate a written denial
of the application, specifying in detail each requirement which the candidate
failed to meet, and how the candidate is deficient.
Source. #6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
amd by #8572, eff 2-23-06; paragraph (a) EXPIRED: 2-1-07; paragraph (b)
EXPIRED: 2-23-14
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (formerly Ph 302.09)
PART Ph 303 PHARMACY PERMIT OPTION
Ph 303.01 Licensing the Entire Store Area.
(a)
The pharmacy shall include the prescription department and all other
retail sections of the store.
(b)
The entire pharmacy shall be equipped with a functional alarm system to
prevent entry when the pharmacy is not open to the public, according to Ph
702.04.
(c)
The prescription department shall not be closed while the balance of the
establishment remains open.
(d)
A licensed pharmacist shall be on duty at all times when the pharmacy is
open to the public.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 303.02 Licensing Only the Prescription Department.
(a)
The pharmacy shall include only the prescription department where drugs,
chemicals, medicines, prescriptions are stored, compounded and dispensed. This area shall not include the other retail
sections of the store the principle business of which is not the practice of
pharmacy.
(b)
The prescription department described in (a), above, shall be equipped
with a functional alarm system to prevent entry when the pharmacy is not open
to the public according to Ph 702.04.
(c)
The prescription department may be closed while the remainder of the
business establishment remains open to the public. During such periods, the pharmacy shall
comply with Ph 702.04.
(d) A licensed pharmacist shall be on duty at all
times when the prescription department is open to the public and during any
absences by the pharmacist, the prescription department shall be secured except
as is provided in Ph 704.01(b).
(e)
Whenever the prescription department is closed, a sign indicating that
there is no pharmacist on duty shall be conspicuously displayed in the pharmacy
area. Such sign shall be composed of
3" lettering.
(f)
Whenever the prescription department is closed, prescriptions may be
left via a mail slot which falls directly into the pharmacy area.
(g)
The prescription mail slot:
(1) Shall be constructed so as to accept only a
written or typed prescription or a notation of the prescription number for
refills;
(2) Shall be no larger than 8" X 1" and
designed so that prescriptions or notations, once deposited, cannot be
retrieved by hand or by mechanical means; and
(3) Shall be constructed so as to deliver these
prescriptions or notations directly into the prescription area for access by
the pharmacist only so that they are not visible to the general public.
(h) No prescription, new or refill, shall be left
with or accepted by pharmacy technicians as defined in RSA 318:1, XI-b or
pharmacy interns as provided in RSA 318:42, IX when the prescription department
is closed except as is provided in Ph 704.01(c).
(i)
No finished prescriptions shall be left outside of the pharmacy area
prescription department for pick‑up when the prescription department is
closed.
(j) No telephone prescriptions, new or refill
shall be accepted by pharmacy technicians or pharmacy interns when the
prescription department is closed except as is provided in Ph 704.01(c).
(k)
All drug order deliveries containing prescription drugs shall be
delivered only when the prescription department is open and/or a licensed
pharmacist is on the premises in order to secure such drug orders.
(l)
A barrier preventing access to the prescription department by the
public, shall be erected pursuant to the security requirements of Ph 702.04(c).
(m)
The pharmacist-in-charge may designate personnel, in compliance with the
provisions of Ph 702.05(b), to have keys, and a list of these individuals shall
be communicated to the board of pharmacy in writing whenever changes occur.
(n)
All prescription departments licensed under this section shall be so
equipped with a physical barrier from floor to ceiling capable of being locked
and alarmed, separate from the rest of the store, to be utilized when the
prescription department is not opened to the public.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by #8572, eff 2-23-06;
paragraphs (a)-(c), (e)-(g), (i), and (k)-(n) EXPIRED: 3-26-13; paragraphs (d),
(h), and (j) EXPIRED: 2-23-14
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
PART Ph 304 PHARMACY PERMIT APPLICATION
Ph 304.01 Obtaining and Filing a Permit Application.
(a)
Application Ph B-1 revised September 2015 for a permit to operate a
pharmacy in New Hampshire may be obtained from the board or board website, and
shall be filed at the board office, identified in Ph 103.03;
(b)
Form Ph B-1 shall be used
for:
(1) Applying for a permit to operate a new
pharmacy within the State of
(2) Changing the location of a currently licensed
(3) Changing the ownership of a currently
licensed
(4) Changing the pharmacist-in-charge of a
currently licensed
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 304.02 Application Contents.
(a)
The applicant for a permit to operate a pharmacy in
(b)
The applicant shall also submit scale drawings of the pharmacy,
detailing usage of all space.
(c) The applicant shall supplement the
application with any certificates, affidavits, plans, documents, or other
information sufficient to show full compliance with all of the requirements of
Ph 304.
(d)
The applicant shall submit a certificate from the secretary of state
attesting to the documents creating the corporate person and any amendment(s)
thereof to the certificate of incorporation, or authorizing it to do business
in the state of
(e)
The application shall be filed with the prescribed fee of $250.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a)-(d) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05;
paragraph (e) EXPIRED: 2-1-07; paragraphs (a)-(d) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
PART Ph 305 PHARMACY PERMIT PROCEDURE
Ph 305.01 Pharmacy Permit Conference.
(a)
In addition to all requirements set forth in the statutes and elsewhere
in this chapter, each applicant applying for a permit to operate a pharmacy in
(b)
If the owner is not the pharmacist-in-charge, then the owner or an
officer of the corporation, or the district manager, as well as the anticipated
pharmacist-in-charge shall appear before the board.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 305.02 Site Inspection for Pharmacy Permit.
(a)
Following the applicant's conference, the proposed site shall be
inspected by one or more board members or compliance inspectors to determine if
the premises are secure and suitable, as set forth in the NH pharmacy
application information according to the provisions of Ph 702, for the
operation of a pharmacy and that the required professional library material,
according to Ph 702.07 (c) & (d), is available.
(b)
Within the 60 day period after the issuance of the temporary permit as
required by Ph 305.03, an inspector or a board member or both shall inspect the
pharmacy. The full operation of the
pharmacy shall be examined for compliance with federal and state statutes and
rules governing the practice of pharmacy to ensure public protection.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 305.03 Issuance and Denial of Pharmacy Permit.
(a) Applicants shall file a completed
application at least 30 days before consideration will be given for a temporary
permit.
(b)
Providing that, the premises are suitable, according to Ph 305.02 (a),
for the operation of a pharmacy and the applicant has met all other
requirements of these rules and RSA 318, the applicant shall be granted a
temporary permit which shall expire in 60 days.
The temporary permit shall authorize the operation of a pharmacy only in
the location and only under the name specified in the permit and shall
authorize the pharmacist-in-charge to buy, possess and dispense prescription
drugs, chemicals and pharmaceuticals.
(c)
After consideration of the application and the report of the primary
site inspection, the board shall notify the applicant in writing of all
deficiencies in the application which, in the absence of correction, shall
result in the denial of the application.
The applicant shall, within 20 days of the date of the notice of
deficiency, deliver to the board documents evidencing the correction of those
deficiencies. In the absence of
a timely filing of
documentation, the application shall, without further action or notice by the
board, be denied effective as of the expiration of 20 days after the date of
the notification of deficiency.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
PART Ph 306 PHARMACY PERMITS - CHANGES IN SUPPORTING DATA
Ph 306.01 Pharmacy Ownership Transfer. A transfer of ownership shall include any of
the following:
(a)
The sale of the pharmacy;
(b)
The addition or deletion of one or more partners in a partnership;
(c)
The death of a singular owner; or
(d) In a publicly traded, multi-tiered
corporation, a change in the corporate ownership of the majority or controlling
interest of the lowest tier of the corporate structure doing business as a
pharmacy in the State of New Hampshire.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by #8572, eff 2-23-06;
intro. paragraph and paragraphs (a)-(c) EXPIRED: 3-26-13; paragraph (d)
EXPIRED: 2-23-14
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 306.02 Reporting Changes. The person to whom a permit to operate a
pharmacy in New Hampshire has been issued shall, within 15 days of that
person's discovery of a change in any of the data contained in the application
for an original or renewal permit, report that change to the board in writing.
An original new permit application, form Ph B-1 revised September 2015 shall be
completed and filed in addition to the written notice when the name, location,
ownership, licensed area or pharmacist in charge of the pharmacy are
changed.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 306.03 Change in Pharmacy Name or Location -
Prohibited. No person shall operate
a pharmacy under a name, or at a location, different from the name and location
contained in the permit issued pursuant to Ph 304.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 306.04 Renovations. Plans for any renovation at any time
after an original permit is issued shall be filed with the board for review and
approval before proceeding with such changes.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 306.05 Special Permit Provisions for Sudden
Termination of Pharmacist-In-Charge (PIC).
Existing pharmacy permit holders who have a sudden loss of the
pharmacist-in-charge (PIC), shall be issued a special pharmacy permit valid for
60 days while a new PIC is identified and appears before the board according to
Ph 305.01.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
PART Ph 307 RENEWAL AND REPLACEMENT PHARMACY PERMITS
Ph 307.01 Renewal Permits Required. The person to whom a permit to operate a
pharmacy in
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 307.02 Renewal Application Where Obtained and
Filed. Applications for the renewal
of a permit to operate a pharmacy in
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 307.03 Renewal Application Contents and When
Filed.
(a)
Applications for renewal of a permit to operate a pharmacy in
(b) Renewal applications as required pursuant to
Ph 307.01 shall be submitted to the board office identified in Ph 103.03 no
later than the 15th day of December of each year.
Source. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraph (b) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; paragraph (a)
EXPIRED: 2-1-07; paragraph (b) EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, , EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 307.04 Renewal Application Deficiencies. The board shall notify the applicant in
writing as to how the application for renewal is deficient. The applicant may, within 10 days after the
date of the notice of deficiency, correct the deficiency or the renewal shall
be denied.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 307.05 Issuance
or Denial of Renewal Permit.
(a)
If an applicant shall timely file an application, complete in all
respects, and shall demonstrate the fulfillment of all the requirements of
these rules and RSA 318, the board shall issue a renewal permit.
(b)
An application which continues to fail to meet the requirements
of these rules and RSA 318 shall be denied.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 307.06 Replacement Permit Application and
Contents.
(a)
The holder of a current permit to operate a pharmacy in
(b)
The request for a replacement permit shall:
(1) Be in writing;
(2) Contain the number of the current permit held
by the applicant, if known;
(3) Be accompanied by the remains, if any, of the
permit for which a replacement is sought;
(4) Be accompanied by the prescribed fee of $25;
and
(5) Be filed at the board office.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
PART Ph 308 REVOCATION AND SUSPENSION OF A PHARMACY
PERMIT
Ph 308.01 Grounds for Revocation or Suspension. The board may revoke or suspend a permit to
operate a pharmacy for grounds which include but are not limited to:
(a)
Misconduct as described in RSA 318:29, II; and
(b)
Violations of the provisions of RSA 318:29, V.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16
Ph 308.02 Effect of Revocation.
(a)
The revocation of a pharmacy permit shall permanently withdraw the
authority to operate a pharmacy in
(b)
A subsequent permit may be obtained only by:
(1) Complying with all of the requirements of RSA
318 and these rules regarding the original licensing of pharmacies;
(2) Paying all penalties assessed in connection
with the cause for revocation; and
(3) By
demonstrating that the cause for revocation does not exist at the time of the
subsequent application.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 308.01)
Ph 308.03 Effect of Suspension.
(a)
The suspension of a pharmacy permit shall temporarily withdraw the
authority to operate a pharmacy in
(b)
The authority to operate a pharmacy in
(1) Complying with all of the requirements
specified in the order of suspension;
(2) Complying with all of the requirements of RSA
318 and these rules regarding the renewal of a pharmacy permit; and
(3) Paying all penalties assessed in connection
with the cause for suspension.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 308.02)
Ph 308.04 Voluntary Surrender When Permitted.
(a)
Any person holding a pharmacy permit may voluntarily return that permit
to the board.
(b)
The return of such permit shall be accompanied by the licensee's signed,
written statement as to why the permit is being voluntarily returned to the
board.
(c)
The voluntary surrender of a permit to operate a pharmacy in
(d)
Voluntary surrender of a permit to operate a pharmacy in New Hampshire
shall not be permitted if there exists, at the time the permit is presented to
the board, any cause for involuntary revocation or suspension of the licensee's
permit to operate a pharmacy, unless the licensee presenting the permit shall
state in writing that the voluntarily surrendered permit is in lieu of
proceedings for the involuntary revocation or suspension of the permit to
operate a pharmacy in New Hampshire.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 308.03)
Ph 308.05 Hearing. Except as authorized by statute or these
rules, a permittee to operate a pharmacy in New Hampshire shall not be
disciplined except after notice and opportunity for hearing provided by Ph 200.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16 (from Ph 308.04)
PART Ph 309 STANDARDS
OF PRACTICE FOR MANUFACTURERS, WHOLESALERS AND DISTRIBUTORS – Moved to Ph 1000
Ph 309.01 – Ph 309.14
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10702, INTERIM, eff 10-23-14, EXPIRED:
4-21-15
New. #11031, eff 1-29-16; renumbered by #12007
(see Ph 1000)
CHAPTER Ph
400 CONTINUED STATUS
PART Ph 401 RENEWAL AND REPLACEMENT LICENSES
Ph
401.01 Obtaining and Filing Renewal
Applications. Applicants for renewal
of a license to practice pharmacy shall submit, by December 15th of
every even-numbered year, a Renewal License Form renewal form Ph A-2. The application may be obtained from the
board office. Alternatively, applicants
may file the renewal application online at https://nhlicenses.nh.gov/eGov/Login.aspx
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15;
ss by #13117, eff 10-15-20
Ph
401.02 Renewal Application Contents
and Filing Deadline.
(a) Applications for renewal of a license to
practice pharmacy in New Hampshire under RSA 318 shall be completed and filed
biennially by December 15th of each even-numbered year.
(b) With the exception of authorized immunizing
pharmacists per the provisions of Ph 1300, which shall have the combined renewal fee as noted below in (c), the
application and the prescribed fee of $250
shall be filed with the board no later than December 15th of
each even-numbered year. Each licensee shall complete and file his or her
application for license renewal prior to this date.
(c) The biennial renewal fee for pharmacists who are authorized immunizing pharmacists
shall be $270, which includes a fee for the immunization endorsement on their
pharmacist license.
(d) Per the provisions of RSA 318:29-a, VI(b),
$30 of each biennial pharmacist renewal fee noted in sections (b) and (c) above shall be used to fund the
impaired pharmacist program.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a) and (b) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; amd
by #9139-B, eff 4-25-08; paragraphs (a) and (b) EXPIRED: 3-26-13; ss by #10842,
eff 6-3-15; ss by #13117, eff 10-15-20
Ph 401.03 Renewal Application Deficiencies. Within 5 days of receipt at the board office,
the board shall notify the applicant in writing if the renewal application is
deficient. The applicant may then
correct the deficiency or file with the board a written request for a hearing
before the board.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 401.04 Renewal License Issuance and Denial.
(a) If an applicant timely files an application,
complete in all respects, and demonstrates the fulfillment of all the
requirements of these rules and RSA 318, the board shall issue a renewal
license to practice pharmacy.
(b) Applicants shall register with the New
Hampshire Prescription Drug Monitoring Program pursuant to the requirements
articulated in RSA 318-B:33, II and Ph 1503.01 (a).
(c) An application failing to meet the
requirements of these rules or RSA 318, or both, shall, after the notice and
opportunity for hearing, be denied.
(d) Applicants who fail to register for the New
Hampshire Prescription Drug Monitoring Program pursuant to RSA 318-B:33, II and
Ph 1503.01 (a), shall, after the notice and opportunity for hearing, be denied.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 401.05 Duplicate/Replacement Original Certificate
of Licensure or Renewal License - Issuance.
(a)
If seeking a duplicate or replacement for an original certificate of
licensure the applicant shall:
(1) Submit a written request, signed by the
pharmacist, to the board for replacement; and
(2) Provide payment of the prescribed fee which
shall be $50.
(b)
If seeking a duplicate or replacement
for an annual renewal license the applicant shall:
(1) Submit a written request, signed by the
pharmacist, to the board for a duplicate or replacement; and
(2) No fee shall be assessed for a duplicate or
replacement renewal license.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 401.06 Reinstatement. A pharmacist whose license to practice
pharmacy in this state has been suspended, revoked, voluntarily surrendered, or
allowed to lapse shall be subject to the following requirements for
reinstatement:
(a)
File a reinstatement application provided by the board which shall
include the following:
(1) Name, address, and telephone number of the
applicant;
(2) Date
of birth; and
(3) Current employment information.
(b)
Pay the reinstatement fee of $200 if suspended, revoked, voluntarily
surrendered, or allowed to lapse for longer than 30 days;
(c)
Submit certificates of attendance or participation in continuing pharmaceutical
education courses or programs, described in Ph 403, for a minimum of 30 hours,
of which at least 10 hours shall be earned in a live setting;
(d)
All such continuing education shall have been earned in the period 24
months immediately preceding the date of application for reinstatement;
(e)
If the pharmacist has not held a license to practice pharmacy in this
state for a period of 2 years or more, the applicant shall provide, in addition
to the document required in (a), (b), and (c) above:
(1) Notarized affidavit(s) documenting the
pharmacist's pharmacy experience during the 2 years immediately preceding the
date of his or her application for reinstatement; and
(2) Proof of status of licensure in all states
that the pharmacist has been licensed in; and
(f) If the pharmacist has not held a license to
practice pharmacy in this state for a period of 5 years or more and has not
practiced pharmacy in any other state, the board shall require the completion
of a period of pharmacy practice internship no less than 160 hours in duration
prior to reinstatement in addition to the requirements in (a) through (d)
above.
Source. #2442, eff 9-1-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd
by #6933, eff 2-1-99; intro. paragraph and paragraphs (a)-(d) and (f)-(g)
EXPIRED:
2-5-04; amd by #8316, eff 3-26-05; paragraph (e) EXPIRED:
2-1-07; intro. paragraph and paragraphs (a)-(d) and (f)-(g) EXPIRED: 3-26-13
New. #10812, eff 4-18-15; ss by #13514, eff
2-19-23
Ph 401.07 Gold Certificates.
(a)
The board of pharmacy shall issue a gold certificate to any pharmacist
who has been regularly licensed as a pharmacist in
(b)
Gold certificates shall be distinctive in coloration and text from other
pharmacist licenses issued by the board, and shall be designed to appropriately
recognize each recipient pharmacist for his/her half‑century of
professional practice.
(c)
A gold certificate shall be a one-time issuance of honorary nature and
confer no right to practice pharmacy upon the recipient.
(d)
The awarding of gold certificates shall be made by the board of pharmacy
without charge to the recipient.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
PART Ph 402 DISCIPLINARY MATTERS
Ph 402.01 Effect of Revocation.
(a)
The revocation of a pharmacist license shall permanently withdraw the
authority to practice pharmacy in
(b)
A subsequent license may be obtained only by:
(1) Complying with all of the requirements of RSA
318 and these rules regarding the original licensing of pharmacists;
(2) Paying all penalties assessed in connection
with the cause for revocation; and
(3) Demonstrating that the cause for revocation
does not exist at the time of the subsequent application.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 402.02 Effect of Suspension.
(a)
The suspension of a pharmacist license shall temporarily withdraw the
authority to practice pharmacy in
(b)
The authority to practice pharmacy in
(1) Complying with all of the requirements
specified in the order of suspension;
(2) Complying with all of the requirements of RSA
318 and these rules regarding the renewal of a license to practice pharmacy in
New Hampshire; and
(3) Paying all penalties assessed in connection
with the cause for suspension.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 402.03 Voluntary Surrender of License.
(a)
Any person holding a pharmacist license may voluntarily surrender that
license by returning it to the board accompanied by a signed letter stating
that the pharmacist intends to permanently surrender his or her license.
(b)
The surrender shall be effective upon acceptance by the board and shall immediately preclude the
pharmacist from practicing pharmacy in
(c) A voluntary license surrender,
standing alone, shall not prevent the pharmacist from subsequently reapplying
for a license.
(d)
The voluntary surrender of a license shall have no effect upon the
board's authority to:
(1) Investigate violations of the pharmacy laws
or the rules of the board by a person licensed at the time the alleged
violation occurred; or
(2) Impose disciplinary sanctions based on past
conduct which could affect the ability of the former licensee to reapply for a
license at a later date.
(e)
A voluntary license surrender during the pendency of a disciplinary
proceeding shall be recorded in the board's files as "surrendered during
disciplinary proceeding."
(f)
Nothing in this section shall prohibit the board and a licensee from
entering into a settlement agreement or a consent decree relative to any
alleged violation of the pharmacy laws or the rules of the board.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 402.04 Hearing. Except as authorized by statute or these
rules, a licensee shall not be disciplined except after notice and opportunity
for hearing.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
PART Ph 403 CONTINUING EDUCATION REQUIREMENTS
Ph 403.01 Definitions.
(a)
"Accredited programs/courses" means continuing education
sponsored by providers which are approved by the American Council on
Pharmaceutical Education (ACPE) or the Canadian Council on Continuing Education
in Pharmacy (CCCEP).
(b)
“AMA category I programs” means all programs accepted by the American
Medical Association in category I.
(c)
"Board approved programs/courses" means continuing education
which has been reviewed and recommended by the continuing education advisory
council and approved by the board of pharmacy or continuing education programs
approved by a Canadian provincial or territorial pharmacy licensing authority.
(d)
“Certificate of accredited/approved CEU's” means a document, issued to a
particular pharmacist by an accredited or approved provider certifying that the
pharmacist has satisfactorily completed a specified number of CEU's. Such certificates include a unique program
identification number issued by the accrediting/approving provider.
(e)
“Continuing education” means accredited or approved post‑licensure
pharmacy education designed to maintain professional competence in the practice
of pharmacy, improve professional skills, and preserve pharmaceutical standards
for the purpose of protecting the health and welfare of the citizens in the
state of
(f)
“Continuing education advisory council (CEAC)” means a group of
individuals appointed by the board of pharmacy to serve in an advisory capacity
on continuing education.
(g)
“Continuing education unit (CEU)” means 10 contact hours of
participation in accredited or board approved continuing education
courses/programs.
(h) “In-state approved provider” means
an individual, institution, organization, association, corporation or agency
located in the state of New Hampshire in no manner affiliated with any
manufacturer or distributor of supplies or services used in the practice of
pharmacy, who is approved by the board of pharmacy to provide continuing
pharmacy education according to Ph 403.12.
Source. #1867, eff 11-22-81; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff
2-5-96; amd by #6933, eff 2-1-99; paragraphs (c)-(h) EXPIRED: 2-5-04; amd by
#8316, eff 3-26-05; paragraphs (a) and (b) EXPIRED: 2-1-07; paragraphs (c)-(h)
EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.02 Renewal Requirements.
(a)
The board shall not issue licensure renewals unless the pharmacist
indicates on the renewal application, and under penalty of unsworn
falsification, that he or she has completed the minimum required hours of accredited
or approved continuing pharmaceutical education courses or programs according
to Ph 403.02(d). An incomplete renewal
application shall not be processed by the board.
(b)
Continuing education shall be required of all licensed, active or
inactive pharmacists who apply for license renewal.
(c)
Pharmacists submitting applications for their first biennial licensure
renewal shall be exempt from the continuing education requirements.
(d) All pharmacists licensed in New Hampshire
shall acquire a total of 30 hours (3.0 CEUs) during the 24 months immediately
preceding the license renewal date of January 1st. At least 10 hours (1.0 CEUs) of the total required
hours shall be earned in a live setting.
(e) Continuing education credits shall
not be recognized for any repeat program attended or completed. Repeat programs shall be identified as any
program, live or correspondence, which carries the same ACPE, CME, or any board
program identification number.
(f)
The pharmacist shall retain all certificates and other documented
evidence of participation in an approved or accredited continuing education
program or course for a period of at least 3 years. Such documentation shall be made available to
the board for random audit or verification purposes.
(g)
Not less than 10% of the registrants shall be randomly selected by the
board after October 1 of every even numbered year for determinations of
compliance with Ph 403.02.
Source. #1867, eff 11-22-81: ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a)-(f) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05;
paragraph (g) EXPIRED: 2-1-07; paragraphs (a)-(f) EXPIRED: 3-26-13
New. #10812, eff 4-18-15; ss by #13117, eff
10-15-20
Ph 403.03 Excess CEU's. Excess CEU's earned in one licensure period
shall not be carried forward into the new licensure period.
Source. #1867, eff 11-22-81: ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15; ss by #13117, eff
10-15-20
Ph 403.04 CEU's from Other States. The board of pharmacy shall accept comparable
continuing education units which have been approved by other boards of pharmacy
provided they meet or exceed the requirements as set forth in Ph 403.
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.05 Credit for Instructors of Continuing
Education.
(a)
Any pharmacist, whose primary responsibility is not the education of
health professionals, who leads, instructs or lectures to groups of nurses,
physicians, pharmacists or others on pharmacy related topics in organized
continuing education or in-service programs, shall be granted continuing
education credit for such time expended during actual presentation.
(b)
Any pharmacist whose primary responsibility is the education of health
professionals shall be granted continuing education credit only for time
expended in leading, instructing, or lecturing to groups of physicians,
pharmacists, nurses or others on pharmacy-related topics outside his/her formal
course responsibilities in a learning institution.
(c)
Credit for presentation of in-service training programs or other
lectures shall be granted only once for any given program or lecture.
(d)
A maximum of 4 hours in this category may be applied toward fulfilling
the total continuing education yearly requirements. However, these hours shall not be considered
in fulfilling the live requirements as set forth in Ph 403.02(d).
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.06 Postgraduate Pharmacy Curricula.
(a)
A pharmacist who matriculates in a postgraduate pharmacy curriculum or
post graduate pharmacy program shall be awarded CEU's for satisfactory
completion of each course within said curriculum or program.
(b)
The course work for which CEU credit is provided pursuant to (a) above,
shall provide instruction in one or more of the following areas of study:
(1) Pharmacy;
(2) Pharmaceutical calculations;
(3) Pharmaceutical chemistry;
(4) Pharmacology;
(5) Therapeutics;
(6) Pharmacy management;
(7) Pharmaceutical jurisprudence; or
(8) Other course work related to the
pharmaceutical sciences.
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.07 Audio/Visual Continuing Education.
(a)
Continuing education credit may be claimed for the completion of home
study audio and/or video cassette tape programs/courses, provided that such
programs require the completion of a written exam by the pharmacist to be
scored by the provider of such programs.
(b)
Audio/visual continuing education programs, including satellite
transmissions, which provide for group discussion and include a facilitator
shall, be allowed as live programming.
(c) Webinars that are ACPE approved and contain an
“L” in the program approval number shall be allowed as live programming.
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.08 Waiver. The board shall waive some or all of the
continuing education requirements, for a period not to exceed one calendar
year, for such hardships as illness or incapacity. Written request for waiver shall be submitted
to the board for consideration.
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.09 Military Personnel. Military personnel or spouses shall not be
exempt from the continuing education requirements, because correspondence
programs/courses are available, but shall be exempt from the live requirement
if assignment is in a foreign country.
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.10 Reinstatement. Any pharmacist desiring reinstatement of
licensure shall show evidence of completion of at least 1.5 CEU's, according to
Ph 403.02(d) and earned in the 12 months immediately preceding the date of
application for reinstatement.
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.11 Penalty. Any pharmacist who alters, forges, or
intentionally falsifies, or causes to be altered, forged, or falsified any
information, documents, or records required to be kept or submitted by this
rule shall be subject to disciplinary action under RSA 318:29, II. Falsification of records shall constitute
misconduct.
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.12 In-State Approved Providers of Continuing
Pharmacy Education.
(a)
An individual, institution, organization, association, corporation or
agency located in the state of
(b)
Approval of in-state providers shall be valid for a period of 2 years
from date of approval after which time re-application shall be necessary.
(c)
In-state providers who desire to become approved by the board shall
provide their educational qualifications and an example of a program to the
CEAC committee for review.
(d)
In state providers shall
comply with the following:
(1) The provider shall designate a responsible
person for the administration of the continuing pharmacy education program and
liaison with the CEAC and the board;
(2) Providers shall award continuing pharmacy
education credit to successful participants in terms of CEU's;
(3) The provider shall maintain a list of
successful participants for each program provided for a period of not less than
3 years;
(4) The list required by (3) above shall be made
available to the CEAC and the board on request;
(5) The provider shall award to each successful
participant a certificate containing at least the following information:
a. The name of the provider;
b. The completion date of the continuing
education program;
c. The name of the participant;
d. The title of the program;
e. The number of CEU's the program has been
assigned; and
f. The board of pharmacy program identification
number.
(6) All programs shall be referenced as
"live" or "correspondence" in nature;
(7) Providers shall present their participants
with a statement of goals and objectives prior to each continuing pharmacy
education program and involve their participants in identifying their own
educational needs;
(8) Providers shall develop and employ evaluation
techniques that will assess the effectiveness of the continuing pharmacy
education offerings and the level of fulfillment of the stated objectives with
the goal of continual improvements;
(9) Providers shall utilize an evaluation
mechanism for the purpose of allowing each participant to assess his/her
achievement of personal objectives; and
(10) Providers shall assign an identification
number to every program presented according to the numbering system designated
by the board of pharmacy.
(e)
Continuing education programs presented by in-state approved providers
shall not have to be submitted to the CEAC for review and
approval by the board.
(f)
In-state approved providers of continuing pharmacy education shall
publicize programs and/or coursework by referencing endorsement by the board
only as follows: "This program is
approved by the New Hampshire Board of Pharmacy for CEU's of continuing pharmacy
education". Programs shall also be
referenced as "live" or "correspondence" in nature.
(g)
Board approval of in-state provider shall be revoked following notice
and opportunity to be heard upon a finding that the provider has engaged in
fraud or dishonesty or is no longer in compliance with one or more of the
criteria of (d) above.
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 403.13 Continuing Education Advisory Council
Membership.
(a)
The advisory council shall consist of not less than 6, nor more than 10
members, at least one of whom shall be a member of the board.
(b)
The term of appointment shall be for 3 years and shall be served until
the expiration date or until a successor has been named. Should a vacancy occur, a successor shall be
appointed to serve the unexpired term.
(c)
The advisory council shall submit all recommendations to the board for
its implementation and/or approval.
(d)
It shall be the duty of the advisory council to:
(1) Elect from its membership a chairman and a
secretary annually;
(2) Recommend to the board the standards and
specifications required of programs/courses which might be acceptable for board
approval in fulfilling continuing education requirements;
(3) Recommend programs which meet the standards
and specifications adopted;
(4) Recommend the
number of CEU's granted for the satisfactory completion of approved programs;
and
(5) Provide such other assistance to the board
necessary in the implementation and maintenance of the continuing education
licensure renewal prerequisite.
(e)
The advisory council shall meet a sufficient number of times annually to
properly perform its functions.
(f)
The advisory council quorum shall be equal to the majority of the
council membership.
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
PART Ph 404
STANDARDS FOR COMPOUNDING AND DISPENSING STERILE AND NON-STERILE PHARMACEUTICALS
Ph 404.01 Purpose and Scope.
(a) The purpose of
this part is to provide all compounders with guidance on applying good
compounding practices for the preparation of non-sterile and sterile compounded
formulations for dispensing and/or administration to humans and animals.
Compounding is an integral part of pharmacy practice and is essential to the
provision of healthcare.
(b) The board shall require all compounders
engaging in compounding in all situations to adhere to and comply with the
current edition of the United States Pharmacopeia including but not limited to
Chapters 795 (USP 795) and 797 (USP 797), following those guidelines that apply
to their practice setting. These chapters shall be reviewed in full and
followed by compounders prior to non-sterile or sterile pharmaceutical
compounding. These regulations shall apply to non-sterile and sterile
compounding of medications.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.02 Definitions.
(a)
“Active pharmaceutical ingredients” means chemicals, substances, or
other components of articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of diseases in humans or animals or for
use as nutritional supplements.
(b)
“Added substances” means the ingredients necessary to prepare the drug
product but are not intended or expected to cause human pharmacological
response if administered alone in the amount or concentration contained in a
single doses of the compounded preparation. The term “added substances” includes the terms “inactive ingredients”,
“excipients”, and “pharmaceutical ingredients.”
(c)
“Ante-area” means:
(1) An ISO Class 8 or better area where personnel
perform hand hygiene and garbing procedures, staging of components, order
enter, CSP labeling, and other high-particulate-generating activities are
performed;
(2) A transition area that:
a. Provides assurance that pressure
relationships are constantly maintained so that air flows from clean to dirty
areas; and
b. Reduces the
need for the heating, ventilating, and air-conditioning (HVAC) control system
to respond to large disturbances.
(d)
“Aseptic processing” means a mode of processing pharmaceutical and
medical products that involves the separate sterilization of the product and of
the package containers, closures or packaging material for medical devices and
the transfer of the product into the container and its closure under at least
ISO Class 5 conditions.
(e)
“Beyond-use date (BUD)” is
the date after which a compounded preparation should not to be used; determined
from the date the preparation is compounded.
(f)
“Biological Safety Cabinet (BSC)” means a ventilated cabinet for CSPs,
personnel, product, and environmental protection having an open front with
inward airflow for personnel protection, downward high-efficiency particulate
air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered
exhausted air for environmental protection.
(g)
“Buffer area” means an area where the primary engineering control (PEC)
is physically located.
(h)
“Clean room” means a room in which the concentration of airborne
particles is controlled to meet a specified airborne particulate cleanliness
class. Microorganisms in the environment are monitored so that a microbial
level for air, surface, and personnel gear are not exceeded for a specified
cleanliness class.
(i)
“Component” means any ingredient used in the compounding of a drug
preparation, including any active ingredient or added substance that is used in
its preparation.
(j)
“Compounder” means a licensed professional authorized by the appropriate
jurisdiction to perform compounding pursuant to a prescription or medication
order by a licensed prescriber.
(k)
“Compounding” means the preparation, mixing, assembling, altering,
packaging, and labeling of a drug, drug-delivery device, or device in
accordance with a licensed practitioner's order, or initiative based on the
practitioner/patient/pharmacist/compounder relationship in the course of
professional practice, and includes the following:
(1) Preparation of drug dosage forms for both
human and animal patients;
(2) Preparation of drugs or devices in
anticipation of prescription drug orders based on routine, regularly observed
prescribing patterns;
(3) Reconstitution or manipulation of commercial
products that may require the addition of one or more ingredients;
(4) Preparation of drugs or devices for the
purposes of, or as an incident to research clinical or academic teaching, or
chemical analysis; and
(5) Preparation of drugs and devices on the order
of a practitioner, which may be sold to the practitioner for use in his or her
office to administer to a specific patient, in limited quantities, but not for
resale.
(l) “Compounding Aseptic Containment
Isolator (CACI)” means a compounding aseptic isolator (CAI) designed to provide
worker protection from exposure to undesirable levels of airborne drug
throughout the compounding and material transfer processes and to provide an
aseptic environment for compounding sterile preparations.
(m) “Compounding Aseptic Isolator
(CAI)” means a form of isolator specifically designed for compounding
pharmaceutical ingredients or preparations. It is designed to maintain an
aseptic compounding environment within the isolator throughout the compounding
and material transfer processes.
(n)
“Critical area” means an ISO Class 5 environment.
(o)
“Critical site” means a location that includes any component or fluid
pathway surfaces such as vial septa, injection ports, beakers or openings such
as opened ampules or needle hubs exposed and at risk of direct contact with air
including ambient room or HEPA filtered, moisture such as oral and mucosal
secretions, or touch contamination. Risk
of microbial particulate contamination of the critical site increases with the
size of the openings and exposure time.
(p)
“Direct Compounding Area (DCA)” means an area within the ISO Class 5
primary engineering control (PEC) where critical sites are exposed to
unidirectional HEPA-filtered air, also known as first air.
(q)
“Disinfectant” means an agent that frees from infection, usually a
chemical agent but sometimes a physical one, and that destroys disease-causing
pathogens or other harmful microorganisms but might not kill bacterial and
fungal spores. It refers to substances applied to inanimate objects.
(r)
“First air” means the air exiting the HEPA filter in a unidirectional
air stream that is essentially particle free.
(s)
“Hazardous drugs” means any drug which in studies of animals or humans
have been classified as carcinogenic, toxic to development or reproduction, or
toxic to organs.
(t)
“Labeling” means a term that designates all labels and other written,
printed, or graphic matter on an immediate container of an article or
preparation or on, or in, any package or wrapper in which it is enclosed,
except any outer shipping container. The
term “label” designates that part of the labeling on the immediate container.
(u) “Limited quantities” means a batch
with 50 or less dosage units provided to a hospital or practitioner to
administer to their own patient.
(v)
“Manufacturing” means the production, preparation, propagation,
conversion or processing of a drug or device, either directly or indirectly, by
large volume extraction from substances of natural origin, or independently by
means of chemical or biological synthesis, and includes any packaging or
repackaging of a substance or labeling or relabeling of its container, and the
promotion and marketing of such drugs and devices for resale.
(w)
“Media-fill test” means a test used to qualify aseptic technique of
compounding personnel or processes and to ensure that the processes used are
able to produce sterile product without microbial contamination. During this test, a microbiological growth
medium such as Soybean–Casein Digest Medium is substituted for the actual drug
product to simulate admixture compounding.
(x)
“Memorandum of understanding” means a document specific to the
preparation(s) provided to a practitioner by a compounder outlining the
distinct responsibilities of the compounder and practitioner.
(y)
“Multiple-dose container” means a multiple-unit container for articles
or preparations intended for parenteral administration only and usually
containing antimicrobial preservatives.
(z)
“Negative pressure room” means a room that is at a lower pressure than
the adjacent spaces and, therefore, the net flow of air is into the room.
(aa) “Pharmacy bulk package” means a
container of a sterile preparation for parenteral use that contains many single
doses. The contents are intended for use
in a pharmacy admixture program and are restricted to the preparation of
admixtures for infusion or, through a sterile transfer device, for the filling
of empty sterile syringes.
(ab)
“Positive pressure room” means a room that is at a higher pressure than
the adjacent spaces and, therefore, the net airflow is out of the room.
(ac)
“Preparation” means a compounded drug dosage form or dietary supplement
or a device to which a compounder has introduced a drug.
(ad) “Primary Engineering Control
(PEC)” means a device or room that provides an ISO Class 5 environment for the
exposure of critical sites when compounding CSPs. Such devices include, but are not limited to,
laminar airflow workbenches (LAFWs), BSCs, CAIs, and CACIs.
(ae)
“Product” means a commercially manufactured sterile drug or nutrient
that has been evaluated for safety and efficacy by the FDA.f
(af) “Segregated compounding area” means a
designated space, either a demarcated area or room, that is restricted to
preparing low-risk level CSPs with 12-hour or less BUD. This area shall contain a device that provides
unidirectional airflow of ISO Class 5 air quality for preparation of CSPs and
shall be oid of activities and materials that are
extraneous to sterile compounding.
(ag)
“Single-dose container” means a single-unit container for articles or
preparations intended for parenteral administration only. It is intended for a single use. A single-dose container is labeled as such.
Examples of single-dose containers include prefilled syringes, cartridges,
fusion-sealed containers, and closure-sealed containers when so labeled.
(ah)
“Sterilization by Filtration” means passage of a fluid or solution
through a sterilizing grade membrane to produce a sterile effluent.
(ai) “Sterilizing grade members” means that
membranes that are documented to retain 100% of a culture of 107 microorganisms
of a strain of Brevundimonas (Psuedomonas)
diminuta per square centimeter of membrane surface
under a pressure of not less than 30 psi or
2.0 (bar). Such filter membranes are
nominally at 0.22-um or 0.2-um nominal pore size, depending on the
manufacturer’s practice.
(aj) “Terminal
Sterilization” means the application of a lethal process, such as steam under
pressure or autoclaving, to sealed containers for the purpose of achieving a
predetermined sterility assurance level of usually less than 10-6, or a
probability of less than one in one million of a non-sterile unit.
(ak) “Unidirectional
flow” means the airflow moving in a single direction in a robust and uniform
manner and at a sufficient speed to reproducibly sweep particles away from the
critical processing or testing area.
(al) “United States Pharmacopia”
means a legally recognized compendium of standards for drugs.
(am) “Vehicle” means a component for internal and
external use that is used as a carrier for diluent in which liquids, semisolids
or solids are dissolved or suspended.
Examples include, but are not limited to, water, syrups, elixirs,
oleaginous liquids, solid and semisolid carriers and proprietary products.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.03 Non-Sterile Pharmaceutical Compounding.
(a) Compliance with USP 795 and all applicable
USP chapters related to non-sterile compounding shall be followed.
(b) There are 3 general categories of non-sterile
compounding described in this section that require different levels of
experience, training and physical facilities. The 3 categories shall be:
(1) Simple compounding which includes
reconstituting or manipulating a commercial product that might require the
addition of one or more ingredients as directed by the manufacturer or preparing a product that has a USP compounding monograph or appears in a peer reviewed
article that contains the quantities
for all components, procedures and equipment with the exception of pre-measured
compounding kits;
(2) Moderate compounding which includes making a
preparation that requires complex calculation or procedures to determine
quantities of components per preparation or per individualized dosage units,
making a preparation for which stability data for that specific formulation is
not available and mixing 2 or more manufactured creams when the stability of
the mixture is unknown; and
(3) Complex compounding which includes making a
preparation that requires specialized training, environment, facilities,
equipment, and procedures such as transdermal dosage forms and modified-release
preparations.
(c)
Responsibilities of the compounder shall include:
(1) Compounding preparations of accepted
strength, quality, and purity and in accordance with the prescription or
medication order;
(2) Dispensing the
finished preparation, with appropriate packaging and labeling, and in
compliance with RSA 318:47-a, federal law, and other regulatory agencies where
appropriate;
(3) Maintaining proficiency in drug or dietary
supplement compounding;
(4) Ensuring
the quality of compounded preparation by adhering to the general principles
listed in USP 795 and all applicable compounding laws, guidelines and standards
including but not limited to:
a. Training of all the personnel shall be
current and documentation of such kept on site;
b. Compounding
ingredients shall be purchased from reliable sources and be properly stored;
c. Bulk component containers shall be properly
labeled and SDS sheets available;
d. Equipment used shall be clean, properly used
and maintained;
e. Environment shall be suitable to prevent
cross contamination including the use of powder containment systems if API’s
are used or powder is created through manipulation of solid dosage forms or
emptying of powder containing vials;
f. Compounding personnel shall wear appropriate
and clean clothing. Protective apparel
such as lab coats gowns, gloves, shoes, or masks shall be worn as necessary to
protect personnel from chemical exposure and/or contamination;
g. Only authorized personnel shall be allowed in
the compounding area;
h. Compounding conditions and procedures shall
be such to prevent errors;
i. There shall be assurance that processes are
always carried out as intended or specified and are reproducible;
j. All aspects of compounding shall be properly
documented;
k. Procedures and records exist for
investigating and correcting failures or problems in compounding and testing;
and
l. A valid and reproducible recall policy and
procedure.
(5) The compounder shall be responsible for
ensuring that each individual incidence of the compounding process meets the
criteria in USP 795.
(d)
The compounding area shall adhere to the general principles listed in
USP 795 guidelines including but not limited to:
(1) Adequate space
specifically designated for compounding and storage of equipment and materials;
(2) Be clean, orderly, and properly maintained;
(3) Easily accessible hand washing, hot and cold
water, soap or detergent, and an air-drier or single-use towels must be
present;
(4) Be located in a separate area from sterile
compounding area;
(5) Purified water
shall be used for compounding non-sterile drug preparations when formulations
indicate the inclusion of water;
(6) Disposal of
all hazardous drug wastes shall comply with applicable federal and state
regulations; and
(7) All personnel who perform routine custodial
waste removal and cleaning activities in storage and preparation areas for
hazardous drugs shall be trained in appropriate procedures to protect
themselves and prevent contamination including spill clean ups.
(e)
All equipment and utensils used in compounding shall comply with the
following:
(1) Be of appropriate design and capacity for the
required task;
(2) Automatic,
mechanical, electronic, or other equipment used in compounding shall be
routinely inspected, calibrated, or checked according to the manufacturer’s
recommendations to ensure proper performance; and
(3) Equipment shall be stored to protect it from
contamination. It shall be located in an
area to facilitate its use, cleaning and maintenance.
(f)
Component Selection, Handling and Storage shall be subject to the
following requirements:
(1) A United States Pharmacopeia (USP), National
Formulary (NF), or Food Chemicals Codex (FCC) substance shall be the
recommended source of ingredients for compounding all preparations.
(2) If ingredients
are from a non-FDA registered facility the professional judgment of the
compounder shall be used in selecting an acceptable and reliable source and
shall establish purity and safety including obtaining a certificate of analysis
from the manufacturer or qualified third party;
(3) Components for compounding shall be properly
labeled with lot numbers and expiration dates. If a component is transferred from the
original container to a new container, the new container shall be labeled with
the component name, original supplier, lot or control number, transfer date,
and expiration date and shall provide integrity that it is equal to or better
than the original container;
(4) For components that do not have expiration
dates assigned by the manufacturer or supplier the compounder shall label the
container with the date of receipt and assign a conservative expiration date
not to exceed 3 years after receipt;
(5) Written control procedures shall be
established to monitor the output and to validate the performance of those
compounding processes that might be responsible for causing variability in the
final drug product, including but
not limited to, the following:
a. Capsule weight variation;
b. Adequacy of mixing to insure uniformity and
homogeneity;
c. Clarity, completeness, or pH of solutions;
and
d. Observation of instability;
(6) When compounding with manufactured drug
products, the compounder shall consider all ingredients, including excipients,
present in the drug product relative to the intended use of the compounded
preparation and the effect of manipulating the drug product on the therapeutic
appropriateness and stability of the components;
(7) All components used in compounding shall be
stored as directed by the manufacturer, or according to USP or NF requirements,
in a clean, dry area under appropriate temperature conditions. All components shall be stored off the floor,
handled and stored to prevent contamination, and rotated so that the oldest
stock is used first. All containers
shall be properly labeled; and
(8) Use
of pre-measured compounding kits shall adhere to all USP 795 standards,
including the level of non-sterile compounding and utilizing a master
formulation record and a compounding record.
(g)
The following provisions of USP 795 shall be followed when determining
stability and beyond use dating:
(1) Compounders shall consult and apply
drug-specific and general stability information and literature when available;
(2) Compounders shall consider the following when
determining BUDs:
a. Nature of the drug and degradation mechanism;
b. Dosage form and its components;
c. Potential for microbial proliferation in the
preparation;
d. Container when it is packaged;
e. Intended duration of therapy; and
f. Expected storage conditions;
(3) When using manufactured solid dosage forms to
prepare a solution or aqueous suspension, the compounder shall also consider
factors such as hydrolysis, oxidation, and the freeze - thaw property of the
final preparation;
(4) When a manufactured product is used as the
source of the active pharmaceutical ingredient for a non-sterile compounded
preparation, the product expiration date shall not be used to assign a BUD for
the compounded preparation. Instead the
compounder shall refer to the manufacturer for stability information and to the
literature for applicable information on stability, compatibility, and
degradation of ingredients. All data shall be carefully interpreted in relation
to the actual compounded formulation;
(5) Susceptible preparations should contain
suitable antimicrobial agents to protect against bacteria, yeast, and mold
contamination inadvertently introduced during
or after the compounding process. When
antimicrobials are contraindicated, storage of the preparation at controlled
cold temperature shall be necessary to retard microbial growth. Appropriate patient or caregiver instruction
regarding storage and handling shall be essential;
(6) In the absence of reliable stability
information or published date the following general guidelines for maximum BUD
shall be:
a. A maximum of 6 months for non-aqueous
formulations;
b. A maximum of 14 days under refrigeration for
water-containing oral formulations; and
c. A maximum of 30 days for water containing
topical, dermal and mucosal liquid and semisolid formulations.
(7) The BUD shall not exceed the expiration date
of the API or any other component.
(h) The compounder shall ensure that the
containers and closures used in packaging compounded preparations meet the
following USP requirements:
(1) The containers and closures shall be made of
clean material in order not to alter the quality, strength, or purity of the
compounded preparation;
(2) Container-drug interaction shall be
considered for substances that have sorptive or
leaching properties; and
(3) Containers and
closures shall be handled and stored in such a way as to prevent contamination.
(i)
Compounders shall comply with the following requirements regarding
compound documentation;
(1) Documentation, written or electronic, shall
be kept for 4 years;
(2) Documentation shall comply with state and
federal laws;
(3) Documentation shall not be required when
preparing a compounded preparation according to the manufacturer’s labeled
instructions;
(4) The record may be a copy of the prescription
in written or machine-readable form and shall include a master formula record
and a compound record;
(5) Information contained in the master
formulation record shall include the
following:
a. Official or assigned name, strength, and
dosage form of the preparation;
b. Calculations needed to determine and verify
quantities of components and doses of active pharmaceutical ingredients;
c. Description of all ingredients and their
quantities;
d. Compatibility and stability information,
including references when available;
e. Equipment needed;
f. Mixing instructions;
g. Order of mixing;
h. Mixing temperature or other controls;
i. Duration of mixing;
j. Any other pertinent instruction;
k. Labeling information in addition to legally
required information found in RSA 318:47-a including:
1. Name and quantity or concentration of each
active ingredient;
2. Assigned BUD;
3. Storage conditions; and
4. Prescription number;
l. Container used in dispensing;
m. Packaging and storage requirements;
n. Description of final preparation; and
o. Quality control procedures and expected
results; and
(6) The compound record shall contain at least
the following:
a. Official or assigned name, strength, and
dosage of the preparation;
b. Master formulation record reference for the
preparation;
c. Names and quantities of all components;
d. Sources, lot numbers, and expiration dates of
components;
e. Total quantity compounded;
f. Name of the person who prepared the compound,
who performed the quality control procedures, and approved the preparation;
g. Date of the preparation;
h. Assigned controlled or prescription number;
i. Assigned BUD;
j. Description of final preparation;
k. Results of quality control procedures such as
weight range of filled capsules, pH record; and
l. Documentation of any QC issues and any ADRs
reported by patient or caregiver;
(j)
All significant procedures performed in the compounding area shall be
covered by written standard operating procedures (SOPs) including:
(1) Facility maintenance, workflow, and cleaning;
(2) Equipment use and maintenance;
(3) Personnel;
(4) Training;
(5) Preparation;
(6) Packaging;
(7) Storage of compounded preparations;
(8) Quality assurance;
(9) Safety;
(10) Uniformity;
(11) Continuous quality improvement; and
(12) Maintain updated SDS library.
(k)
The compounder shall perform the following to ensure quality control;
(1) Review calculation, ingredients, measurements
and procedures; and
(2) Observe the finished preparation to ensure
that it appears as expected and investigate any discrepancies and take
appropriate corrective action before the prescription is dispensed to the
patient.
(l)
The compounder shall ensure the following compounding controls are
followed:
(1) There are written procedures for the
compounding of drug preparations to ensure that the finished preparations have
the identity, strength, quality, and purity that they purport to have. These
procedures shall be available in either written form or electronically stored;
(2) The written procedures shall be followed in
execution of the compounding process;
(3) Check and document each weight and
measurement;
(4) Document the identity of the person(s)
actually performing the compounding;
(5) Document the name of compounder;
(6) Establish written procedures that will
describe quality assurance tests or examinations to be conducted on the
compounded preparation to ensure uniformity and integrity;
(7) To monitor the output and to validate the
performance of those compounding processes and equipment that could be
responsible for causing variability in the final compounded preparation; and
(8) Records shall be maintained with compounding
records for 10 years.
(m)
At the time of dispensing, the patient or the patient’s agent shall be
counseled about proper use, storage, handling, and disposal of the compounded
preparation. The patient or the
patient’s agent shall also be instructed to observe and report to the
compounder any changes in the physical characteristics of the compounded
preparation. Counseling may be in written, oral, electronic, or other formats. The compounding pharmacist shall investigate
any reported problem with a compounded preparation and take corrective action.
(n)
It shall be the responsibility of the compounder to ensure that a
training program has been implemented and that it is ongoing. Compounding
personnel shall be trained initially and the training shall be documented.
(o)
Steps in the training procedure shall include the following:
(1) All employees involved in pharmaceutical
compounding shall read and become familiar with USP Chapter 795. They shall also be familiar with other
relevant publications including how to read and interpret SDSs;
(2) All employees
shall read and become familiar with each of the procedures related to
compounding including those involving the facility, equipment, personnel,
actual compounding, evaluation, packaging, storage and dispensing;
(3) All personnel who compound hazardous drugs
shall be fully trained in the storage, handling and disposal of these
drugs. This training shall occur before
preparing or handling hazardous drugs;
(4) All training activities shall be
documented. The compounder shall meet
with employees to review their work and answer any questions the employee may
have concerning compounding procedures;
(5) The compounder shall demonstrate the
procedures for the employee and shall observe and guide the employee throughout
the training process. The employee shall
then repeat the procedure without any assistance from, but under the
supervision of the compounder;
(6) When the employee has demonstrated to the
compounder a verbal and functional knowledge of the procedure, then and only
then shall the employee be permitted to perform the procedure without direct
supervision. However the compounder
shall be physically present and shall approve all ingredients and their
quantities and the final preparation;
(7) When the compounder is satisfied with the
employee’s knowledge and proficiency, the compounder shall sign the
documentation records to show that the employee was appropriately trained;
(8) The compounder shall continually monitor the
work of the employee and ensure that the employee’s calculations and work are
accurate and adequately performed; and
(9) The compounder shall be solely responsible
for the finished preparation.
(p)
The following requirements shall be met when compounding for animal
patients:
(1) Intended use on any animal patient, such as
companion, performance or food, shall be determined before compounding for that
patient. Because humans can consume
animals as food, care shall be taken to prevent drug residue from entering the
human food chain;
(2) Compounders who compound for animals shall
possess knowledge of drug regulation, uses, dosing and disposition in animal patients to
properly determine appropriateness of therapy; and
(3) The
compounding pharmacist shall be knowledgeable about the individual species
limitations in physiology and metabolic capacity that can result in toxicity
when certain drugs or excipients are used in compounded preparations. For this reason, pharmacists compounding for
animals shall use when possible, formulations developed specifically for animal
patients. If such formulations are not
available, the compounding pharmacist shall conduct a literature review to
determine whether a specific component of the formula is toxic to the target
species. Compounded preparations shall
not to be dispensed or sold to veterinary offices for resale.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.04 Regulatory Requirements for Sterile
Compounding.
(a) A compounder shall have and
maintain a permit issued by the board that allows for the compounding of
sterile products as defined by the board.
(b)
When a compounder prepares more than 50 dosage units for non-patient
specific preparations the compounder shall be registered as a drug manufacturer
or 503B with the FDA.
(c) Compounders supplying limited
quantities, less than 50 dosage units, to providers for administration use
shall have an MOU with the provider for each compounded product they supply to
the provider. When a compounder provides
a practitioner a non-patient specific preparation, the compounder shall provide
the practitioner a copy of the test result for each lot provided to the
practitioner.
(d) Each batch of a high risk CSP shall be assigned a unique lot number
and shall be tested by an independent lab for sterility, potency, and
endotoxins. Only a batch that has passed
all 3 tests shall be made available to provide to a hospital or practitioner.
(e)
A compounder shall not compound a sterile product of an FDA-approved
product when the product is commercially available.
(f) When no commercial source of a sterile
product exists, such as being listed on the FDA backorder list, the compounder
shall only use USP or other USP recognized grades such as BP, JP, EP,
bulk ingredients obtained from a good manufacturing practice
compliant supplier. The compounder shall
obtain and keep on file for at least 3 years a certificate of analysis and
potency testing of all bulk ingredients used to compound each and every
compounded product made with a bulk, non-sterile ingredient.
(g)
A compounder who uses hazardous products shall meet state and federal
requirements for handling of hazardous agents.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.05 Sterile Quality Requirements.
(a)
Each compounder shall maintain documentation that confirms staff
training and competency related to proper garbing and hand hygiene, aseptic
technique and related practices, and cleaning and disinfection procedures prior
to compounding of any actual sterile product preparation.
(b)
Each compounder shall maintain documentation that confirms that the
compounder tests aseptic techniques of all staff that compounds sterile
products by preparing media fill units per USP standards.
(c)
Each compounder shall maintain documentation that confirms all staff
that compounds sterile products are pre-qualified using media fills before
compounding of actual drug preparations.
(d)
When a positive media fill occurs, compounder shall perform a
comprehensive investigation to identify root cause, and document the
finding.
(e)
When a positive media fill occurs, compounder shall institute corrective
and preventive action, and document the corrective action.
(f)
Each compounder shall verify that all personnel who compound sterile
products are complying with gowning, gloving, and glove-tip processes
consistent with USP standards by meeting the following requirements:
(1) Three glove
fingertip tests shall be performed initially then annually for low and medium risk compounding;
(2) Three glove
fingertip tests shall be performed initially then every 6 months for high risk
compounding; and
(3) Media fill tests shall be performed every 6
months for high risk compounding.
(g) Each compounder shall perform
routine surface microbiological and fungal environmental monitoring to minimize
contamination at least every 6 months, or in accordance with facilities
policies.
(h) Each compounder shall perform
comprehensive investigations of out-of-limit findings, as recommended by USP
standards to determine root cause, followed by corrective and preventative
actions at least weekly. Each compounder shall maintain all documentation of
its findings.
(i) Each compounder shall perform, at
least semi-annually, viable particle testing in primary engineering controls,
such as laminar flow workbench, biological safety cabinet and room air
according to USP standards.
(j)
Each compounder shall ensure that all compounded sterile products that
require refrigeration are stored in appropriate refrigeration at all times.
(k)
When a compounder assigns a BUD for a sterile product that exceeds BUD
limits established in USP standards, a compounder shall have laboratory testing
results that support extended expiration dating for compounded sterile
preparations to any patient or organization that request such
documentation.
(l)
Each compounder shall perform studies to determine extended expiration
dates, using evidence-based and validated stability testing procedures, for
compounded sterile preparations for which no extended expiration evidence
exists.
(m)
Each compounder shall have a policy that requires validation of new or
changed facilities, equipment, processes, container types, for sterility, and
repeatability.
(n) Each compounder shall have a
quality assurance program to promptly address equipment problems.
(o)
Each compounder shall have a quality assurance program for compounding
that includes at least the following separate, but integrated, components:
(1) Training;
(2) Standard operating procedures;
(3) Documentation;
(4) Verification;
(5) Testing;
(6) Cleaning and disinfecting;
(7) Containers, packaging and repackaging; and
(8) Storage.
(p)
Personnel involved in the compounding, evaluation, packaging and
dispensing of compounded preparations shall be properly trained and evaluated
to include:
(1) Three glove
fingertip tests shall be performed initially then annually for low and medium risk compounding; and
(2) Three glove fingertip tests shall be
performed initially then every 6 months for high risk compounding.
(q)
Personnel shall undergo re-qualification using media fills and glove fingertip tests annually for low
and medium risk sterile compounding and every 6 months thereafter for high risk
sterile compounding.
(r)
Each compounder shall have an action plan and alert limits for
environmental monitoring.
(s)
Each compounder shall develop and implement methods for improving
quality based on analyzed data found in its environmental monitoring.
(t)
Each compounder shall evaluate and continuously monitor the methods used
for the packaging, handling, and transport of CSPs.
(u) Each compounder shall evaluate and
continuously monitor the storage of CSPs to ensure compliance with appropriate
storage conditions.
(v)
Each compounder shall ensure drug storage refrigerators, freezers and
medication storage areas have daily monitoring and documentation of
temperatures.
(w) Compounder personnel shall inspect all drug
storage areas routinely to ensure drugs are stored separately from food.
(x)
Each compounder shall ensure all solutions, medications, equipment, and
supplies located in all areas are stored according to the manufacturer or USP
requirements and are inspected monthly for proper conditions of light,
temperature, moisture, and ventilation.
(y)
Each compounder shall ensure all outdated and unused CSPs are segregated
in a separate area for return and disposal.
(z) Each compounder shall ensure only
pharmacists training in sterile compounding determine whether a CSP not
administered as originally intended can be used for an alternate patient or
under alternate conditions.
(aa)
Each compounder shall have an environmental sampling plan based on the
compounding activities performed, locations to be monitored, the device used to
monitor, the frequency of collection, and procedures if readings exceed
established thresholds.
(ab)
The 2 types of monitoring that shall be used are:
(1) Non-viable monitoring which includes particle
counts, monitoring pressure or velocity difference between the buffer area,
ante area and non-classified area and shall be done at least every 6 months;
and
(2) Viable monitoring which detects microbial or
fungal contaminants in the compounding area and shall be done using a
volumetric collection method.
(ac)
Monitoring, sampling, and testing for surface contamination from
hazardous drugs is conducted at least every month or earlier in cases of
contamination from fluid or solid dosage form spills.
(ad) Compounder shall ensure
certification of its PEC complies with the requirements of USP Standards. Certification shall be done by an independent
entity certified to perform the test.
Each certifying entity shall leave a signed copy of the test with the
compounder who shall retain the document for at least 4 years.
(ae)
Each compounder shall ensure the PEC is certified every 6 months or
sooner if recommended by the manufacturer.
(af) Each compounder shall ensure viable and
non-viable airborne sampling occurs minimally every 6 months. Monitoring shall include all areas at risk of
contamination including but not limited to inside of PEC, counters, anteroom,
areas near doorways, and any pass-through, counters, storage areas, shelves,
shipping and receiving areas, and employee work areas.
(ag) Each compounder shall ensure
sampling data is base-lined, evaluated and documented on a routine basis as
defined by USP standards.
(ah)
Each compounder shall have a written plan and schedule for environmental
monitoring.
(ai)
Each compounder shall have a written environmental plan that adequately
evaluates the various controlled air environment areas including the PEC,
buffer area, and anteroom.
(aj) Compounder
facility personnel, or external personnel, who complete the environmental
monitoring shall be appropriately trained and certified by a national
certification entity.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.06 Compounding Environment.
(a)
Each compounder shall ensure there is sufficient space for the type and
amount of compounding done.
(b)
Each compounder shall ensure there is appropriate space for orderly
placement of equipment and materials to prevent mix-ups between ingredients,
containers, labels, in-process materials and finished preparations.
(c)
Each compounder shall ensure it has procedures to prevent
cross-contamination.
(d)
Each compounder shall ensure areas used for sterile preparation are
separate and distinct from areas used for non-sterile preparation.
(e)
Each compounder shall have a well-lighted compounding environment.
(f)
Each compounder shall ensure all heating, ventilation and air
conditioning systems are controlled to maintain a constant temperature 24 hours
per day, 7 days per week.
(g)
Each compounder shall maintain a bulk storage area that is adequately
arranged and proper temperature and humidity maintained.
(h)
Each compounder shall supply hot and cold potable water for hand and
equipment washing in the compounding area, and soap or detergent and single-use
towels or driers shall be readily available.
(i)
Each compounder shall ensure all compounding areas are maintained in a
clean and sanitary condition.
(j)
When compounder uses hard-wall construction, the finished surface shall
provide a non-porous, durable and washable surface.
(k)
The compound area shall meet the following requirements:
(1) All ceilings shall be smooth, impervious,
free from cracks and non-shedding, such as plastic covered clean room grade
ceiling tiles, and all tiles shall be sealed;
(2) All floors
shall be smooth, impervious, free from cracks and non-shedding, and the floor
must be of seamless vinyl;
(3) All fixtures
shall be smooth, impervious, free from cracks and non-shedding. All fixtures shall be mounted to wall in a
way that seals any space between wall and fixture;
(4) All shelving shall be smooth, impervious,
free from cracks and non-shedding;
(5) Counters shall be smooth, impervious, free
from cracks and non-shedding;
(6) All cabinets shall be smooth, impervious,
free from cracks and non-shedding;
(7) Ceiling to wall junctures shall be covered or
caulked to avoid cracks;
(8) Inlaid ceiling panels shall be impervious and
hydrophobic;
(9) Ceiling panels shall be caulked around the
perimeter to seal them to frame;
(10) Floors shall be overlaid with wide sheet
vinyl flooring with heat welded seams and coving to the sidewall;
(11) There shall be no dust-collecting overhangs;
(12) There shall be no windowsills;
(13) Exterior lens surface of ceiling light
fixtures shall be smooth, mounted flush, and sealed;
(14) There shall be no sinks in primary and
secondary compounding areas;
(15) There shall be no floor drains in primary and
secondary compounding areas;
(16) Carts shall be made of stainless steel wire
or sheet metal with cleanable casters;
(17) Carts
shall be mobile;
(18) All surfaces shall be designed to provide
effective cleaning;
(19) All surfaces shall be resistant to damage by
cleaning agents;
(20) There shall be no cardboard containers in
buffer area at any time;
(21) There shall be no computers, printers, radios
and refrigerators in the buffer area at any time;
(22) The bulk storage area shall be maintained in
a clean and sanitary condition;
(23) Trash shall be disposed of in a safe,
sanitary and timely manner; and
(24) All components, containers and equipment
shall be stored off the floor in a manner to prevent contamination and permit
inspection and cleaning of the compounding and storage area.
(l)
Each compounder shall ensure equipment is of appropriate design and size
for the compounding that is performed.
(m)
Each compounder shall ensure that all equipment is of appropriate design
such that the surface that contact pharmaceutical components, in-process
materials or finished preparations is not reactive, additive or adsorptive.
(n)
Each compounder shall ensure that all equipment is thoroughly cleaned
immediately after use to avoid cross-contamination.
(o)
Each compounder shall ensure
all equipment is stored to prevent it from contamination and is located to
facilitate its use, maintenance, and cleaning.
(p)
Each compounder shall ensure
all equipment used for allergenic ingredients is appropriately handled, cleaned
and stored immediately after use.
(q)
Each compounder shall ensure
all work surfaces are cleaned of loose materials and residue from spills before
compounding.
(r)
Each compounder shall ensure
all floors in the buffer area and ante area are mopped daily with a cleaning
and disinfecting agent at a time when no aseptic compounding is in progress.
(s)
Each compounder shall approve
all cleansing and sanitizing agents considering compatibilities, effectiveness,
and presence of inappropriate or toxic residues.
(t)
Each compounder shall ensure the following requirements are met:
(1) Mops, wipes, sponges, and other cleaning
materials shall be non-shedding and dedicated for use only in the sterile
compounding area;
(2) Cleaning tools shall be replaced as soon as
they are identified as unsuitable for use;
(3) All cleaning materials shall be disposable
and discarded after one use;
(4) All trash
shall be collected in suitable plastic bags and removed on a daily basis with
minimal agitation;
(5) Workspaces shall be cleaned and sanitized
daily including all buffer room
carts, equipment, workbenches, work surfaces, and floors, and document the
activity;
(6) Storage shelving in buffer and ante areas
shall be emptied of all supplies, cleaned, and sanitized at planned intervals
at least monthly;
(7) Walls and ceilings in buffer and ante areas
shall be cleaned at least monthly; and
(8) All equipment shall be clean, properly
maintained, validated and documented at appropriate intervals as defined by USP
Standards.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 404.07 Engineering Controls.
(a)
Each compounder shall ensure the PEC, LAFW and BSCs provide ISO Class 5
air quality;
(b)
Each compounder shall ensure
the buffer room maintains a minimum of an
ISO Class 7 air quality;
(c)
Each compounder shall ensure
the buffer room is designed to reduce the risk of contaminants being blown into
the primary compounding area, or
PCA. To be considered a clean room,
buffer area must meet specific air quality, HEPA filtration, air changes per
hour, and room pressure differentiation criteria to provide at least ISO Class
7 air quality.
(d)
Each compounder shall ensure
that within the buffer area, the PEC should be kept away from excess traffic,
doors, air vents, or anything that could introduce contaminates into the
workbench.
(e)
Each compounder shall ensure
that the anteroom is separate from buffer area.
(f)
Each compounder shall ensure
that the anteroom provides ISO Class 8 air quality, or ISO Class 7 air quality,
depending on the connecting buffer area.
(g)
Each compounder shall ensure
the anteroom area should store an adequate amount of gowning supplies but
should not be part of high traffic area or corridor.
(h)
Each compounder shall ensure
the anteroom is used to un-carton and sanitize all supplies to be taken into
buffer area.
(i)
Each compounder shall ensure sure the anteroom contains:
(1) Hand sanitizing equipment;
(2) Proper gowning equipment and space to
accommodate gowning activities;
(3) Faucet handles that shall be designed to be
hands-free; and
(4) That the
buffer area can be accessed without the use of hands.
(j)
Each compounder that only
compounds low and/or medium risk preparations, the ante room may be in the same
area as the buffer room, separated by a line of demarcation. However, a separate ante room shall be the
preferred method.
(k)
Each compounder that
compounds high risk preparations, the buffer room and the ante room shall be 2
separate rooms.
(l)
Each compounder shall ensure
all supplies brought into the buffer area are non-permeable, non-shedding, and
resistant to disinfectants.
(m)
Each compounder shall ensure
all materials exposed to patient care areas are kept out of the buffer area.
(n)
Each compounder shall ensure
the PECs are cleaned and disinfected at the beginning of each shift, before
each batch, at least every 30 minutes during compounding, when surfaces are
visibly soiled, and when surface contamination is known or even suspected.
(o)
Each compounder shall ensure all interior working surfaces are cleaned
and disinfected of LAFW from top to bottom, back to front, away from the HEPA
filter. Cleaning shall be performed with
purified water, and disinfecting with sterile 70% isopropyl alcohol or similar
antimicrobial, residue-free sanitizing agent.
(p)
Each compounder shall ensure
nothing shall be permitted to come in contact with the HEPA filter. This includes cleaning solutions, aspirate
from syringes, or glass from ampules, which shall not be broken towards the
filter.
(q)
Each compounder shall ensure air
exchange with the surrounding environment shall not occur unless the air is
first passed through a microbial retentive filter such as a HEPA system capable
of containing airborne concentrations of the physical size and state of the
drug being compounded. Where volatile
hazardous drugs are prepared, the exhaust air from the isolator shall be
appropriately removed by properly designed building ventilation.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
New. #10812, eff 4-18-15
Ph 404.08 Compounding Procedures.
(a)
Each compounder shall ensure
that all personnel adhere to the following when they are in the LAFW or buffer
areas:
(1) No smoking, food, drink, or chewing gum shall
be allowed in the buffer area at any
time;
(2) No jewelry shall be worn on the hands or wrists and
there shall be no visible piercings;
(3) No make-up shall be worn in the buffer area as it can shed particles;
(4) Before putting on gloves, the nails shall be
cleaned, and the hands, wrists, and forearms shall be washed thoroughly for at
least 30 seconds with warm water and antimicrobial skin cleanser;
(5) Personnel shall appropriately utilize gowns,
masks, gloves, hair covers, and shoe covers;
(6) No paper, pens, labels, or trays shall be placed in the workbench; and
(7) No objects that shed particles shall be brought into the buffer area such
as cardboard cartons, paper towels, and cotton items.
(b)
Each compounder shall ensure when cleaning and disinfecting the interior
work surfaces of the LAFW it is done from top to bottom, back to front, away
for the HEPA filter.
(c)
Each compounder shall ensure personnel check the quality, purity,
amount, and identity of all ingredients.
(d)
Each compounder shall ensure all personnel use the correct compounding
procedures when compounding sterile products, and periodically disinfect gloves
with sterile 70% isopropyl alcohol and allow them to dry thoroughly before
continuing.
(e)
Each compounder shall ensure that open and partially used containers are
properly labeled and stored.
(f)
Each compounder shall ensure
the following:
(1) CSP has an appropriate BUD that is identified on all product
labels;
(2) When the BUD exceeds USP standards, it is
based on scientific criteria;
(3) Packaging is appropriate for sterility and
stability;
(4) Product labels are appropriate and complete
for safe use; and
(5) Products are visually inspected for physical
integrity during and after compounding, and a final check of the CSP is
performed.
(g)
Each compounder shall ensure
any deficiencies in compounding procedures can be rapidly identified and
corrected.
(h)
Each compounder shall ensure that finished compounded products are
maintained in a separate area away from the active compounding area, and that
no more than 2 entries into any one sterile container or sterile administration
device.
(i)
Each compounder shall ensure
all compounding activity only involves closed or sealed packaging systems.
(j)
In the absence of stability and sterility testing of any CSP the
compounder shall use BUD based on USP standards as defined for the following
CSPs:
(1) Low risk compounded product storage shall not
exceed 48 hours at room temperature, 14 days at cold temperature or 45 days in
a frozen state if the stability of the product allows;
(2) Medium risk compounded product storage shall
not exceed 30 hours at controlled room temperature, 9 days at cold temperature
or 45 days in a frozen state;
(3) High risk compounded product storage shall not exceed 24 hours at
room temperature, 3 days at cold
temperature or 45 days in a frozen state.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15; ss by #13388, EMERGENCY
RULE, eff 5-25-22, EXPIRED 11-21-22, and #10812 effective again pursuant to RSA
541-A:18, V
Ph 404.09 Records Management.
(a)
Compounder shall maintain the following records related to compounding
of sterile products for at least 4 years:
(1) PEC certification records;
(2) GAP analyses; and
(3) Detailed formulation record of each sterile
compounded preparation that includes:
a. Name of preparation, strength and dosage
form;
b. All ingredients and their quantities;
c. Equipment used for the preparation;
d. Add mixing instructions to include order of
mixing, temperatures, duration of mixing and other pertinent factors;
e. Assigned beyond-use date;
f. Container used;
g. Storage requirements; and
h. Quality control procedures.
(b)
Each compounder shall have
procedures developed for the facility, equipment, personnel, preparation,
packaging and storage of compounded preparation to ensure accountability,
accuracy, quality, safety, and uniformity in compounding.
(c)
Each compounder shall have a procedure for recalls. The recall file shall be maintained with
information concerning any applicable recalled products affecting the pharmacy.
(d)
Each compounder shall perform
and maintain a quality control history and quality assurance trend reports on a
quarterly basis and upon request.
(e)
Each compounder shall
maintain documentation that confirms that sterile media used is certified by
the manufacturer to be sterile and guaranteed to promote growth.
(f)
Each compounder shall
maintain detailed reports on the incidence of positive media test results and
the follow-up retests after corrective action is completed.
(g)
Each compounder shall provide
a guaranteed shelf life upon delivery. This date shall be based on USP
Standards, or based on established scientific criteria.
(h)
Each compounder shall
document processes and procedures including shipping validation studies to
ensure that preparations leaving the site retain their integrity and stability
through the shipping cycle.
(i)
Each compounder shall ensure
that all personnel annually receive live training and visual process validation
including written documentation of both processes.
(j)
Each compounder shall
maintain documentation that it’s cleaning methods and agents are effective in
preventing contamination of the sterile preparations area.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
PART Ph 405 STANDARDS OF PRACTICE FOR NUCLEAR/RADIOLOGIC
PHARMACY
Ph 405.01 Purpose. The practice of nuclear pharmacy is hereby
recognized as a specialty of pharmacy practice, regulated by the state board of
pharmacy. As such, the following rules
are included to address those areas specific or unique to this specialty
practice.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 405.02 Definitions.
(a)
"Authentication of product history" means identifying the
purchasing source, the ultimate fate, and any intermediate handling of any
component of a radiopharmaceutical or other drug.
(b)
"Nuclear pharmacy" means a pharmacy which provides
radiopharmaceutical services.
(c) "Practice of nuclear
pharmacy" means a patient-oriented service that embodies the scientific
knowledge and professional judgment required to improve and promote health
through the assurance of the safe and efficacious use of radiopharmaceuticals
and other drugs.
(d)
"Quality assurance procedures" means all activities necessary
to guarantee the integrity of the process used to provide radiopharmaceutical
services, including authentication of product history and maintenance of all
records as required by the department of health and human services, bureau of
radiological health.
(e)
"Quality control testing" means the performance of chemical,
biological and physical tests on compounded radiopharmaceuticals and the
interpretation of the resulting data to determine their suitability for use in
humans and animals.
(f)
"Radiopharmaceutical" means any drug which exhibits
spontaneous disintegration of unstable nuclei with the emission of nuclear
particles or photons. The term includes
any nonradioactive reagent kit or nuclide generator which is intended to be
used in the preparation of any such substance, but does not include drugs such
as carbon-containing compounds or potassium-containing salts which contain
trace quantities of naturally occurring radionuclides. The term also includes any biological product
which is labeled with a radionuclide or intended solely to be labeled with a
radionuclide.
(g) "Radiopharmaceutical
service" means the procurement, storage, handling, compounding,
preparation, labeling, quality control testing, dispensing, distribution,
transfer, record keeping and disposal of radiochemicals,
radiopharmaceuticals and ancillary drugs.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 405.03 General Requirements for Pharmacies
Providing Radiopharmaceutical Services.
(a)
A permit to operate a pharmacy which provides radiopharmaceutical
services shall only be issued to a person who is, or who employs, a qualified
nuclear pharmacist. All personnel
performing tasks in the preparation and distribution of radiopharmaceuticals
and ancillary drugs shall be under the direct supervision of a qualified
nuclear pharmacist, who shall be in personal attendance when the pharmacy is
open for business. The
pharmacist-in-charge shall be responsible for all operations of the pharmacy.
(b)
The nuclear pharmacist who licenses the pharmacy shall hold a current
license issued by the board, and be either certified as a nuclear pharmacist by
the board of pharmaceutical specialties or satisfy each of the following
requirements:
(1) Meets minimal standards of training for
status as authorized user of radioactive material, as specified by the
department of health and human services, bureau of radiological health;
(2) Has
successfully completed a minimum of 200 contact hours of instruction in nuclear
pharmacy and the safe handling and use of radioactive materials from a
nationally accredited college of pharmacy, or other training program recognized
by the department of health and human services, bureau of radiological health;
(3) The 200 hours of instruction referenced in
(2) above shall be apportioned as follows:
a. Radiation physics and instrumentation, 85
hours;
b. Radiation protection, 45 hours;
c. Mathematics pertaining to the use and
measurement of radioactivity, 20 hours;
d. Radiation biology, 20 hours; and
e. Radiopharmaceutical chemistry, 30 hours;
(4) Has attained a minimum of 500 hours of
clinical/practical nuclear pharmacy training under the supervision of a
qualified nuclear pharmacist in, but not limited to, the following areas:
a. Procuring radioactive materials;
b. Compounding radiopharmaceuticals;
c. Performing routine quality control
procedures;
d. Dispensing radiopharmaceuticals;
e. Distributing radiopharmaceuticals;
f. Implementing basic radiation protection
procedures; and
g. Consulting and educating the nuclear medicine
community, patients, pharmacists, other health professionals, and the general
public; and
(5) Has submitted an affidavit of experience and
training to the board.
(c)
The permit to operate a nuclear pharmacy shall be effective only so long
as the pharmacy also holds a current license issued by the department of health
and human services, bureau of radiological health. Copies of the bureau of radiological health
inspection reports shall be available at the pharmacy for board inspection.
(d)
Nuclear pharmacies shall have adequate space and equipment, commensurate
with the scope of services required and provided and meeting minimal space
requirements established for all pharmacies in the state.
(e)
All pharmacies handling radiopharmaceuticals shall include, but not be
limited to, the following areas:
(1) Radiopharmaceutical preparation/dispensing
area;
(2) Radioactive material shipping/receiving area;
(3) Radioactive material storage area; and
(4) Radioactive waste decay area.
(f)
The application for a permit to operate a nuclear pharmacy shall be the
same as in Ph 304.01 and Ph 304.02.
(g)
The nuclear pharmacy professional service area shall be secured from
unauthorized personnel and shall be totally enclosed and lockable.
(h)
Nuclear pharmacies shall maintain records of acquisition, inventory and
disposition of all radioactive drugs and other radioactive materials in
accordance with the board and the department of health and human services,
bureau of radiological health statutes and rules.
(i)
A radiopharmaceutical shall be dispensed only to a licensed practitioner
authorized by the department of health and human services, bureau of
radiological health to possess, use and administer such drug. A radiopharmaceutical shall be dispensed only
upon receipt of a prescription or medication order from such licensed
practitioner. Otherwise, a
radiopharmaceutical may be transferred to a person who is authorized to possess
and use such drug for non-clinical applications.
(j)
A nuclear pharmacy, upon receiving an oral prescription order for a
radiopharmaceutical, shall immediately have the prescription order reduced to
writing, or recorded in a data processing system.
(k)
The writing or record required by (i) above shall contain at least the
following:
(1) The name of the institution and prescriber,
or prescribers' agent;
(2) The date of dispensing and the calibration
time of the radiopharmaceutical;
(3) The name of the procedure;
(4) The name of the radiopharmaceutical;
(5) The dose or quantity of the
radiopharmaceutical;
(6) The serial number assigned to the order for
the radiopharmaceutical;
(7) Any specific instructions;
(8) The initials of the person who received the
order; and
(9) The initials of the person who dispensed the
order.
(l)
Whenever an order is for a therapeutic or blood‑product
radiopharmaceutical, the patient's name shall be obtained and recorded prior to
dispensing.
(m)
The immediate outer container shield of a radiopharmaceutical to be
dispensed shall be labeled with:
(1) The name and address of the pharmacy;
(2) The name of the prescriber;
(3) The date of dispensing;
(4) The serial number assigned to the order for
the radiopharmaceutical;
(5) The standard radiation symbol;
(6) The words "Caution Radioactive
Material";
(7) The name of the procedure;
(8) The radionuclide and chemical form;
(9) The amount of radioactivity and the
calibration date and time;
(10) If a liquid, the volume;
(11) If a solid, the number of items or weight;
(12) If a gas, the number of ampules or vials;
(13) Molybdenum 99 content to USP limits; and
(14) The name of the patient or the words
"Physician's Use Only" in the absence of a patient name.
(n)
When the prescription is for a therapeutic or blood-product
radiopharmaceutical, the patient name shall appear on the label. The requirements of this paragraph shall be
met when the name of the patient is readily retrievable from the physician upon
demand.
(o)
The immediate inner container label of a radiopharmaceutical to be
dispensed shall be labeled with:
(1) The name of the pharmacy;
(2) The standard radiation symbol;
(3) The words "Caution Radioactive
Material";
(4) The identity of the radionuclide;
(5) The chemical form;
(6) The name of the procedure; and
(7) Serial number of the radiopharmaceutical.
(p)
When a radiopharmaceutical is dispensed under the authority of an
investigational new drug application (
(q)
Each nuclear pharmacy shall have a current copy of the United States
Pharmacopeia/National Formulary (USP/NF), USP-DI, and a current copy of state
and federal rules and regulations governing the safe storage, handling, use,
dispensing, transport and disposal of radiopharmaceuticals.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
Ph 405.04 Minimum Equipment. The pharmacy shall have at least the
following equipment:
(a)
A radionuclide dose calibrator;
(b)
A refrigerator;
(c)
A single or multiple channel scintillation counter with well-type NaI (Tl) or Ge (Li) detector;
(d)
A radiochemical fume hood and filter system with air sampling equipment;
(e)
An area survey meter;
(f)
At least 2 Geiger Mueller survey meters including one high-range meter;
(g)
A microscope and hemacytometer;
(h) A laminar air flow hood and
appropriate supplies to ensure sterile practices for parenteral solutions;
(i)
Syringe and vial radiation shields;
(j)
A lead‑shielded drawing station;
(k)
Decontamination supplies;
(l)
Supplies to perform quality assurance testing;
(m)
Lead transport shields for syringes and vials; and
(n)
United States Department of
Transportation approved USA Type A ‑ 7A transport containers and other
labels and supplies for shipping radioactive materials.
Source. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10812, eff 4-18-15
CHAPTER Ph
500 ETHICAL STANDARDS
PART Ph 501
CODE OF ETHICS
Ph
501.01 Standards of Conduct for
Pharmacists.
(a) The ethical standards set forth in this part
shall bind all licensed pharmacists, and a violation of any such standard shall
be a basis for the imposition of disciplinary sanctions.
(b) A licensed pharmacist shall comply with the
law and accept the following ethical principles:
(1) Hold
the health and safety of patients to be of first consideration and render to
each patient the full measure of the pharmacist’s ability as an essential
health practitioner;
(2)
Never condone the dispensing, promoting or distributing of drugs or
medical devices, or assist therein, that do not meet standards required by law
or that, in the pharmacist’s professional judgment, lack therapeutic value for the patient;
(3)
Always strive to perfect and enlarge the pharmacist’s professional
knowledge;
(4)
Utilize and make available the pharmacist’s knowledge as might be
required in accordance with the pharmacist’s best professional judgment;
(5) Not
engage in any activity that will bring discredit to the profession, and report,
without fear or favor, illegal or unethical conduct in the profession to the
OPLC, board, or other appropriate authority;
(6)
Never agree to or participate in transactions with practitioners of
other health professions or any other person under which fees are divided or that might cause financial
or other exploitation in connection with the rendering of professional
services;
(7)
Respect the confidential and personal nature of professional records,
and disclose such information only as allowed by state or
federal law;
(8) Not
knowingly agree to practice under terms or conditions that prevent the proper
exercise of professional judgment and skill or otherwise cause a deterioration
of the quality of the pharmacist’s service or that require the pharmacist to
consent to unethical conduct, provided, however, that nothing in this paragraph
shall require a pharmacist to cease operations based on insufficient support
staffing;
(9)
Refrain from advertising professional services in a manner that is
misleading to the public or that conveys by implication that the services of
other licensed pharmacists are unethical or inferior;
(10)
Maintain a sanitary and orderly work area that is fully equipped and
stocked to meet the needs of the population or other
clients served by the pharmacy;
and
(11)
Fulfill all professional obligations conscientiously and with due
respect for the well-being of the population or other
clients served by the pharmacy,
and uphold at all times the standards of the profession of pharmacy.
Source. #2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #10455, eff 11-1-13;
ss by #14063, eff 8-22-24
CHAPTER Ph 600 LIMITED RETAIL DRUG DISTRIBUTOR
Statutory Authority: RSA 318:51-b
PART Ph 601 LICENSING OF LIMITED
RETAIL DRUG DISTRIBUTORS
Ph 601.01 License Required.
(a) No
person shall act as a limited retail drug distributor, as defined in RSA
318:1,VII-a, without first obtaining a license to do so from the board according to RSA 318:51-b.
(b) No
license shall be issued or renewed for a limited retail drug distributor unless
the same shall be operated in a manner prescribed by RSA 318:51-b and according
to Ph 600.
(c) Separate licenses shall be required for each
site owned and operated by the limited retail drug distributor.
(d) The board shall provide, on a biennial basis,
a license renewal application to all licensed limited retail drug
distributors. The biennial license shall
expire on June 30th of every odd-numbered year. Licensees shall file the renewal application
and pay the fee in (e) below by June 15th of every odd-numbered
year.
(e) The
prescribed fee for initial and biennial renewal licenses for limited retail
drug distributors shall be:
(1) For clinics under contract
with the department of health and human services (DHHS), $300;
(2) For methadone
maintenance/detoxification treatment centers, $500; and
(3) For medical gas suppliers,
$300.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #8572, eff 2-23-06; amd by #9139-B, eff
4-25-08; paragraphs (a)-(d) EXPIRED: 2-23-14;
paragraph (e) EXPIRED: 4-25-16
New. #12335, eff 7-22-17; ss by #13117, eff
10-15-20
Ph 601.02 Obtaining and Filing a License Application.
(a) Applications for licensure of limited retail
drug distributors may be obtained from and filed at the board office,
identified in Ph 103.03.
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17
Ph 601.03 Application Contents.
(a) The applicant for licensure shall complete
and submit a “Limited Retail Drug Distributor of Medical Gases and/or Medical
Devices” form, form MM-1, revised June 2017.
(b) The applicant shall also submit the
following:
(1) A scaled drawing of the
facility;
(2) A copy of the state license
from the state licensing agency where the facility is located, if such facility
is outside New Hampshire, or an explanation detailing why the applicant does
not have such a license; and
(3) A copy of the facility’s most
recent inspection report completed by the state licensing board or agency where
the facility is domiciled, if it is located outside New Hampshire, or an
explanation detailing why the applicant does not have such an inspection
report.
(c) The applicant shall supplement the
application specified in (a) and (b) above with any certificates, affidavits,
plans, documents or other information sufficient to show full compliance with
all of the requirements of Ph 600.
(d) If the applicant is a corporation, or the
limited retail drug distributor will be operated under a corporate name, a
certificate from the NH secretary of state attesting to the documents creating
the corporate person and any amendment(s) thereof to the certificate of
incorporation, or authorizing it to do business in the state of New Hampshire
under the corporate name shall be included with the application.
(e) If the applicant proposes to hold, store, or
dispense controlled substances as a methadone maintenance/detoxification
facility, the application shall be supplemented with the following information:
(1) A brief description of the
security system;
(2) A list of all persons with
access to the controlled substances;
(3) The applicant shall supplement the
application specified in (a) above with any certificates, affidavits, plans, documents or other information
sufficient to show full compliance with all of the requirements for operation
of a drug abuse treatment facility, as outlined in He-A 304; and
(4) If the application is for a
methadone maintenance/detoxification facility, the applicant shall submit the
current registration number issued by the federal drug enforcement
administration (DEA).
(f) The applicant shall sign, indicate his or her
title, and date the application under the following affirmation:
“I affirm that I am the person authorized to sign this application for
licensure and declare under penalties of unsworn falsification under RSA 641:3
that this application (including any accompanying documents) has been examined
by me and to the best of my knowledge and belief is a true, correct and
complete application, and if the registration herein applied for is granted, I
hereby agree to and do submit to the jurisdiction of the New Hampshire board of
pharmacy and to the laws and rules of this state.”
(g) The board shall issue a
license pursuant to this section if the applicant:
(1) Files a complete application
that meets the requirements of these rules and RSA 318; and
(2) Is of good moral character,
or, if the applicant is an association or corporation, that the managing
officers are of good moral character, as evidenced by the absence, within the
last 5 years, of conviction of any felony, or of a misdemeanor resulting from a
violation of any drug related law of the United States or of any state.
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17
Ph 601.04 Consultant Pharmacist. All applicants licensed under the provisions
of RSA 318:51-b shall have a written
contract with a pharmacist, licensed in NH, to serve as a consultant on all
matters relating to procurement, storage and dispensing of prescription drugs
as defined in RSA 318:1, XVII.
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17
Ph 601.05 Changes in Supporting Information. The applicant shall notify the board,
immediately, of any changes of information
from that which was submitted on the original application pursuant to Ph
601.03. Failure to report changes shall
result in the imposition of a $25 administrative fine. No license shall be issued until all fees and
fines are paid in full.
Source. #8572, eff 2-23-06; ss by
#9139-B, eff 4-25-08, EXPIRED:
4-25-16
New. #12335, eff 7-22-17
Ph 601.06 Renewal Applications.
(a)
The license period shall be from July 1 thru June 30 of every
odd-numbered year.
(b)
Applications for renewal of a license to operate as a limited retail
drug distributor shall consist of prescribed fee as indicated in Ph 601.01(e)
and the following appropriate application form:
(1) For medical gas suppliers, the online License
Renewal Application available
at https://nhlicenses.nh.gov/eGov/Login.aspx;
(2) For clinics under contract with DHHS,the online License Renewal Application, available at https://nhlicenses.nh.gov/eGov/Login.aspx ; or
(3) For methadone maintenance/detoxification facilities,the online License Renewal Application,
available at https://nhlicenses.nh.gov/eGov/Login.aspx.
(c) Medical
gas supplier and methadone maintenance/detoxification renewal applicants shall
submit the following additional information with their renewal applications:
(1) For
medical gas suppliers:
a. A
copy of the current state license from the applicant’s home state licensing
authority if outside New Hampshire, or an explanation as to why the renewal
applicant does not have such a license; and
b. A
copy of the most recent inspection report from the applicant’s home state
licensing authority if outside New Hampshire, or an explanation as to why the
renewal applicant does not have such an inspection report; and
(2) For
methadone maintenance/detoxification facilities:
a. A
copy of the clinic’s current New Hampshire DHHS certified drug treatment
provider certificate; and
b. A
copy of the clinic’s current DEA registration.
(d) Renewal applications shall include a dated
signature and title under the following affirmations:
(1) For
medical gas suppliers:
“I affirm that I am the person authorized to
sign this application for licensure on behalf of the company/licensee and
affirm that this application (including any accompanying documents) has been
examined by me and to the best of my knowledge and belief is a true, correct
and complete application, and if the registration herein applied for is
granted, I hereby agree to and do submit to the jurisdiction of the New
Hampshire Board of Pharmacy and to the laws and rules of this State.”
(2) For
clinics under contract with DHHS:
“I declare under penalties of unsworn
falsification under RSA 641:3 that this application (including any accompanying
documents) has been examined by me and to the best of my knowledge and belief
is a true, correct and complete application, and if the permit herein applied
for is granted, I hereby agree to and do submit to the jurisdiction of the New
Hampshire Board of Pharmacy and to the laws and rules of this State.”; and
(3) For
methadone maintenance/detoxification facilities:
“I declare under penalties of unsworn
falsification under RSA 641:3 that this application (including any accompanying
documents) has been examined by me and to the best of my knowledge and belief
is a true, correct and complete application, and if the permit herein applied
for is granted, I hereby agree to and do submit to the jurisdiction of the New
Hampshire Board of Pharmacy and to the laws and rules of this State. To the
best of my knowledge, myself nor any of the employees listed on this application,
have been arrested, investigated for, charged with, convicted of, sentenced,
entered a plea of non contendere, or entered into any other legal agreements
for any criminal offense in any state, territory or possession of the United
States or by the federal government.”
(e)
The board shall renew a license pursuant to this section if the
applicant:
(1) Files a complete application that meets the
requirements of these rules and RSA 318; and
(2) Is of good moral character, or, if the
applicant is an association or corporation, that the managing officers are of good moral character, as evidenced by the absence,
within the last 5 years, of conviction of any felony, or of a misdemeanor
resulting from a violation of any drug related law of the United States or of
any state.
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17; ss by #13117, eff
10-15-20
Ph 601.07 Temperature. The temperature in any area wherein drugs are
compounded shall, at all times, be in compliance with the standards established
by the United States Pharmacopoeia as defined in Ph 701.02(s).
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17
Ph 601.08 Quarantine. Any drug, which is adulterated as defined in
Ph 701.02(a) or misbranded as defined in Ph 701.02(j), shall be removed from
the routine stock and held in a specifically designated secure area of the
facility pending proper and safe disposition.
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17
Ph 601.09 Space.
Drugs shall be housed in a well-lighted and ventilated room or
department with clean and sanitary surroundings.
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17
Ph 601.10 Security.
(a) That portion of the facility where drugs are
stored, compounded, or dispensed, shall be lockable so as to prevent entry into
that area by any person or persons without the knowledge of the authorized
individuals on duty, or when the facility is not open.
(b)
If the facility contains controlled substances, it shall be equipped
with an alarm system as referenced in Ph 1002.03.
(c)
Methadone maintenance or detoxification facilities shall ensure that all
access from outside their premises is secure.
This shall include, but not be limited to, the installation of adequate
lighting to illuminate the outside perimeter of the premises.
(d)
All controlled substances shall be stored pursuant to the security
provisions outlined in 21 CFR 1301.72(a).
(e)
For all facilities, the consultant pharmacist shall visit, at least
quarterly, all areas of the facility where drugs are stored.
(f)
The consultant pharmacist shall create a written record of each
quarterly inspection, specified in (e), which shall be maintained on site for a
period of at least 2 years and be available to the board upon request.
(g)
The pharmacist shall ensure that the areas specified in (e) above are in
compliance with federal and state drug laws relative to security, drug
distribution, and product tampering.
(h)
The pharmacist shall ensure that all drugs are properly labeled, have
not reached their expiration date, and show no signs of deterioration. Any drugs not conforming to these standards
shall be removed from stock.
(i)
The consultant pharmacist shall develop a distribution system that
prevents the illegal diversion of drugs.
Where applicable, the inventory of all schedule II controlled substances
and other controlled drugs stored in any area of the facility, shall be checked
by 2 persons at least every 24 hours and accountability records shall be
completed by the nursing or medical staff and maintained on-site for inspection
by the consultant pharmacist.
(j) Notwithstanding (i) above, in situations at
the methadone maintenance or detoxification facilities that result in only one
staff member being present, the inventory shall be counted, signed, dated, and
shall be “cosigned” immediately upon the presence of a second staff
member. However, at no time shall there
lapse more than 72 hours before this inventory verification by a second party.
Source. #8572, eff 2-23-06; amd by
#9139-B, eff 4-25-08; paragraphs (a)-(g)
EXPIRED: 2-23-14; paragraph (h) EXPIRED: 4-25-16
New. #12335, eff 7-22-17; ss by #13669, eff
8-20-23
Ph 601.11 Dispensing Practices.
(a) Drugs shall be dispensed only by or in the
presence of and under the supervision of a pharmacist, physician, advanced
registered nurse practitioner, physician assistant, or registered nurse as
identified in RSA 318:42,VII (a), in compliance with state and federal
pharmacy-related laws and rules.
(b)
In the case of methadone
maintenance/detoxification facilities and according to the provisions of RSA
318:42 the dispensing of narcotics is extended to employees of the clinic,
authorized in writing according to the provisions of 21 CFR 1301.74(i) of the
federal law.
Source. #8572, eff 2-23-06; amd by
#9139-B, eff 4-25-08; paragraphs (c) and (d) EXPIRED: 2-23-14 paragraphs (a)
& (b) EXPIRED: 4-25-16
New. #12335, eff 7-22-17
Ph 601.12 Deliveries.
(a) All drug order deliveries containing
prescription drugs shall be delivered only when a licensed practitioner is on
the premises in order to secure such drug orders.
(b) In the case of methadone
maintenance/detoxification facilities, drug deliveries may be accepted only by
the licensed practitioner or other individuals identified according to the
requirements of 21 CFR 1301.74(h).
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17
Ph 601.13 Access to Drug Supply.
(a) Only the pharmacist, physician, advanced
registered nurse practitioner, physician assistant or registered nurse, as
identified in RSA 318:42 shall have access to the drug supply.
(b)
In the case of methadone maintenance/detoxification facilities, access
to the drug storage area may also be extended to licensed
practical nurses provided such authorization is granted, in writing, according
to the provisions of 21 CFR 1301.72(d) of the federal law.
(c)
Methadone maintenance/detoxification facilities shall supply the board
with a list of all individuals that have been granted access to the drug supply, and, should this list change,
the board shall be notified, in writing, within 72 hours of such changes.
Source. #8572, eff 2-23-06; ss by
#9139-B, eff 4-25-08 EXPIRED:
4-25-16
New. #12335, eff 7-22-17
Ph 601.14 Dispensing Records.
(a) A readily retrievable record, completed by
the nursing or medical staff, shall be made of all administration or dispensing
of prescription drugs from the facility.
(b) The record, as specified in (a) above, shall
be separate from the patient’s medical record and include:
(1) Name and address of the
patient;
(2) Date of administration or
dispensing;
(3) Name, strength and quantity of
drug(s) administered or dispensed;
(4) Identity of the prescriber;
and
(5) Signature of the person
administering or dispensing.
(c) Methadone maintenance/detoxification
facilities shall maintain a dispensing log, completed by the nursing or medical
staff, containing the following information:
(1) Name of substance;
(2) Strength of substance;
(3) Dosage form;
(4) Date administered;
(5) Patient identification number;
(6) Amount consumed;
(7) Amount and dosage form taken
home; and
(8) Dispenser’s signature.
(d) Records of administrations and dispensing as
specified in (b) and (c) above shall be maintained for a period of 4
years. Such records shall be open to
inspection by the pharmacy board and its agents during regular business hours.
Source. #8572, eff 2-23-06; amd by
#9139-B, eff 4-25-08; paragraphs (a)-(c)(4), (c)(6)-(7), & (d) EXPIRED:
2-23-14 paragraph (c) intro. & (c)(5) EXPIRED: 4-25-16
New. #12335, eff 7-22-17
Ph 601.15 Prescription Labels.
(a) Whenever an authorized practitioner dispenses
a controlled drug, as defined in RSA 318-B:1-a and b, or a non-controlled
prescription drug, as defined in RSA 318:1, XVII, he/she shall affix to the
container in which such drug is dispensed, a label showing at least:
(1) Name and address of the
facility;
(2) Name of the patient;
(3) Date dispensed;
(4) Name, strength and quantity of
drug dispensed;
(5) Directions for use;
(6) Name of the prescribing
practitioner;
(7) Name or initials of the
dispensing practitioner; and
(8) All pertinent auxiliary
labels.
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17
Ph 601.16 Labeling Exemption. The labeling requirements, as specified in Ph
601.15, shall be exempted when medication is being administered for immediate
consumption, such as in a methadone maintenance/detoxification facility.
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17
Ph 601.17 Violations. Any person who distributes legend drugs
according to RSA 318:51-b and the provisions of Ph 600, shall be subject to
disciplinary action as provided in RSA 318:29.
Source. #8572, eff 2-23-06, EXPIRED:
2-23-14
New. #12335, eff 7-22-17
PART Ph 602 MEDICAL GASES
Ph 602.01 Biennial Registration Required. Pursuant to Ph 601.06, every person, or
corporate entity that is not a licensed pharmacy, engaged in supplying medical gases to the
consuming public, or to a patient or a patient's agent, in the state of New
Hampshire, shall renew biennially with the board as a limited retail drug
distributor no later than June 15th of every odd-numbered year.
Source. #12335, eff 7-22-17; ss by #13117, eff
10-15-20
Ph 602.02 Medical Gas Supplier Requirements.
(a) The limited retail drug distributor license
shall be posted in a conspicuous place in the wholesaler's place of business
for which it is issued.
(b)
A medical gas supplier shall not:
(1) Supply prescription medications, except
medical gases, without appropriate licensure as a limited retail drug
distributor;
(2) Manufacture or distribute medical gases
without appropriate licensure as a limited retail drug distributor; or
(3) Instruct patients regarding clinical use of
equipment, or provide any monitoring, assessment, or other evaluation of
therapeutic effects without appropriate licensure as a respiratory care
practitioner.
(c) A medical gas supplier shall supply medical
gas only pursuant to prescription order by an authorized prescriber.
(d) A medical gas supplier shall label each
medical gas container with the name, address, and telephone number of the
supplier.
(e) A medical gas supplier shall establish and
implement written procedures for maintaining records pertaining to the
acquisition and supply of, and complaints related to, medical gases.
(f) Records shall be retained for at least 3
years after supply to a patient or one year after the expiration date of the
medical gas, whichever is longer.
(g) Medical gases and equipment shall be secure
from unauthorized entry and have a system to detect or deter entry after hours
and provide protection against theft.
(h) The facility shall be maintained in a clean
and orderly condition, and only service animals shall be allowed.
(i) A policy and procedure shall be in place for:
(1) Recalls;
(2) Emergencies;
(3) Shipping and receiving;
(4) Returned goods; and
(5) Outdates.
(j) Records shall be readily available for review
by the board or its inspector during regular business hours.
Source. #12335, eff 7-22-17
CHAPTER Ph 700 STANDARDS OF
PRACTICE
REVISION NOTE:
Document #13398, effective 6-22-22,
adopted, repealed, readopted and renumbered, readopted with amendments, or
readopted with amendments and renumbered all of the rules in Chapter Ph 700
except for Ph 701.01 titled “Applicability”, which was not included in Document
#13398. The rule adopted by Document
#13338 was Ph 703.03 titled “Prescriptions.”
Amendments to the former Part Ph 703 titled “Records and Reports”,
renumbered as Part Ph 702, included the deletion of Ph 703.04 titled “Automated
Data Processing.” The adoption, the
deletion of Ph 703.04, and the repeals necessitated extensive renumbering of
the remaining, existing rules in Chapter Ph 700 as noted in the source notes
where the former rule numbers are indicated.
Document #13398 replaces all prior filings affecting rules in Chapter Ph
700 except for Ph 701.01.
The prior filings affecting the
deleted rule Ph 703.04 as noted above included the following documents:
#2118, eff 8-12-82
#2260, eff 1-5-83
#2914, eff
11-27-84
#4600, eff 8-1-89
#6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
#6181-B, eff
2-5-96, EXPIRED: 2-5-04
#8316, eff
3-26-05, EXPIRED: 3-26-13
#10903, eff 8-5-15
The former rules repealed by Document
#13398 included the following:
PART Ph 702 PHARMACY FACILITIES AND EQUIPMENT
Ph 702.01 titled “Area, Space and Fixtures”
Ph 702.02 titled “Temperature”
Ph 702.03 titled “Quarantine”
Ph 702.04 titled “Security”
Ph 702.05 titled “Limitations on Access”
Ph 702.06 titled “Minimum Drug Standards”
Ph 702.07 titled “Minimum Standard of Technical
Equipment and Stock”
PART Ph 704 DISPENSING OF DRUGS AND DEVICES
Ph 704.02 titled “Pre-signed Prescription Blanks”
Ph 704.03 titled “Transmission of Prescription Drug
Order by Prescriber”
Ph 704.10 titled “Out-of-State Prescriptions”
Ph 704.11 titled “Pharmacist-in-Charge/Corporate Entity
Requirements/Duties”
Ph 704.12 titled “Termination of Pharmacist-in-Charge
Notice”
Ph 704.13 titled “Termination of Pharmacist-in-Charge –
Inventory”
PART Ph 705 STORAGE OF DRUGS
Ph 705.01 titled “Prescription Drugs”
Ph 705.02 titled “Emergency Drug Kits for Long Term
Care Facilities/Specialized Care Facilities”
PART Ph 708 TERMINATION OF A PHARMACY OPERATION
Ph 708.01 titled “Notification of Closing”
Ph 708.02 titled “Disposition of Drugs/Records”
Ph 708.03 titled “Final Written Report
PART Ph 709 INSTITUTIONAL PRACTICES
Ph 709.01 titled “Definitions”
Ph 709.02 titled “Licensing and Practice Standards”
Ph 709.03 titled “Environment”
Ph 709.04 titled “Drug Security”
Ph 709.05 titled “Dispensing Practices”
Ph 709.06 titled “Access to the Pharmacy”
Ph 709.07 titled “Drug Control in Ambulatory Patient
Treatment Areas”
Ph 709.08 titled “Investigational Drugs”
Ph 709.09 titled “Purchase of Drugs”
#1639, eff 11-1-80
#2260, eff 1-5-83
#2914, eff
11-27-84
#4600, eff 8-1-89
#6094-B, INTERIM,
eff 9-21-95, EXPIRED: 1-19-96
#6181-B, eff
2-5-96, EXPIRED: 2-5-04
#8316, eff 3-26-05
#8572, eff 2-23-06
#10456, eff
11-1-13
#10903, eff 8-5-15
The prior filings affecting the
repealed rules Ph 704.02, Ph 704.03, and Ph 704.10 through Ph 704.13 in the
former Part Ph 704 as noted above included the following documents for all 6
rules except as noted:
#1639, eff 11-1-80
(Ph 704.02 and Ph 704.03 only)
#2260, eff 1-5-83
(Ph 704.02, Ph 704.03, and Ph 704.10 only)
#2914, eff
11-27-84 (Ph 704.02, Ph 704.03, and Ph 704.10 only)
#4600, eff 8-1-89
#6094-B, INTERIM,
eff 9-21-95, EXPIRED: 1-19-96
#6181-B, eff
2-5-96, EXPIRED: 2-5-04
#8316, eff
3-26-05, EXPIRED: 3-26-13 (Ph 704.03 did not expire)
#8572, eff 2-23-06
(Ph 704.03 only)
#10224, eff
11-7-12 (Ph 704.03 only)
#10457, eff
11-1-13 (Ph 704.11 only)
#10903, eff 8-5-15
#13015, EMERGENCY,
eff 4-7-20, EXPIRED: 10-4-20 (Ph 704.03(b)(4)d. only)
#1639, eff 11-1-80
#2260, eff 1-5-83
#2914, eff
11-27-84
#4600, eff 8-1-89
#6094-B, INTERIM,
eff 9-21-95, EXPIRED: 1-19-96
#6181-B, eff
2-5-96, EXPIRED: 2-5-04
#6933, eff 2-1-99
#8316, eff
3-26-05, EXPIRED: 3-26-13
#10903, eff
8-15-15
The prior filings affecting the
repealed rules in the former Part Ph 709 as noted above included the following
documents:
#2260, eff
01-05-83
#2914, eff
11-27-84
#4600, eff 8-1-89
#6094-B, INTERIM,
eff 9-21-95, EXPIRED: 1-19-96
#6181-B, eff
2-5-96, EXPIRED: 2-5-04
#6933, eff 2-1-99
#8316, eff 3-26-05
#8572, eff 2-23-06
#10225, eff
11-7-12
#10903, eff 8-5-15
PART Ph 701 REFERENCES AND DEFINITIONS
Ph 701.01 Applicability. The provisions of this chapter shall apply
to, and impose duties upon, all pharmacists, pharmacies, manufacturers, wholesalers and distributors holding
licenses issued by the board.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15
Ph 701.02 Definitions. Except where the context makes another
meaning manifest, the following words mean:
(a)
"Adulterated drug" means any drug:
(1) That is contaminated,
decomposed, deteriorated, sub‑potent, super‑potent, or otherwise
unsafe for administration to humans or other animals;
(2) Which has been manufactured,
composed, prepared, stored, or dispensed in such a manner which may cause it to
be contaminated, decomposed, deteriorated, sub‑potent, super‑potent,
or otherwise unsafe for administration to humans or other animals; and
(3) Which can be defined as an adulterated drug under the provisions of
RSA 146:4 or federal law.
(b)
"Device" means an instrument, apparatus, implement, machine,
contrivance, implant, or other similar or related article, including any
component part or accessory, which is required under federal law to bear the
label, "Caution: Federal or State
law requires dispensing by or on the order of a physician" or “Rx only”.
(c)
“Distributor” means a person or persons who supplies or facilitates the
supply of prescription drugs or devices to someone other than the patient,
including, but not limited to, manufacturers, repackagers, brokers and
wholesale drug distributors.
(d)
“Fit place to practice”
means that an employee can safely
complete professional and clinical duties and tasks in compliance with the
board’s rules and statutes because the facility’s permit holder has established
processes, policies, and procedures necessary to ensure safety.
(e)
"Institution" means a health care facility which provides
inpatient care and includes:
(1) Hospitals;
(2) Nursing homes;
(3) Extended care facilities;
(4) Residential care facilities;
(5) Infirmaries;
(6) Hospice house;
(7) Correctional facilities; and
(8) Clinics.
(f)
"Institutional pharmacy" means an area in an institution where
drugs are stored, manufactured, compounded, dispensed, or issued to other areas
or departments of the institution.
(g)
"Misbranded drug" means a drug:
(1) Whose label misrepresents the contents or is
misleading;
(2) Dispensed
by prescription with a label that does not comply with the provisions of
RSA 318 or RSA 318‑B; and
(3) Which can be defined as a misbranded drug
under the provisions of RSA 146 or federal law.
(h) “Permit
holder” means a person or entity to whom a license or permit has been issued
under the provisions of RSA 318 and RSA 318-B for the purpose of operating a
pharmacy.
(i)
"Prescriber" means a practitioner, duly authorized by statute,
who issues a drug order or prescription.
(j)
“Prescription” means a verbal, telephonic, written, or electronically
transmitted order for drugs, medicines, and devices by a practitioner licensed
in the United States, to be compounded and dispensed by licensed pharmacists in
a duly registered pharmacy.
(k)
"Principal" means an officer, director, or primary stockholder
of a business entity or corporation.
(l)
"Professional corporation" as used in these rules means a
corporation organized under RSA 294-A for the purpose of providing professional
services in the field of medicine, dentistry, veterinary, podiatry, pharmacy,
or any other profession in which individual practitioners can lawfully possess,
dispense, or distribute prescription drugs.
(m) “Professional judgement” means the
application of a combination of professional knowledge and experience to derive
a resolution within standards of care, ethics, and objectives.
(n)
“Scanned prescription” means the digital image of a prescription or
medication order scanned into the data processing system.
(o)
“Signature” means:
(1) The handwritten name of an
individual affixed by the hand of that individual to a document;
(2) An electronic sound, symbol,
or process attached to or logically associated with a record and executed or
adopted by a person with the intent to sign a document or record; or
(3) An electronic signature.
(p)
"Traditional physician‑pharmacist‑patient
relationship" means a situation whereby the pharmacist knows either the
physician, the patient, or both, and can readily and easily check on factors
concerning the prescription.
(q)
"Unit-dose" means a single-unit container that is designed to
hold a quantity of drug product intended for administration as a single dose
and labeled with the identity, quantity,
and strength, name of the manufacturer, lot number, and expiration date of the drug product.
(r)
"Unprofessional conduct" means conduct and practices which are
hostile to the protection of public health, safety and welfare and includes:
(1) Knowingly engaging in any activity which
violates state and federal statutes, regulations and rules governing the
practice of pharmacy;
(2) Knowingly dispensing an outdated product;
(3) Knowingly charging for more dosage units than
are actually dispensed;
(4) Knowingly altering prescriptions or other
records which the law requires the pharmacy or pharmacist to maintain;
(5) Knowingly dispensing medication without
proper authorization or prescription;
(6) Defrauding any persons or government agency
receiving pharmacy services;
(7) Placing a signature on any affidavit
pertaining to any phase of the practice of pharmacy which the pharmacist knows
to contain false information;
(8) Not adhering to the written policy and
procedures of the institution; or
(9) Failure to exercise or implement professional
judgement or corresponding responsibility with regard to the practice of
pharmacy.
(s)
"Wholesale drug distribution" means distribution of
prescription drugs other than to the patient, including, but not limited to
distribution by manufacturers, repackers, own label distributors, jobbers, and
wholesale drug distributors.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; amd by #7535, eff 8-1-01; paragraph (a) EXPIRED: 2-5-04; amd by #8316,
eff 3-26-05; amd by #8572, eff 2-23-06; paragraphs (b), (d)-(m), and (p)-(s)
EXPIRED: 2-1-07; paragraph (o) EXPIRED: 8-1-09; paragraph (a) EXPIRED: 3-26-13;
paragraphs (c) and (n) EXPIRED: 2-23-14
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(see Revision Note at chapter heading for Ph 700)
Ph 701.03 References.
(a)
Persons subject to these rules shall comply with the following
regulations and statutes as cited:
(1) RSA 146, Purity and Branding of Foods and
Drugs;
(2) RSA 318, Pharmacists and Pharmacies;
(3) RSA 318-B, the New Hampshire Controlled Drug
Act;
(4) 21 USC Sections 300 through 369, the Federal
Food, Drug, and Cosmetic Act; and
(5) 21 CFR 1300 to end.
(b)
Those institutional pharmacies subject to Ph 2300 shall not be subject
to the Ph 700 rules except where specifically indicated.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(see Revision Note at chapter heading for Ph 700)
PART Ph 702 RECORDS AND REPORTS
Ph 702.01 Recordkeeping Requirements.
(a)
The requirements of Ph 702 shall be in addition to all record keeping
and reporting requirements contained in all federal and state rules and
regulations.
(b)
Hard copies of prescription records and reports shall not be required to be maintained if they can be
reproduced on demand with the exception of Schedule II – V controlled substance
prescriptions not presented in electronic format.
(c)
Hardcopy prescriptions for Schedule II – V controlled substances shall
be kept on file for 4 years.
(d)
Documentation of the fact that the refill information entered into the
computer each time a pharmacist refills an original prescription order,
including refill orders from a schedule III, IV, or V controlled substances is
correct shall be provided by:
(1) A hard copy printout of each day’s-controlled
substance prescription order refill data which shall be verified, dated, and
signed by each pharmacist who refilled such prescription order; or
(2) In lieu of such a printout, the pharmacy
shall maintain a bound logbook, or separate file, in which each individual
pharmacist involved in such dispensing shall sign a statement each day,
attesting to the fact that the refill information entered into the computer
that day has been reviewed by him and is correct as shown.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by 13398, eff 6-22-22
(formerly Ph 703.01)
Ph 702.02 Prepackaging of Drugs.
(a)
Drugs shall be prepackaged in quantities suitable for internal
distribution only by a pharmacist, licensed advanced pharmacy technician, or by
supportive personnel under the direct supervision of a pharmacist.
(b)
The label of a prepackaged unit shall indicate the:
(1) Name and strength of the drug and name of the
manufacturer, manufacturers lot number, or distributor;
(2) Assigned in‑house, quality control lot
number;
(3) Expiration date; and
(4) Quantity of the drug, if the quantity is
greater than one.
(c)
The pharmacist or licensed advanced pharmacy technician who prepackages
or supervises prepackaging shall maintain a written or electronic record that contains at least the following
information:
(1) Name of the drug, strength, and dosage form;
(2) Assigned in-house, quality control lot
number;
(3) Manufacturer or distributor;
(4) Manufacturer's lot number;
(5) Expiration date;
(6) Quantity per prepackaged unit;
(7) Number of prepackaged units;
(8) Date packaged;
(9) Identifier of the prepacker;
and
(10) Signature of the responsible pharmacist or
licensed advanced pharmacy technician.
(d)
Stock packages, repackaged units, and control records shall be
quarantined together until checked/released by the pharmacist.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff
8-5-15; ss by 13398, eff 6-22-22 (formerly Ph 703.02)
Ph 702.03 Controlled Drug Losses.
(a)
The pharmacist on duty shall report to the board by completing, and submitting, a New Hampshire “Controlled Drug Loss Form”, revised 5/2022, found online at https://www.oplc.nh.gov/state-pharmacy and submitting to the board through the mail to
the address in Ph 103.03(a) or by email to pharmacy.compliance@oplc.nh.gov any theft or
significant loss described in Ph 702.03(e) of controlled substances within one
business day.
(b)
All instances of diversion shall be reported within one business day.
(c) In addition to the initial
report of loss required per section (a) above, the pharmacist who discovered
the loss shall submit a final report on the loss by completing, and submitting, a New Hampshire
“Controlled Drug Loss Form”, revised
5/2022 found online at
https://www.oplc.nh.gov/state-pharmacy and submitting to the board through the mail to the address in Ph 103.03(a)
or by email to pharmacy.compliance@oplc.nh.gov as soon as the
investigation into the loss is complete but no later than 30 days after the
discovery of the loss.
(d)
A pharmacy shall keep a perpetual inventory for all Schedule II drugs
and actual counts shall be verified monthly. The inventory reports shall be
maintained for a minimum of 2 years and be readily available upon board
inspection or request.
(e) A pharmacy shall consider a
controlled drug loss to be significant when:
(1) The percentage of dosage
units of a specific drug exceeds 2% of monthly dispensing volume; or
(2) Fifteen or more dosage
units are not accounted for.
(f)
The written report referenced in (a) shall contain at least the
following:
(1) Date of discovery;
(2) The identity of the person
making the discovery;
(3) The name and location of
the pharmacy from which the drug is missing;
(4) Name, strength, dosage
form, NDC and quantity of the missing drug(s); and
(5) The cause of the controlled
drug loss as determined by the investigation.
(g) After 3 significant losses described in Ph
702.03(e) within a 12-month period and after
investigation, the pharmacist in charge and the permit holder shall present to
the board an action plan to remedy the
issue. The board shall require, if
necessary, additional security measures to address the issue. Failure to do so shall be subject to disciplinary action as
provided in RSA 318:29.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by 13398, eff 6-22-22
(formerly Ph 703.03)
Ph 702.04 Federal DEA #222
Order Forms. All used DEA #222 order
forms or any successor forms shall be maintained on the premises to which the
forms and the corresponding DEA permit number were issued. In the case of
on-line ordering of CII drugs, all records of such shall be maintained on said
premises and be readily retrievable.
Such records shall meet the requirements of federal laws and regulations
and shall be maintained for a period of not less than 2 years.
Source. #2118, eff 8-12-82: ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by 13398, eff 6-32-22
(formerly Ph 703.05)
Ph 702.05 Inspection Report. The current compliance inspection report of
the licensed location, conducted by the board, shall be kept on file in the
prescription department.
Source. #2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; ss by #6933, eff 2-1-99,
EXPIRED: 2-1-07
New. #10066, eff 12-28-11; ss by #10903, eff
8-5-15 (from Ph 703.06) ; ss by 13398, eff 6-22-22 (formerly Ph 703.06)
PART Ph 703 DISPENSING OF DRUGS AND DEVICES
Ph
703.01 Presence of Pharmacists.
(a) No pharmacist shall work more than 8 hours
without a rest break of 30 minutes.
Breaks shall be scheduled as close as possible to the same time each day
so that patients may become familiar with the approximate break times.
(b) The permit holder shall develop a written
break policy and procedure that shall
be available upon inspection or board request.
Failure to follow the policy shall be subject to disciplinary action as provided in RSA
318:29.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; ss by #6933, eff 2-1-99;
ss by #8572, eff 2-23-06; ss by#10459, eff 11-1-13; ss by #10903, eff 8-5-15;
ss by #11189, eff 9-23-16; ss by #13398, eff 6-22-22 (formerly Ph 704.01)
Ph 703.02 Schedule V Controlled Substances. All cough syrups containing codeine shall
require a valid prescription.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 704.05)
Ph 703.03 Prescriptions.
(a)
All schedule III through V controlled substance prescription drug
orders, as described in RSA 318-B:1-b, and transmitted by facsimile or as an
electronic prescription, shall include:
(1) The name and address of the patient;
(2) The name, strength, and quantity of the drug
prescribed;
(3) Any directions specified by the prescribing
practitioner;
(4) The full name of the prescribing practitioner
which shall be printed, rubber stamped, or typewritten above or below his or
her handwritten signature;
(5) The address of the prescribing practitioner;
(6) The federal drug enforcement administration
(DEA) number assigned to the prescribing practitioner; and
(7) The date the prescription was ordered.
(b)
A facsimile prescription for a schedule II controlled substance shall
not be accepted as an original written prescription except in circumstances
when:
(1) A prescription prepared in accordance with
RSA 318-B:9, III and IV, and issued for a schedule II substance, as described
in RSA 318-B:1-b, to be compounded for the direct administration, to a patient in a private residence,
long-term care facility, or hospice setting, by parenteral, intravenous,
intramuscular, subcutaneous, oral administration, or intraspinal
infusion. The printed copy of the
transmission shall serve as the original written prescription and shall be
maintained in accordance with the provisions of RSA 318-B:9, I; and
(2) A prescription prepared in accordance with
RSA 318-B:9, III and IV, and issued for a schedule II substance, as described
in RSA 318-B:1-b, for a resident of a long-term care facility or patient
enrolling in hospice care program. Such
prescriptions may be transmitted by the practitioner or the practitioner’s
designated agent, to the dispensing pharmacy.
The printed copy of the transmission shall serve as the original written
prescription and shall be maintained in accordance with the provisions of RSA
318-B:9, I; and
(c)
The pharmacist shall exercise professional judgment regarding the
accuracy and authenticity of the transmitted prescription drug order which
shall be consistent with existing federal or state laws and rules.
(d)
For controlled substances in schedules II, III, IV, or V, as described in RSA 318-B:1-b,
a pharmacy may receive an electronically transmitted drug order from the
prescriber for filling provided that it is transmitted in accordance with
federal law with an electronic signature meeting security requirements required
by the Drug Enforcement Agency (DEA) for electronic prescriptions.
(e) All prescriptions dispensed by a
health care provider or pharmacy containing an opiate shall:
(1) Affix an orange sticker to the cap or
dispensing device with the word “opioid” in easily legible font;
(2) Have a warning label that states “Risk of
Addiction or Overdose”; and
(3) Provide the person with handout provided by
the governor’s commission on alcohol and drug abuse, prevention, treatment, and
recovery on guidance for associated risks of opioid use and how to mitigate
them.
(f)
Pharmacists or a pharmacy that dispenses a drug containing an opioid
that is to be administered to a patient treated in a health care facility
required to be licensed under RSA 151 shall not be subject to the provisions of
(e) above.
(g)
Failure to comply with Ph 703.02 shall result in disciplinary action by
the board.
Source. #13398, eff 6-22-22 (see Revision Note at
chapter heading for Ph 700)
(a) The
transfer of controlled drug prescriptions shall be communicated between 2
licensed pharmacists, or a pharmacist and intern;
(b) The
transfer of non-controlled prescriptions shall be communicated between 2
licensed pharmacists, licensed advanced pharmacy technicians, certified
pharmacy technicians, or
pharmacy interns;
(c) The transferring pharmacist, licensed
advanced pharmacy technician, certified pharmacy technician, or pharmacy intern shall notate in
the computer record the following:
(1) That a copy
has been issued, the date of transfer, and the name of the individual
transferring the prescription; and
(2) The name, address, phone number and DEA number of
the pharmacy to which the prescription was transferred and the full name of the
agent receiving the prescription information.
(d) When a prescription is transferred, no
further refills shall be issued by the transferring pharmacy;
(e) The receiving agent of the transferred
prescription information shall:
(1) Include the
word “transfer” on the face of the transferred prescription; and
(2) Provide all
information required to be on the prescription including the:
a. Patient's
name and address;
b. Doctor's
name and address;
c. Date of
issuance of the original prescription and date of transfer;
d. Number of
valid refills remaining and date of last refill;
e. Pharmacy name, address, and original prescription
number from which the prescription information was transferred;
f. Full name of
the transferor pharmacist, certified pharmacy technician, licensed advanced
pharmacy technician, or pharmacy intern; and
g. DEA
registration number of the transferor pharmacy for controlled substances.
(f) The pharmacist shall maintain both the
original and transferred prescription as if they were original prescriptions;
(g) A transferred prescription may be refilled,
without limitation, up to the number of remaining refills, as originally
authorized, or up to one year from the date of original issue, whichever shall
occur first;
(h) The transfer of original prescription drug
order information for controlled substances listed in Schedule III, IV, or V shall conform to the
requirements of 21 CFR 1306.26 and shall be permissible between pharmacies on a
one-time basis and shall not be further transferred;
(i) Two or more pharmacies may establish and use
a common electronic file to maintain required dispensing information. Pharmacies using such a common electronic
file shall not be required to physically transfer prescriptions or information
for dispensing purposes between or among pharmacies participating in the same
common prescription file, except that any such common file shall contain
complete and adequate records of such prescription and the date and location of
each refill dispensed, and
provisions shall be made to assure that the number of authorized refills shall
not be exceeded; and
(j) New or on-hold
prescription orders for prescription drugs may be transferred to another
pharmacy provided that a copy of the original prescription or electronic
transmission is provided to the pharmacy accepting the transfer. Transfer of controlled substance
prescriptions shall be done in accordance with current federal
Drug Enforcement Administration (DEA) guidelines located in 21 CFR 1306.25.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by #8572, eff 2-23-06;
ss by #10458, eff 11-1-13; ss by #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 704.04) (see Revision Note at chapter heading for Ph 700)
Ph 703.05 Drug Product Selection.
(a)
Unless instructed otherwise by the person receiving the drug pursuant to
the prescription, a pharmacist filling a prescription for a drug product
prescribed by its trade or brand name may select a therapeutically equivalent
drug product with the same established name, active ingredient, strength,
quantity, and dosage form as the
drug product identified in the prescription.
(b)
Therapeutically equivalent drugs shall include only those drug products
listed in "Approved Prescription Drug Products with Therapeutic
Equivalence Evaluations" Published by the United States Department of
Health and Human Services, according to RSA 146-B:2, I, or any written
notification or confirmation from the federal Food and Drug Administration
(FDA) that a drug product is a therapeutically equivalent drug product.
(c)
The pharmacist shall not
select an equivalent drug product:
(1) If the prescriber handwrites “medically
necessary” on the written prescription;
(2) If when ordering a prescription orally, the
prescriber specifies that the prescribed drug is medically necessary; or
(3) If the prescription is electronically
transmitted, the prescriber includes a statement on the face of the
prescription indicating medically necessary.
(d)
The pharmacist shall not select an equivalent drug product unless its
price to the purchaser or payor is
less than the price of the prescribed drug product.
(e)
Unless the prescriber instructs otherwise, the label for every drug
product dispensed shall include the product's trade or brand name, if any, or
its established generic name and the name of the manufacturer, packer or
distributor, using abbreviations such as the National Drug Code (NDC) number if
necessary. In the interest of public
health and safety, the pharmacist may, when dispensing a generic drug, include
the brand name on the prescription label following the generic name. The
brand name, however, shall be preceded or followed with the word
"sub", indicating substituted for, or "I.C.", indicating
interchanged for or “generic for”.
(f)
A pharmacist shall adapt drugs:
(1) By changing the quantity of medication
prescribed if:
a. The prescribed quantity or package size is
not commercially available;
b. The change in quantity is related to a change
in dosage form, strength, or therapeutic interchange;
c. The change is intended to dispense up to the
total amount authorized by the prescriber including refills; or
d. The change extends a maintenance drug for the
limited quantity necessary to coordinate a patient’s refills in a medication
synchronization program;
(2) By changing dosage form of the prescription
if it is in the best interest of patient care, so long as the prescriber’s
directions are also modified to equate to an equivalent amount of drug
dispensed as prescribed;
(3) By completing missing information on a
prescription if there is evidence to support the change; and
(4) The adaptation is documented in the patient’s
record.
(g)
A pharmacist may perform therapeutic substitutions if:
(1) The pharmacist filling a prescription for a
specific drug substitutes a drug in the same therapeutic class, the patient
agrees to the substitution, and the substitution is made to replace a drug that
is on back order ensures formulary compliance with the patient’s health
insurance plan or in the case of an uninsured patient to the lower cost drug
while maintaining safety; or
(2) The pharmacist is used by a long-term-care
facility and the therapeutic interchange or a therapeutically equivalent
selection for a patient, during the patient’s stay at the facility, has been
approved for the patient in accordance with written guidelines and procedures
developed by the facility that in conjunction with the pharmacist and is
current and readily available to the pharmacist at the pharmacy.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; amd by #8572, eff 2-23-06;
paragraphs (a), (d), (e), & (g) EXPIRED: 3-26-13; paragraphs (b), (c), and
(f) EXPIRED: 2-23-14
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 704.06) (see Revision Note at chapter heading for Ph 700)
Ph 703.06 Return of Drugs and Devices.
(a)
Except as provided in (b) below, no drug, prescription, device, sickroom
supply, or item of personal
hygiene which has left control of the pharmacist or pharmacy and is returned to
the pharmacy shall be resold or re-dispensed after such item has been taken
from the premises by the patient or the patient’s representative.
(b)
Exceptions to (a) above shall include:
(1) Orthopedic appliances;
(2) Crutches;
(3) Canes;
(4) Wheelchairs;
(5) Hospital beds;
(6) Bed rails;
(7) Trapezes;
(8) Other durable equipment that can be properly
sanitized; and
(9) Medications dispensed in unit-dose packaging
to institutionalized patients.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraph (b) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; paragraph (a)
EXPIRED: 2-1-07; paragraph (b) EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 704.07) (see Revision Note at chapter heading for Ph 700)
Ph 703.07 Prescription Pick-up and Delivery.
(a) No person licensed under the provisions of
RSA 318, shall enter into or participate in any arrangement or agreement
whereby prescriptions may be left at, picked up from, accepted by, or delivered
to any store, shop or location not licensed as a pharmacy, except as outlined
in Ph 703.06(b).
(b) Identification requirements for schedule
medication drop off and pick up, excluding delivered prescriptions, shall
include receipt of a photo identification (ID), at the time the prescription is
picked up, for all schedule II medications, and the receipt of the photo ID
shall be documented in the patients record.
(c) Mail order pharmacies dispensing new schedule
II medications to the patient shall comply with the requirements set forth in
Ph 704.03 patient counseling.
(d) This section shall not prohibit a licensee
from picking up prescriptions or delivering prescribed medications at any
location requested by the patient, by means of mail, an employee, a currier, or
by use of a common carrier. A pharmacy
that delivers prescription orders by one or more alternate methods shall have
policies and procedures to ensure patient confidentiality, prescription order
accountability, and proper storage of prescription orders during
transportation.
(e) In situations where it is in the best
interest of the patient due to behavioral health issues or homelessness a
licensee may deliver the prescriptions to an authorized party for distribution
to the patient.
(f) Drugs with special handling or storage
requirements that will be administered by the practitioner, such as but not
limited to radio pharmaceuticals or frozen immunizations, may be delivered
directly to the practitioner’s office
(g) A signature,
or electronic signature, log must be maintained by the pharmacy. A signature or electronic signature is not
required to be obtained for delivered prescriptions.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 704.08) (see Revision Note at chapter heading for Ph 700)
Source. #1639, eff l1-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 704.09) (see Revision Note at chapter heading for Ph 700)
Ph 703.09 Prescription Refill Limitations.
(a)
Prescriptions bearing "PRN", "Ad lib", or other
similar prescription refill designation permitting the pharmacist to refill the
prescription as needed by the patient, shall be refilled only in keeping with
the number of doses ordered and according to the directions for use, and in no
instance shall such prescription be refilled beyond one year from the date of
issue. If additional medication is
needed thereafter, the original prescription shall be voided and a new
prescription obtained.
(b) No prescription containing either specific or
"PRN" refill authorization shall be refilled when the pharmacist has
knowledge that the prescribing practitioner ceases to practice due to:
(1) License suspension or revocation;
(2) No longer maintaining a valid license;
(3) Prescribing limitations placed on a
practitioner's license by any state or federal licensing agency which impact on
certain previously refillable prescriptions; or
(4) Death.
(c)
Notwithstanding (a) and (b) above, the pharmacist may dispense an
additional refill supply according to the provisions of Ph 703.09.
Source. #2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a) and (b) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05;
paragraph (c) EXPIRED: 2-1-07; paragraphs (a) and (b) EXPIRED: 3-26-13
New. #10685, EMERGENCY, eff 10-6-14, EXPIRED:
4-6-15
New. #10903, eff
8-5-15;
ss by #13398, eff 6-22-22 (formerly Ph 704.14) (see Revision Note at chapter
heading for Ph 700)
Ph 703.10 Prescription Refill - Interim Supply. A pharmacist may refill a prescription drug order, including controlled substances
listed in Schedules III, IV, and
V, without the authorization of the prescribing practitioner, provided that:
(a)
A failure to refill the prescription might result in an interruption of
a therapeutic regimen or create patient suffering;
(b)
The pharmacist is unable to contact the practitioner due to:
(1) A natural or man-made disaster has occurred
which prohibits the pharmacist from being able to contact the practitioner; or
(2) The practitioner’s office being closed
without a practitioner on call;
(c)
It is necessary to synchronize the patient’s medications as referenced
in RSA 415:27 and RSA 420-J:19;
(d)
The quantity of prescription drug dispensed does not exceed a 90 days
supply for maintenance medications, unless federal law states otherwise,
excluding filling prescriptions for controlled substances listed in Schedule
III, which shall comply with NH RSA 318-B:9, IV;
(e)
The pharmacist informs the patient or the patient's agent at the time of
dispensing that the interim supply shall be final and that authorization by the
practitioner shall be required for future refills;
(f)
The pharmacist shall inform the prescribing practitioner of the limited
emergency supply, provided to the patient, at the earliest reasonable time; and
(g) The pharmacist exercises professional
judgement in refilling the prescription drug order.
Source. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a), (b), (d), and (e) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; intro. paragraph and (c) EXPIRED: 2-1-07; paragraphs (a), (b), (d),
and (e) EXPIRED: 3-26-13
New. #10903, eff 8-5-15; amd by #13007, EMERGENCY
RULE, eff 3-20-20; amd by #13043, EMERGENCY RULE, eff 5-20-20, EXPIRED 11-16-20
(in intro. And paragraph (c)); ss by #13398, eff 6-22-22 (formerly Ph 704.15)
(see Revision Note at chapter heading for Ph 700)
Ph 703.11 Acts Prohibited. Splitting fees,
making rebates, or sharing money received for pharmaceutical services, or the
donation of or the use of equipment with other health practitioners or with
health institutions providing patient care shall be deemed by the board to be
contrary to the best interests of the patient, and shall therefore be
prohibited.
Source. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a), (b), (d), and (e) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; intro. paragraph and (c) EXPIRED: 2-1-07; paragraphs (a), (b), (d),
and (e) EXPIRED: 3-26-13
New. #10903, eff 8-5-15; amd by #13007, EMERGENCY
RULE, eff 3-20-20; amd by #13043, EMERGENCY RULE, eff 5-20-20, EXPIRED 11-16-20
(in intro. and paragraph (c)); ss by #13398, eff 6-22-22 (formerly Ph 704.16)
(see Revision Note at chapter heading for Ph 700)
PART Ph 704 PHARMACEUTICAL CARE STANDARDS
Ph 704.01 Patient Records.
(a)
A patient record system shall be maintained by all pharmacies for
patients for whom prescriptions are dispensed.
The patient record system shall provide for the immediate retrieval of
information necessary for the dispensing pharmacist to identify previously
dispensed drugs at the time a prescription is presented for dispensing.
(b)
A reasonable effort shall be made to obtain, record, and maintain the
following information:
(1) The full name of the patient for whom the
drug is intended;
(2) The address and telephone number of the
patient;
(3) The patient's date of birth;
(4) The patient's gender;
(5) A list of all prescription drug orders;
(6) Documentation relevant to the individual's
drug therapy, including any other information peculiar to the specific patient
or drug.
(c)
The pharmacist or support personnel shall make a reasonable effort to
obtain from the patient or the patient's agent, and record, any known:
(1) Allergies;
(2) Drug reactions; and
(3) Usage of other drugs, including
over-the-counter drugs, currently being used by the patient.
Source. #5552 INTERIM eff 1-8-93, EXPIRES 5-8-93; ss
by #5622, eff 5-8-93; ss by #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 706.01) (see Revision Note at chapter heading for Ph 700)
Ph 704.02 Prospective Drug Review.
(a)
A pharmacist shall review the patient record and each prescription
presented for dispensing for purposes of identifying:
(1) Over-utilization or under-utilization;
(2) Therapeutic duplication;
(3) Drug-disease contraindication;
(4) Drug-drug interactions;
(5) Incorrect drug dosage or duration of drug
treatment;
(6) Drug-allergy interactions; and
(7) Clinical abuse or misuse.
(b)
Upon recognizing any of the above, the pharmacist shall take appropriate
steps to avoid or resolve the problem which might include consultation with the
prescriber.
Source. #5552 INTERIM eff 1-8-93, EXPIRES 5-8-93; ss
by #5622, eff 5-8-93; ss by #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 706.02) (see Revision Note at chapter heading for Ph 700)
Ph 704.03 Patient Counseling.
(a)
Patient counseling shall be appropriate based on the pharmacist’s
professional and clinical judgement according to current standards of practice.
(b)
A pharmacist shall not be required to counsel a patient or agent when
the patient or agent refuses such consultation.
However, failure to document the patient's refusal of counseling shall
imply that counseling was provided.
Source. #5552 INTERIM eff 1-8-93, EXPIRES 5-8-93; ss
by #5622, eff 5-8-93; ss by #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 706.03) (see Revision Note at chapter heading for Ph 700)
PART Ph 705 DISPOSAL AND DESTRUCTION OF CONTROLLED
DRUGS
Ph 705.01 Controlled Drug Destruction. Any person authorized to possess controlled
drugs and desiring to dispose of such drugs may request destruction of the
drugs by the board or request an authorization from the board to destroy such
drugs.
Source. #4600, eff 8-1-89; ss by #6094-B, INTERIM,
eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05; ss by #8572, eff 2-23-06,
EXPIRED: 2-23-14
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 707.01) (see Revision Note at chapter heading for Ph 700)
Ph 705.02 Request for Destruction.
(a)
A request to destroy controlled drugs shall be in writing and signed by
a duly authorized person as defined in (b) below. The itemized written request shall be
conveyed to the board office and the destruction process shall not proceed
until the authorization is received by the person who made the request.
(b)
Personnel authorized to sign a request for controlled drug destruction
shall include:
(1) Pharmacist-in-charge, as defined in RSA
318:1, X, practitioners or their designated agents;
(2) Administrators of health care institutions or
their designated agent or agents;
(3) Agents of the superior court;
(4) County attorneys;
(5) Director, New Hampshire state police;
(6) Chiefs of local police departments; and
(7) Director, New Hampshire division of public
health services or his or her
designated agent(s).
(c) The written request shall not be required
when a consultant pharmacist, acting as an agent of the pharmacy board,
destroys controlled drugs in a licensed long-term care or specialized care
facility.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraph (a), paragraph (b) intro., subparagraphs (b)(2)-(b)(7), and
paragraph (c) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; amd by #8572, eff
2-23-06; paragraphs (b)(2)-(b)(6) EXPIRED: 3-26-13; paragraphs (a), (b) intro.,
(b)(1), (b)(7), and (c) EXPIRED: 2-23-14
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 707.02) (see Revision Note at chapter heading for Ph 700)
Ph 705.03 Board Authorized Controlled Drug
Destruction.
(a)
A consultant pharmacist to a nursing home, group home, or assisted living facility shall be
designated an agent of the pharmacy board for the sole purpose of destroying
controlled drugs at the licensed home or homes for which he or she serves as
consultant by filing a written request at the board office, identified in Ph
103.03. The written request shall be on
the facility’s letterhead, shall identify the pharmacist as the home's
consultant pharmacist, and shall be signed by both the administrator of the
facility and the consultant pharmacist.
(b)
Once authorization is obtained:
(1) A record of the controlled drugs destroyed
shall be made on the “consultant’s Record of Drugs Destroyed” revised 5/2022
and obtained at the board office, identified in Ph 103.03; and
(2) Copies of form the “Consultant’s Record of
Drugs Destroyed” shall be distributed as follows:
a. The original shall be sent to the board
office;
b. A copy shall be maintained on the premises
where the destruction occurred for a period of 4 years; and
c. A copy shall be retained by the consultant
pharmacist or agent making the destruction.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (c) and (d) EXPIRED: 2-5-04; amd by #8316, eff 3-26-05; amd
by #8572, eff 2-23-06; paragraph (a) EXPIRED: 2-1-07; paragraph (b)-(f)
EXPIRED: 2-23-14
New. #10903, eff 8-5-15; amd by #13016, EMERGENCY
RULE, eff 4-7-20, EXPIRED 10-4-20 (in paragraph (c)); ss by #13398, eff 6-22-22
(formerly Ph 707.03) (see Revision Note at chapter heading for Ph 700)
Ph 705.04 Controlled Drug Destruction by the Board
of Pharmacy.
(a)
The destruction of controlled drugs by the board shall occur on the
premises of the practitioner, institution, or agency requesting the
destruction. Destruction shall be carried out by any person so designated as
the authorized agent of the board provided that such agent as well as the
person requesting destruction or his or her designee are present during the
entire destruction process.
(b)
Witnesses may include:
(1) The practitioner or practitioner’s agent,
including a pharmacist;
(2) The administrator or assistant administrator;
and
(3) The director of nursing, nursing supervisor,
or charge nurse.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; amd by #13016, EMERGENCY
RULE, eff 4-7-20, EXPIRED 10-4-20 (in paragraph (a)); ss by #13398, eff 6-22-22
(formerly Ph 707.04) (see Revision Note at chapter heading for Ph 700)
Ph 705.05 Record of Controlled Drug Destruction.
(a) A record of the drugs destroyed shall be made
on federal form DEA-4l, "Registrant's Inventory of Drugs Surrendered"
in accordance with 21 CFR 1307.21, 22.
This form may be obtained from the board office, identified in Ph
103.03, or from an office of the Drug Enforcement Administration.
(b) The data recorded on form DEA‑41 shall
include at least the:
(1) Name,
strength, and quantity of the drugs destroyed;
(2) Date, time,
and place of destruction;
(3) Manner of
destruction; and
(4) Signature and title of persons destroying and
witnessing destruction of the controlled drugs.
(c) Copies of the form required under federal law
21CFR, 317, shall be distributed as follows:
(1) The
original shall be maintained at the board office, identified in Ph 103.03; and
(2) A copy
shall be retained on the premises of the practitioner, agency, court, or person
requesting the destruction.
(d) A copy of the record of those drugs destroyed
shall be maintained on the premises where the destruction occurred for a period
of 2 years.
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff
2-1-99; paragraphs (a), (b), and (d) EXPIRED: 2-5-04; amd by #8316, eff
3-26-05; paragraph (c) EXPIRED: 2-1-07; paragraphs (a), (b), and (d) EXPIRED:
3-26-13
New. #10903, eff 8-5-15 ss by #13398, eff 6-22-22
(formerly Ph 707.05) (see Revision Note at chapter heading for Ph 700)
Source. #1639, eff 11-1-80; ss by #2260, eff 1-5-83;
ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff
9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15 ss by #13398, eff 6-22-22
(formerly Ph 707.06) (see Revision Note at chapter heading for Ph 700)
PART Ph 706 ADMINISTRATIVE
FINES
Ph
706.01 Liability for Administrative
Fines. Persons subject to the
disciplinary authority of the board and other persons subject to administrative
fines or penalties under RSA 318:29, IV shall, at the discretion of the board, after
notice and an opportunity to be heard, be assessed fines and/or penalties as
authorized under RSA 318:29, IV.
Source. #2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96
New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04
New. #8316, eff 3-26-05, EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 710.01) (see Revision Note at chapter heading for Ph 700)
Ph 706.02 Severity of Fine.
(a)
The decision to impose a fine and the amount of such fine shall depend
on:
(1) The severity of harm to the public posed by
the violation(s);
(2) The number of concurrent and/or repeated
violations; and
(3) The frequency of violations committed by the
particular licensee, permit holder, or other person.
(b)
When no violation of the same type has occurred within the 5 years
preceding the board's notice to the respondent, the fine assessed shall not
exceed $1,000 per violation upon the licensee and/or $2,000 per violation upon
the permit holder.
(c)
When a single disciplinary infraction of the same type has occurred
within the 5 years preceding the board's notice to the licensee, the fine
assessed shall not exceed $2,000 per violation upon the licensee and/or $3,000
per violation upon the permit holder.
(d)
When more than one disciplinary infraction of the same type has occurred
within the 5 years preceding the board's notice to the licensee, the fine
assessed shall not exceed $3,000 per violation upon the licensee and/or $5,000
per violation upon the permit holder.
(e)
In the case of continuing violations, a separate fine shall be assessed
for each day the violation continues, but the total amount of the fine and the
licensee's promptness and cooperativeness in ceasing the prohibited conduct in
question shall be considered in assessing the daily fines.
(f)
In all cases, the board shall consider:
(1) The nature of the offense;
(2) The purpose of the rule or statute violated;
(3) The licensee's state of mind at the time the
offense occurred;
(4) The potential harm to the public health;
(5) The deterrent effect upon other
practitioners;
(6) The licensee's willingness to cooperate with
the board;
(7) The cost to the board of any formal
disciplinary hearings which were necessary;
(8) The licensee's acknowledgment of his or her
wrongdoing; and
(9) The nature of any other disciplinary
sanctions imposed as a result of the offense in question.
Source. #2260, eff 1-5-83; ss by #2914, eff 11-27-84;
ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED: 1-19-96
New. #6181-B, eff 2-5-96; amd by #6933, eff 2-1-99;
paragraphs (a), (b), (c) intro., (c)(1)-(2), and (e) EXPIRED: 2-5-04; amd by
#8316, eff 3-26-05; paragraphs (c)(3) and (d) EXPIRED: 2-1-07; paragraphs (a),
(b), (c) intro., (c)(1)-(2), and (e) EXPIRED: 3-26-13
New. #10903, eff 8-5-15; ss by #13398, eff 6-22-22
(formerly Ph 710.02) (see Revision Note at chapter heading for Ph 700)
CHAPTER
Ph 800 PHARMACY TECHNICIANS
Statutory
Authority: RSA 318:5-a, X, XI
PART Ph 801 PURPOSE AND SCOPE
Ph 801.01 Purpose and Scope. The provisions of this chapter shall apply
to, and impose duties upon, all pharmacy technicians holding registrations or
certifications issued by the board.
Source. #7535, eff 7-25-01, EXPIRED: 7-25-09
New. #10720, eff 11-22-14; ss by #12671, eff
11-7-18
PART Ph 802 DEFINITIONS
Ph 802.01 Definitions. Except where the context makes another
meaning manifest, the following definitions shall apply:
(a) “Registered pharmacy technician” means a
person who is registered with the board, employed by a pharmacy, and who can assist in performing, under the
supervision of a licensed pharmacist, manipulative, nondiscretionary functions
associated with the practice of pharmacy and other such duties, subject to such
restrictions as the board has specified; and
(b)
“Certified pharmacy technician” means a pharmacy technician who has
become and who maintains national certification by taking and passing an exam
recognized by the board for the purpose of certifying technicians and who has
been certified by the board.
Source. #7535, eff 7-25-01, EXPIRED: 7-25-09
New. #10720, eff 11-22-14; ss by #12671, eff 11-17-18
PART Ph 803 REQUIREMENTS FOR REGISTERED PHARMACY
TECHNICIANS
Ph 803.01 Registered Pharmacy Technician
Qualifications.
(a)
An applicant for a registered pharmacy technician shall:
(1) Be at least 16 years of age;
(2) Have a high
school or equivalent diploma, or be working to achieve a high school or
equivalent diploma;
(3) Not have been convicted of a drug or
pharmacy-related felony or misdemeanor or admitted to sufficient facts to
warrant such a finding; and
(4) Register with
the board within 15 days of start date of employment as a pharmacy technician,
and post such registration in the pharmacy within 30 days.
(b)
No person shall perform
the functions or duties of a pharmacy technician unless such person is
registered by the board.
Source. #7535, eff 7-25-01; amd by #8572, eff
2-23-06; paras (a) & (b) EXPIRED: 7-25-09; paras. (c) and (d) EXPIRED:
2-23-14
New. #10720, eff 11-22-14; ss by #12671, eff 11-17-18
(formerly Ph 807.02)
Ph 803.02 Application Procedures for Registered
Pharmacy Technicians.
(a) Registered pharmacy technician applicants shall complete and submit an “Initial
Application for Pharmacy Technician Registration” form (PT-1), or electronic
equivalent, for registration to the board that contains the following:
(1) Legal name, residence address, mailing
address, home or cell phone number, personal e-mail address, and social
security number of the applicant;
(2) Date and place of birth and gender of the
applicant;
(3) Name of current employer and the mailing
address, phone number, and e-mail address of employment site;
(4) Name of supervisor and pharmacy phone number;
(5) An indication as to whether or not the
applicant has been convicted of a drug or pharmacy-related felony or
misdemeanor or admitted to sufficient facts to warrant such a finding, and if
yes, an explanation, an explanation of the circumstances surrounding such a
finding or conviction;
(6) An indication as to whether the applicant has
ever voluntarily surrendered for disciplinary reasons a license, registration,
or certification to practice as a pharmacy technician in any jurisdiction and,
if so, an explanation of such surrender;
(7) An indication as to whether the applicant has
any felony convictions and, if so, an explanation of such convictions; and
(8) Applicant's signature and date.
(b)
The prescribed fee shall be $100, and shall be submitted with the
completed application form.
(c)
The “Initial Application
for Pharmacy Technician Registration” form PT-1 for registration of pharmacy
technicians in New Hampshire may be obtained from and shall be filed at the office of the board, identified in Ph
103.03.
Source. #12671, eff 11-17-18
PART Ph 804 REGISTERED PHARMACY TECHNICIAN RENEWALS
Ph 804.01 Renewal Requirements for Registered
Pharmacy Technicians.
(a)
All pharmacy technician
registrations shall expire biennially on March 31.
(b)
Applications for the renewal of a registration for a pharmacy technician
may be obtained from, and shall be filed at the office of the board, identified
in Ph 103.03.
(c) A pharmacy technician applying for renewal
shall do so online at https://nhlicenses.nh.gov/eGov/Login.aspx by providing the following information:
(1) Legal name, residence address, mailing
address, personal e-mail address, and a mobile or home telephone number;
(2) License number and work email address of the
pharmacist-in-charge;
(3) Name and phone number of current employer and
address of employment site;
(4) Record of convictions of violations of
federal, state or local drug or pharmacy related laws or regulations; and
(5) Applicant’s signature and date.
(d) The
application and the prescribed fee of $100 shall be filed with the board no
later than March 15.
Source. #7535, eff 7-25-01, EXPIRED: 7-25-09
New.
#10720, eff 11-22-14; ss by #12671, eff 11-17-18 (formerly Ph 806.01)
PART Ph 805 ONGOING REQUIREMENTS FOR REGISTERED PHARMACY
TECHNICIANS
Ph 805.01 Change in Registration Information for
Registered Pharmacy Technicians.
(a)
The person to whom a pharmacy technician registration has been issued
shall, within 15 days of a change of address or location of employment, notify
the board of such changes.
(b)
The notice shall contain:
(1) Legal name of registrant;
(2) Address, phone number, and personal email
address of the registrant, including old and new, if applicable;
(3) Registrant’s registration number;
(4) Name of the pharmacy where employed including
former and current, if applicable; and
(6) All new violations of law, convictions,
fines, disciplines or any registration, certification, or license revocations
for violation of pharmacy-related drug laws or regulations in this or any other
state.
(c)
Failure to comply with Ph 805.01 shall constitute misconduct under RSA
318.
Source. #7535, eff 7-25-01, EXPIRED: 7-25-09
New. #10720, eff 11-22-14; ss by #12671, eff 11-17-18
Ph 805.02 Penalty. Any registered pharmacy technician who
alters, forges, or intentionally falsifies, or causes to be altered, forged or
falsified, any information, documents, or records required to be kept or
submitted by this rule shall be subject to disciplinary action under RSA
318:29, II.
Source. #12671, eff 11-17-18 (formerly Ph 806.05)
PART Ph 806 REVOCATION, DENIAL, AND REINSTATEMENT OF
REGISTERED PHARMACY TECHNICIANS
Ph 806.01 Effect of Revocation and Denial for
Registered Pharmacy Technicians.
(a) The board shall refuse to issue a
registration or, after notice and hearing, shall revoke a registration whenever the board
finds by the preponderance of the evidence any of the following:
(1) That the applicant, or registrant, has
violated any of the provisions of RSA 318, RSA 318-B, or the board’s
administrative rules;
(2) That the applicant has been convicted of a
felony or a misdemeanor resulting from a violation of any federal, state, or
local drug or pharmacy-related law, rule or regulation;
(3) That the applicant has attempted to obtain a
pharmacy technician registration by fraudulent means;
(4) That the applicant is unable to engage in the
performance of pharmacy technician functions with reasonable skill and safety
by reason of illness, inebriation, misuse of drugs, narcotics, alcohol,
chemicals or any other substance, or as a result of any mental or physical
condition;
(5) That another state has suspended, revoked, or
placed on probation the applicant’s license, permit, or registration to
practice as a pharmacy technician;
(6) That the applicant refused to appear before
the board after having been ordered to do so in writing; or
(7) That the applicant made any fraudulent or
untrue statement to the board.
(b)
The pharmacist on duty shall notify the board, in writing, within one
calendar day after becoming aware that a pharmacy technician has adulterated, abused, stolen or diverted
drugs.
(c)
The board shall reinstate
a revoked technician’s previous permit after review, provided that the reason
for revocation no longer exists or it is determined that there is no longer a
threat to public safety.
Source. #7535, eff 7-25-01, EXPIRED: 7-25-09
New. #10720, eff 11-22-14; ss by #12671, eff 11-17-18
Ph 806.02 Reinstatement of a Registered Pharmacy
Technician. Registered pharmacy
technicians who either voluntarily or accidentally allow their registration to
lapse as of March 31 of the renewal year shall complete the following
procedures to reinstate their registration:
(a) Complete a reinstatement
application found on the board’s website at https://www.oplc.nh.gov/pharmacy/documents/technician-reinstatement.pdf (revised April
2018);
(b)
Submit the completed application and the prescribed fee to the board’s
office;
(c)
Submit any required documentation, as indicated on the form; and
(d)
Submit a signed and dated statement as to why the applicant did not
renew his or her pharmacy technician registration prior to expiration and
whether or not the applicant has practiced as a pharmacy technician since his
or her registration has lapsed.
Source. #7535, eff 7-25-01, EXPIRED: 7-25-09
New. #10720, eff 11-22-14; ss by #12671, eff 11-17-18
PART Ph 807 REGISTERED PHARMACY TECHNICIANS – STANDARDS
OF PRACTICE
Ph 807.01 Determination of a Registered Pharmacy
Technician’s Duties.
(a)
A pharmacy technician shall only perform such tasks and duties which are
prescribed by the permit holder or pharmacist-in-charge based upon the needs of
the pharmacy.
(b) A pharmacy technician’s duties may
be further limited by the pharmacist on duty or the supervising pharmacist.
(c)
Any training given under the direction of a pharmacist shall be
documented by the pharmacist-in-charge and be retrievable upon inspection.
Source. #7535, eff 7-25-01; amd by #8572, eff 2-23-06;
para (d) EXPIRED: 7-25-09; paras. (a)-(c) and (e) EXPIRED: 2-23-14
New. #10720, eff 11-22-14; ss by #12671, eff
11-7-18
Ph 807.02 Registered Pharmacy Technician Duties. A registered pharmacy technician’s duties,
upon showing the requisite skill and receiving the appropriate training, shall
be:
(a)
Non-discretionary functions within the pharmacy concerning cashier,
stocking, delivery, and other non-clinical functions necessary for pharmacy
operation under the supervision of a licensed pharmacist or certified pharmacy
technician;
(b) Performing the data entry of a
prescription or medication order into the computer;
(c) The counting, weighing,
measuring, pouring, and reconstitution of non-parenteral prescription
medication or stock legend drugs and controlled substances;
(d) Performing stocking or
replenishment of automated dispensing machine, other automated dispensing
equipment, or other stock
locations. Products shall be verified by
a pharmacist or certified pharmacy technician.
Bar-coding, radio frequency identification, or another form of electronic
verification shall be used at the time of stocking or replenishment, or a
licensed health professional shall check the medication before administration;
and
(e) If in training to
become a certified technician, the duties of a certified pharmacy technician
under the direct supervision of a pharmacist or certified pharmacy technician.
Source. #10720, eff 11-22-14; ss by #12671, eff 11-17-18;
ss by #12951, eff 12-21-19; ss by #13385, eff 5-26-22
PART Ph 808 REQUIREMENTS FOR CERTIFIED PHARMACY
TECHNICIANS
Ph 808.01 Certified Pharmacy Technician
Qualifications.
(a)
An applicant for a certified pharmacy technician shall:
(1) Be at least 18 years of age;
(2) Have a high school or equivalent diploma;
(3) Obtain and maintain national certification from a nationally
recognized certifying organization, such as the Pharmacy Technician
Certification Board (PTCB) or the National Healthcare Association (NHA);
(4) Not have been convicted of a drug or
pharmacy-related felony or misdemeanor or admitted to sufficient facts to
warrant such a finding; and
(5) Seek certification from the board within 15
days of the start date of employment as a certified pharmacy technician, and
post such certification in the pharmacy within 30 days.
(b) A certified pharmacy
technician with duties involving sterile and non-sterile compounding, shall
complete an American Society of
Hospital Pharmacies (ASHP), PTCB, or other nationally recognized training
program before participating in those duties.
(c) Pharmacy technician
applicants with previous out of state experience shall meet the requirements
set by the board in this section before obtaining certification status.
(d) No person shall perform the functions or duties
of a certified pharmacy technician unless such person is certified by the
board.
Source. #12671, eff 11-17-18; ss by #13385, eff
5-26-22
Ph 808.02 Application Procedures
for Certified Pharmacy Technicians.
(a) Pharmacy technician applicants shall complete
and submit an application form “Initial Application for Pharmacy Technician
Registration” form PT-1, or electronic equivalent, for certification by the
board that contains the following:
(1) Legal name, residence address, mailing
address, home telephone number, personal e-mail address, and social security
number of the applicant;
(2) Date and place of birth, and gender of the
applicant;
(3) Name of current employer and the mailing
address, and phone number of employment site;
(4) Name of supervisor and pharmacy phone number;
(5) An indication as to whether or not the
applicant has been convicted of a drug or pharmacy-related felony or admitted
to sufficient facts to warrant such a finding, and if yes, an explanation of
the circumstances surrounding such a finding or conviction;
(6) An indication as to whether the application
has any other felony convictions and, if so, an explanation of such
convictions; and
(7) Applicant's signature and date.
(b)
The prescribed fee shall be $100, and shall be submitted with the
completed application form.
(c)
“The Initial Application for Pharmacy Technician Registration” form for
pharmacy technicians in New Hampshire may be obtained from and shall be filed at the office of the
board, identified in Ph 103.03.
Source. #12671, eff 11-17-18
PART Ph 809 CERTIFIED PHARMACY TECHNICIAN RENEWALS
Ph 809.01 Renewal Requirements for Certified
Pharmacy Technicians.
(a)
All certified pharmacy technician certifications shall expire biennially
on March 31.
(b)
Applications for the renewal of a certification for a pharmacy
technician may be obtained from, and shall be filed at the office of the board,
identified in Ph 103.03.
(c) A pharmacy technician
applying for renewal shall do so online at https://nhlicenses.nh.gov/eGov/Login.aspx by providing the following information about him or herself:
(1) Legal name, residence address, mailing
address, personal e-mail address, and a mobile or home telephone number;
(2) License number and work email address of the
pharmacist-in-charge;
(3) Name and phone number of current employer and
address of employment site;
(4) Record of convictions of violations of
federal, state or local drug or pharmacy related laws or regulations;
(5) Report or copies
of continuing education;
(6) Certification
status; and
(7) Applicant’s
signature and date.
(d) The application and the prescribed fee of
$100 shall be filed with the board no later than March 15.
Source. #12671, eff 11-17-18
PART Ph 810 ONGOING REQUIREMENTS FOR CERTIFIED PHARMACY
TECHNICIANS
Ph 810.01 Changes in
Certification Information for Certified Pharmacy Technicians.
(a)
The person to whom a pharmacy technician certification has been issued
shall, within 15 days of a change of address
or location of employment, notify the board of such changes.
(b)
The notice shall contain:
(1) Legal name of certified pharmacy technician;
(2) Address, phone
number, and personal email address of the certified pharmacy technician,
including old and new, if applicable;
(3) Certified pharmacy technician’s New Hampshire
permit number;
(4) Name of the pharmacy where employed including
former and current, if applicable;
(5) Certification status; and
(6) All new violations of law,
convictions, fines, disciplines or any registration, certification, or license
revocations for violation of pharmacy-related drug laws or regulations in this
or any other state.
(c)
Failure to comply with Ph 810.01 shall constitute misconduct under RSA
318.
Source. #12671, eff 11-17-18
Ph 810.02 Continuing Education Requirements for
Certified Pharmacy Technicians.
(a)
Certified pharmacy technicians shall maintain their nationally certified
status and stay up to date with all continuing education requirements such
certification demands.
(b)
A certified pharmacy technician shall retain all certificates and/or
other documented evidence of participation in an approved/accredited continuing
education program/course for a period of 3 years. Such documentation shall be made available to
the board for random audit or verification.
(c)
Certified pharmacy technicians with duties involving sterile and
non-sterile compounding shall complete a minimum of 0.4 CEU’s in the area of
compounding.
(d)
Not less than 10% of certified pharmacy technicians shall be randomly
selected each year by the board for determinations of compliance.
Source. #12671, eff 11-17-18 (formerly Ph 806.04)
Ph 810.03 Excess Continuing Education Requirements
for Certified Pharmacy Technicians.
Excess continuing education units earned in one licensure period shall
not be carried forward into the new licensure period for the purpose of
fulfilling that year’s continuing education prerequisite for licensure renewal.
Source. #12671, eff 11-17-18
Ph 810.04 Penalty. Any certified pharmacy technician who alters,
forges, or intentionally falsifies, or causes to be altered, forged or
falsified, any information, documents, or records required to be kept or
submitted by this rule shall be subject to disciplinary action under RSA
318:29, II.
Source. #12671, eff 11-17-18 (formerly Ph 806.05)
PART Ph 811 REVOCATION, DENIAL, AND REINSTATEMENT OF
CERTIFIED PHARMACY TECHNICIANS
Ph 811.01 Effect of Revocation and Denial for a
Certified Pharmacy Technician.
(a)
The board shall refuse to issue a certification or, after notice and
hearing, shall revoke a certification whenever the board finds, by the
preponderance of the evidence, any of the following:
(1) That the applicant, or certified pharmacy
technician, has violated any of the provisions of RSA 318, RSA 318-B, or the
board’s administrative rules;
(2) That the applicant has been convicted of a
felony or a misdemeanor resulting from a violation of any federal, state, or
local drug or pharmacy-related law, rule or regulation;
(3) That the applicant has attempted to obtain
certified pharmacy technician status by fraudulent means;
(4) That the applicant is unable to engage in the
performance of certified pharmacy technician functions with reasonable skill
and safety by reason of illness, inebriation, misuse of drugs, narcotics,
alcohol, chemicals or any other substance, or as a result of any mental or
physical condition;
(5) That another state has suspended, revoked, or
placed on probation the applicant’s license, permit, certification, or
registration to practice as a pharmacy technician;
(6) That the applicant refused to appear before
the board after having been ordered to do so in writing; or
(7) That the applicant made any fraudulent or
untrue statement to the board.
(b)
The pharmacist-in-charge shall notify the board, in writing, within one
calendar day after becoming aware that a pharmacy technician has adulterated, abused, stolen or diverted
drugs.
(c)
The board shall issue a new certification after review, provided that
the reason for revocation no longer exists or it is determined that there is no
longer a threat to public safety.
Source. #12671, eff 11-17-18
Ph 811.02 Reinstatement of a Pharmacy Technician
Certification. Certified pharmacy
technicians who either voluntarily or accidentally allow their certification to
lapse as of March 31 of the renewal year shall complete the following
procedures to reinstate their certification:
(a) Complete a
reinstatement application found on the board’s website at https://www.oplc.nh.gov/pharmacy/documents/technician-reinstatement.pdf (revised April 2018);
(b)
Submit the completed application and the prescribed fee to the board’s
office;
(c)
Submit any required documentation as outlined on the form;
(d)
Submit a signed and dated statement as to why the applicant did not
renew his or her pharmacy technician certification prior to expiration and
whether or not the applicant has practiced as a pharmacy technician since his
or her certification has lapsed.
(e)
Submit a current national certification certificate; and
(f)
Submit proof of continuing education as defined in Ph 805.02 completed
within the immediately preceding 24 months.
Source. #12671, eff 11-17-18
PART Ph 812 CERTIFIED PHARMACY TECHNICIANS – STANDARDS OF
PRACTICE
Ph 812.01 Determination of a Certified Pharmacy
Technician’s Duties.
(a)
Any certified pharmacy technician who does not maintain national
certification shall notify the board and the pharmacist–in-charge immediately
of the lapse of certification. Those
whose certification has lapsed shall be permitted to perform the duties of a
registered pharmacy technician, but shall no longer perform the additional
duties of a certified pharmacy technician.
(b)
A certified pharmacy technician shall only perform such tasks and duties
which are prescribed by the permit holder or pharmacist-in-charge based upon
the needs of the pharmacy.
(c)
A certified pharmacy technician’s duties may be further limited by the
pharmacist on duty or the supervising pharmacist.
(d)
Any training given under the direction of a pharmacist shall be
documented by the pharmacist-in-charge and be retrievable upon inspection.
Source. #12671, eff 11-17-18
Ph 812.02 Certified Pharmacy Technicians Duties.
(a)
A certified pharmacy technician’s duties shall include:
(1) Any duties performed by registered pharmacy
technicians under Ph 807.02;
(2) Accepting a new oral telephone order;
(3) Accepting an oral refill authorization;
(4) Communicating a prescription transfer for a
non-control medication to or from another pharmacy that does not maintain a
common database;
(5) Communicating
orally or in writing, any medical, therapeutic, clinical, or drug information,
or any information recorded on a patient profile that does not require
professional judgment;
(6) Performing the data entry
of a prescription or medication order into the computer;
(7) The task of reducing to
writing a prescription left on a recording or message line;
(8) Preparing or compounding
sterile and non-sterile compounds;
(9) Verifying stock replenishment
medications against the stocking/replenishment system, report or label prior to
the stocking/replenishment of the automated dispensing machine, other automated
dispensing equipment, or other stock location provided that bar-coding, radio
frequency identification or another form of electronic verification is used at
the time of stocking/replenishment, or a licensed health professional checks
the medication before administration to the patient;
(10) Clarification of an original
prescription or drug order with a practitioner or authorized agent of the
practitioner; and
(11) Preparation, verification,
and sealing of an emergency kit.
Source. #12671, eff 11-17-18 (formerly Ph 807.03); ss
by #12951, eff 12-21-19
CHAPTER Ph 900 MAIL-ORDER/NON-RESIDENT PHARMACY
Statutory
Authority: RSA 318:37, II
PART Ph 901 PURPOSE AND SCOPE
Ph 901.01 Scope.
The provisions of this chapter shall apply to, and impose duties upon,
all mail-order pharmacies holding registrations issued by the board.
Source. #7474, eff 4-5-01; ss by #9341, eff 12-4-08;
ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
PART Ph 902 DEFINITIONS
Ph 902.01 “Telepharmacy services” refers to the
practice of pharmacy using telecommunications technology to oversee pharmacy
operations and patient care.
Source. #7474, eff 4-5-01; ss by #9341, eff 12-4-08;
ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
Ph 902.02 “Mail-order pharmacy” means “mail-order pharmacy” as defined in RSA
318:1, VII-b, namely, “a pharmacy that is located in a state of the United
States, other than this state, whose primary business is to dispense a
prescription drug or device under a prescription drug order and to deliver the
drug or device to a patient, including a patient in this state, by the United
States mail, a common carrier, or a delivery service. Mail-order pharmacies include, but are not
limited to, pharmacies that do business via the Internet or other electronic
media.”
Source.
#13244, eff 7-30-21 (formerly Ph 902.01)
PART Ph 903 REGISTRATION
Ph 903.01 Application.
(a)
No person shall conduct or operate a mail-order pharmacy located outside
of this state by delivering in any manner prescription drugs or prescription
devices into this state unless such pharmacy is registered in New Hampshire and
a permit has been issued by the board.
(b) Application form MO-1, “Non-Resident/Mail-Order
Pharmacy Application for Permit” revised 3/2022 may be obtained from and
shall be filed at the office of the board, identified in Ph 103.03.
(c) Applicants for
registration as a mail-order pharmacy shall complete and submit form MO-1 or
its electronic equivalent that contains the following information:
(1) Name, address, telephone number, email
address, and internet address, if applicable, of the pharmacy;
(2) The names, addresses and titles of all
principal corporate officers, if incorporated and if unincorporated, partners
or owners of the pharmacy;
(3) If a corporation, a certificate of
incorporation from the state in which incorporated;
(4) If a limited liability company, partnership,
or sole proprietorship, a tax ID number or FEIN number;
(5) The name, phone number, email address, and
home-state pharmacist license number of the pharmacist-in-charge of the
location listed in (1) above;
(6) A copy of the pharmacy’s home state permit;
(7) A copy of the most recent inspection report
conducted by the state in which the pharmacy is located within the past 18
months;
(8) An un-redacted copy of the most recent United
States Food and Drug Administration inspection and 483 observation(s) and board
approved inspections as defined in Ph 906.03(c) and (d)(1) from the applicant’s
home state;
(9) A copy of the un-redacted inspection and
observation response, if applicable;
(10) If the pharmacy is exempt from registering
with the PDMP, complete the following attestation:
“I attest, that
the above-named pharmacy, for which I am the Pharmacist In Charge, is exempt
from registering and reporting to the New Hampshire Prescription Drug
Monitoring Program per NH RSA 318-B:33:
□ The Pharmacy does not have a Drug Enforcement
Administration (DEA) Registration at all and does not do any business
(dispensing, distributing, and/or shipping related to any Federally Scheduled
Controlled Substances in either the pharmacy’s home-state or any other U.S.
State; or
□ The pharmacy only has a Drug Enforcement
Administration (DEA) registration for schedule V Controlled Substances and does
not do any business with Schedule II-IV Controlled Substances (dispensing,
distributing, and/or shipping) in either the pharmacy’s home-state or any other
U.S. state – if selecting this box, you Must attach a copy of the pharmacy’s
current DEA registration.
By signing below I
understand and affirm, that should the above-named pharmacy obtain a DEA
registration for schedule II-IV and/or aspire to begin distributing/dispensing
controlled substances in these schedules (either in its home-state or any other
state), that I, and this pharmacy, will immediately notify the New Hampshire
Board of Pharmacy and properly submit the required application as defined in Ph
904, and register with the NH Prescription Drug Monitoring Program as required
by NH RSA 318-B:33”; and
(11) The signature of the pharmacist-in-charge and
date below the following attestation:
“I attest that I
have read the NH Laws; RSA 318 and RSA 318-B and Administrative Rules for the
profession that I have applied for on this renewal. I attest to reading Ph 904.01; which states
in part, 'the Board must be notified within 30 days of any changes to any
information from the original application'.
I attest that I have answered all questions truthfully, accurately and I
hereby attest that if any information on this application was submitted falsely
or is misleading or a misrepresentation of the facts, I understand that such an
act shall constitute cause for potential denial, revocation, or disciplinary
actions of the registration that I am applying for. I understand that the
pharmacy permit is issued in the name of the corporation or owner of the
pharmacy and that a duly designated pharmacist in charge, as designated on this
application, has accepted responsibility for the safe, effective operation of
the pharmacy. My signature; ink or
electronic; constitutes my acknowledgement of the responsibilities of both the
pharmacist in charge and the corporation/owner/permit holder regarding the safe
operation of the pharmacy.”
(d)
Documents required for an initial application shall include:
(1) A copy of the home state permit;
(2) A copy of a prescription label, containing
the name, address, and phone number of the pharmacy, that would be used on
finished prescription products mailed to NH residents;
(3) A copy of the inspection report of the
facility, created in the last 18 months, from one of the entities listed in Ph
906.03(d)(1);
(4) A list of all the corporate officers, owners,
title, and organization chart;
(5) A sample copy of a printed patient medication
profile that shall include the following information:
a. Name and address of the patient;
b. Name, address and DEA registration number of
the prescriber;
c. Name, strength, and quantity of drug
dispensed;
d. Assigned prescription number;
e. Date of original filling; and
f. Date of refill(s);
(6) Pictures of the following locations at the
facility:
a. At least
2 different photographs of the actual
existing exterior, including the pharmacy signage,
of the building in which the
pharmacy will be or is currently located;
b. At least 2
different photographs of the prescription department as viewed by an
approaching patron;
c. At least 4 different photographs of the prescription department as viewed from the interior,
showing the prescription compounding area,
refrigerator, water facilities, and pharmaceutical inventory storage area;
(7) A copy of the certificate of the alarm system
is in place, or other proof the facility is alarmed;
(8) Scaled drawing of the facility and drug
storage area;
(9) Copies of the following documents:
a. A copy of an inspection report, created
within the last 18 months, which documents compliance with the board rules
regarding sterile and non-sterile compounding in compliance with the United
States Pharmacopeia Chapter 797 and Chapter 795 pursuant to RSA 318:14-a
performed by:
1. Your home state’s board of pharmacy;
2. The National Association of Boards of
Pharmacy (NABP); or
3. New Hampshire board of pharmacy approved
third party entity;
b. The below attestation, signed by the
pharmacist-in-charge:
“ Sterile
Compounded Drugs (Patient-Specific Only) * If shipping Sterile Compounded
Products to NH Residents, you must attach items 1-5; additionally, by signing
this application you acknowledge that the pharmacy has item #6 on hand and
available upon request:
1. Any and all GAP analysis reports related to
the pharmacy done within the last 12 months;
2. Any and all certification documents on
compounding equipment done within the last 6 months;
3. An inventory listing of any and all products
shipped into the State of New Hampshire within the last 6 months, including
product, quantity, location of shipment, and date of shipment;
4. Any Department of Health and Human Services,
Food and Drug Administration Inspection Reports (Form FDA 483) issued within
the last 12 months and any responses submitted to these agencies by the
pharmacy;
5. Any state inspection reports issued within the
last 18 months and any responses submitted to these agencies regarding the
inspection reports by the pharmacy; and
6. The pharmacy’s policies and procedures on
sterile compounding. (Do not attach –
but must be available upon request);”
c. A hood certification inspection report
completed under dynamic conditions, not at rest, within the last 6 months;
d. A current environmental monitoring report,
dated within the last 6 months, which includes:
1. Viable air and surface sampling; and
2. HEPA filter performance testing;
e. If the facility does not have a clean report,
submit the following as well:
1. CAPA Report;
2. Identify the issue and explain in writing to
the board;
3. A detailed report of what the corrective
action plan is; and
4. A statement explaining if this is detailed in
the facility’s SOPs or P&P Manual; and
(10) The fee as specified in Plc 1000.
(e)
Failure to comply with any of the provisions of Ph 903 shall result in
denial of a permit.
(f) Initial applications shall remain open and active for 60
days upon receipt of a completed application.
An application is considered completed when all documentation required
by the rules, application, any other supporting documentation to show proof the
company is compliant with board rules, and the fee, are received by the
board. If the application and all
supporting documentation are not completed by the applicant within 60 days, the
application will turn to an inactive status and the applicant will have to
begin the process from the beginning.
(g)
Any person or pharmacy whose pharmacy business model fits the definition
of a mail-order pharmacy and delivers prescription
drugs or prescription devices to New Hampshire residents from more than one
out-of-state pharmacy shall register each such pharmacy separately.
(h) Pharmacists providing “telepharmacy services”
to New Hampshire residents shall be licensed with the board unless performing
these actions on behalf of a pharmacy licensed or otherwise registered by the
board.
Source. #7474, eff 4-5-01; amd by #9139-B, eff
4-25-08; ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14; ss by #13244, eff
7-30-21; ss by #13384, eff 5-26-22
PART Ph 904 REGISTRATIONS – CHANGES IN SUPPORTING DATA
Ph 904.01 Reporting Changes.
(a)
The mail-order pharmacy to which a registration has been issued shall
within 30-days of any change of information supplied in the original
application, notify the board.
(b)
The notice required pursuant to (a) above shall contain:
(1) Current New Hampshire registration number;
(2) Name of the pharmacy, old and new;
(3) Address of the pharmacy;
(4) Name of the pharmacist-in-charge;
(5) The effective date of the change; and
(6) The reason for
the change.
(c)
A new application shall be required for a change of ownership of an
established pharmacy to a successor business
entity which results in a change in the controlling interest in the pharmacy
and include:
(1) A change from the parent level down shall
require a new application to be submitted within 30 days after the effective
date of the change; and
(2) A change from the
grandparent level up submit a letter on company letterhead, dated and signed,
including the information as outlined in Ph 904.01 (b) above. The letter shall be submitted by attaching to
an email to pharmacy.licensing@oplc.nh.gov with the NH registration number in
the subject line.
(d)
If a new license is issued as a result of (c) above a new license number
shall be issued.
(e)
If a company is already established in New Hampshire as a permit holder
and would like to change its business practice model to include
dispensing/shipping controls into New Hampshire, the company shall submit the
following:
(1) Initial
application that notes your current NH license number, along with all
supporting documentation as required by Ph 903, excluding the fee; and
(2) This
application to add on the dispensing/shipping controls into New Hampshire,
shall be submitted 60 days prior to the anticipated beginning of
shipping/dispensing date.
(e) The pharmacy shall receive an
updated permit, from the board that shows they have been authorized by the
board, before beginning to dispense/ship into NH.
(f)
Any failure to notify the board of any of the changes listed in Ph 904
or the original application as submitted to the board shall result in the
commencement of disciplinary proceedings if there is evidence that the failure
to notify the board:
(1) Was knowingly or negligently made; and
(2) Is a violation of RSA 318:29, II, other
applicable laws, or rules adopted by the office of professional licensure and
certification, or the board.
Source. #7474, eff 4-5-01; ss by #9341, eff 12-4-08;
ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
PART Ph 905 REVOCATION AND DENIAL
Ph 905.01 Effect of Revocation
and Denial.
(a)
The board shall refuse to issue a registration or shall revoke a registration whenever the board
determines that a mail-order pharmacy, its pharmacist-in-charge, owner(s), or
corporate officer(s) has, after notice and opportunity for a hearing, except
pursuant to (c) below, committed misconduct such as but not limited to:
(1) Made a materially false representation or
withheld material information in connection with obtaining its registration;
(2) Been found guilty of any felony in connection
with the practice of pharmacy or distribution of drugs within the past 5 years;
(3) Made false representations in connection with
the practice of pharmacy that endanger or are likely to endanger the health or
safety of the public, or that defraud any person;
(4) Failed to comply with RSA 318:37, II, the
provisions of Ph 900, or both;
(5) Based on an investigation of a complaint
resulting from the dispensing of prescription drugs or prescription devices to
a resident of New Hampshire been found to be negligent:
a. By the board of pharmacy of the state in
which the pharmacy is located; or
b. By the board if the board of pharmacy of the
state where the pharmacy is located failed to initiate an investigation of such
complaint within 45-days after referral of the complaint from the board; or
(6) Been found guilty of any violation of
federal, state, or local drug law or have entered into any agreement to resolve
violations of such.
(b)
A mail-order pharmacy shall notify the board within 15 days of any
initial disciplinary action by a board of pharmacy, or any other state or
federal agency, imposing disciplinary action on the pharmacy.
(c) Notwithstanding the provisions of (a) above, if the license,
permit or registration in the state where the pharmacy is located, is suspended
or revoked, then the pharmacy’s registration in New Hampshire shall, after
notice and opportunity for hearing, be suspended or revoked for the same period
of time.
(d)
Notwithstanding the above, the board shall issue a registration or not
revoke if:
(1) No harm resulted from the actions of the
applicant or registrant;
(2) There was no intent to violate any provisions
of RSA 318;
(3) Corrective action has been taken by the
registrant;
(4) Remunerations have been made to the affected
party(s); and
(5) The board determines the action is unlikely
to occur again.
Source. #7474, eff 4-5-01; ss by #9341, eff 12-4-08;
ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
PART Ph 906 RENEWAL OF REGISTRATIONS
Ph 906.01 Renewal Registrations Required. All mail-order pharmacy registrations shall
expire on December 31 biennially in each odd-numbered
year for odd-numbered licenses or on December 31 of each even-numbered year for
even-numbered licenses.
Source. #7474, eff 4-5-01; ss by #9341, eff 12-4-08;
ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
Ph 906.02 Renewal Application
Where Obtained and Filed.
Applications for the renewal of a registration for a mail-order pharmacy
may be obtained from, and shall be filed at, the office of the board,
identified in Ph 103.03 or online.
Source. #7474, eff 4-5-01; ss by #9341, eff 12-4-08;
ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
Ph 906.03 Renewal Application Contents and When
Filed. Renewal applications shall be
filed with the board in accordance with the following:
(a) Applications for renewal of a registration
for a mail-order pharmacy shall be made by using the on-line form
“License/Permit/Registration Renewal”, revised edition 9/2014, located on the
office of professional licensure and certification web site, https://forms.nh.gov/license/Login.aspx;
(b)
Documents to be submitted for
renewal shall be received by the office no later than November 30th for the
anticipated expiration date of December 30th.
(c) An applicant who
does not practice sterile or non-sterile compounding shall submit the
following:
(1) A copy of the pharmacy’s home state permit;
(2) A copy of the pharmacy’s controlled
substances permit if issued by the pharmacy’s home state;
(3) A copy of the DEA certificate;
(4) A copy of the pharmacy’s full, un-redacted
inspection report created within the last 24 months, showing compliance with
board rules, or a certificate of accreditation;
(5) A copy of any responses to
any violations or discipline and your company’s plan of action to bring your
facility into compliance. Such responses
shall be signed and dated by the person that is responsible for the actions of
the permit or pharmacist in charge; and
(6) The application and the fee as specified in
Plc 1000;
(d) An applicant who practices sterile and non-sterile compounding shall submit the
following to renew the pharmacy permit biennially:
(1) A copy of an inspection report, created
within the last 18 months, which documents compliance with the board rules regarding sterile
and non-sterile compounding in compliance with the United States Pharmacopoeia
Chapter 797 and Chapter 795 pursuant to RSA 318:14-a, I performed by:
a. The pharmacy’s home state’s board of
pharmacy;
b. The NABP; or
c. Board approved third party entity;
(2) A copy of the home state board of pharmacy
permit;
(3) The below attestation, signed and dated by
the pharmacist in charge:
“ Sterile
Compounded Drugs (Patient-Specific Only) * If shipping Sterile Compounded
Products to NH Residents, you must attach items 1-5; additionally, by signing
this application you acknowledge that the pharmacy has item #6 on hand and
available upon request:
1. Any and all GAP analysis reports related to
the pharmacy done within the last twelve (12) months;
2. Any and all certification documents on
compounding equipment done within the last six (6) months;
3. An inventory listing of any / all products
shipped into the State of New Hampshire within the last six (6) months,
including product, quantity, location of shipment, and date of shipment;
4. Any Department of Health and Human Services,
Food and Drug Administration Inspection Reports (Form FDA 483) issued within
the last twelve (12) months and any responses submitted to these agencies by
the pharmacy;
5. Any state inspection reports issued within
the last eighteen (18) months and any responses submitted to these agencies
regarding the inspection reports by the pharmacy; and
6. The pharmacy’s policies and procedures on
sterile compounding. (Do not attach – but must be available upon request);”
(4) A hood certification inspection report
completed under dynamic conditions, not at rest, within the last 6 months;
(5) A Copy of the DEA permit;
(6) An environmental monitoring report, dated
within the last 6 months, that includes:
a. Viable air and surface sampling; and
b. HEPA filter performance testing;
(7) If the facility does not have a clean report,
the applicant shall submit the following as well:
a. CAPA report;
b. Identify the issue and explain in writing to
the board;
c. Explain what the corrective action plan is;
and
d. An indication whether this is in the SOP’s
and P & P Manual; and
(8)
Inventory list of last 6 months of sterile compounded products shipped into NH
including:
a. Product name;
b. Quantity;
c. Location of shipment; and
d. Date of shipment.
Source. #7474, eff 4-5-01; amd by 9139-B, eff 4-25-08;
ss by #9341, eff 12-4-08; ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
Ph 906.04 Failure to Comply. Failure to comply with any of the provisions
of Ph 906 shall result in non-renewal of the pharmacy permit.
Source. #10663, eff 9-3-14; ss by #13244, eff 7-30-21
PART Ph 907 CONDITIONS OF REGISTRATION
Ph 907.01 Compliance. As conditions of registration, the mail-order
pharmacy shall:
(a)
Maintain at all times a valid unexpired permit, license, or registration
to conduct the pharmacy in compliance with the laws of the state in which it is
a resident;
(b)
Maintain in readily retrievable form, records of legend drugs, devices,
or both dispensed to New Hampshire patients;
(c)
Supply upon request, all information needed by the board to carry out
its responsibilities under the statutes
and rules pertaining to mail-order pharmacies;
(d)
Provide for a toll-free telephone or other virtual means of
communication for consultation between New Hampshire patients and a pharmacist at the mail-order pharmacy
who has access to the patient’s records, and ensure that such toll-free
telephone number(s) shall be placed upon the label affixed to each prescription
container;
(e)
Provide to the board,
upon request, a copy of the policies and procedures governing:
(1) Normal delivery protocols and times;
(2) Any special packaging or procedures used in
delivering temperature-sensitive drug products;
(3) The procedure to be followed if the patient’s
medication is not available at the mail-order pharmacy, or if delivery will be
delayed beyond the normal delivery time;
(4) The procedure to be followed upon receipt of
a prescription for an acute illness, which shall include a procedure for
delivery of the medication to the patient from the mail-order pharmacy at the
earliest possible time, such as courier delivery, or an alternative that
assures the patient the opportunity to obtain the medication at the earliest
possible time; and
(5) The procedure to be followed when the
mail-order pharmacy is advised that the patient’s medication has not been
received within the normal delivery time and that the patient is out of
medication and requires interim dosage until mail prescription drugs become
available;
(f)
All finished prescription products shipped to New Hampshire residents
shall be shipped in tamper-evident envelopes
or boxes;
(g)
A mail-order pharmacy shall not dispense or sell to the public any drug
which is adulterated or misbranded;
(h)
A mail-order pharmacy shall supply, upon request from the board, a
statement of origin of any specific drug dispensed to a New Hampshire resident;
and
(i) Any mail-order pharmacy shipping finished
prescription products into the State of New Hampshire shall use the address,
but without the name of the pharmacy, on file with the New Hampshire board of
pharmacy as the return address
on the labels of any package shipped into the State of New Hampshire. The return address shall be placed on the
package in a clear and prominent manner.
Source. #7474, eff 4-5-01; ss by #9341, eff 12-4-08;
ss by #10663, eff 9-3-14; ss by #13244, eff 7-30-21
CHAPTER
Ph 1000 STANDARDS OF PRACTICE FOR
MANUFACTURERS, WHOLESALERS AND DISTRIBUTORS
PART Ph 1001
LICENSING
Ph
1001.01 License Required.
(a) No person shall manufacture or act as a
wholesale distributor of prescription drugs or prescription devices without
first obtaining a license to do so from the board pursuant to this chapter. No license shall be issued or renewed for a
manufacturer or wholesale drug distributor unless the same shall be operated in
a manner prescribed by law and according to the rules adopted by the board with respect thereto.
(b) Separate licenses shall be required for each
manufacturing and distribution site owned or operated by a manufacturer or
wholesale distributor. Provided however,
that an agent or employee of any licensed manufacturer or wholesale distributor
shall not be required to be licensed under this section and may lawfully
possess prescription drugs and devices if the agency or employee is acting in
the usual course of his or her business or employment.
(c) All licenses for manufacturers and wholesale
distributors of prescription drugs and medical devices containing a
prescription drug shall expire biennially on June 30th of every
even-numbered year. The renewal
application may be obtained from the board office. Alternatively, applicants may file the
renewal application online at https://nhlicenses.nh.gov/eGov/Login.aspx.
(d) The prescribed fee for original and biennial
renewal licenses for manufacturers and wholesale distributors of prescription
drugs and devices shall be $500.
(e) No in-state license shall be issued until
such time as the applicant has satisfactorily completed a site inspection
performed by the board confirming the facility:
(1) Is of
suitable size, construction, and location to allow proper storage, handling and
security of drugs;
(2) Is located
in a commercially zoned area;
(3) Has
adequate outside lighting to allow for proper security;
(4) Has
notified the local police department that legend drugs are being stored at the
facility; and
(5) Has a
functioning alarm system in place.
Source.
#8447, INTERIM, eff 10-14-05, EXPIRED: 4-12-06
New. #8708, eff 8-23-06, EXPIRED: 8-23-14
New. #12007, eff 10-22-16 (formerly Ph 309.01); ss
by #13117, eff 10-15-20
Ph
1001.02 Obtaining and Filing a
License Application. Applications for licensure of manufacturers,
wholesalers and distributors may be obtained from, and shall be filed at, the
board office, identified in Ph 1003.03.
Source.
#8447, INTERIM, eff 10-14-05, EXPIRED: 4-12-06
New. #8708, eff 8-23-06, EXPIRED: 8-23-14
New. #12007, eff 10-22-16 (formerly Ph 309.02)
Ph
1001.03 Application Contents.
(a) The applicant for licensure shall complete
and submit the board provided form Ph A-5, revised 09/16.
(b) Applicants shall also submit 2 photographs of
the existing exterior of the facility in which the applicant is located. These photographs shall include any outside
signage. Artist sketches or architect
plans or drawings shall not be acceptable.
(c) Applicants shall also submit at least 4
photographs of the interior of the facility showing legend drug storage areas,
refrigeration units and any specially constructed areas for storage of
controlled substances.
(d) In-state applicants shall also submit a
scaled floor plan of the proposed facility.
(e) Applicants shall supply a list of all states
where licensed and include license number.
Source.
#8447, INTERIM, eff 10-14-05, EXPIRED: 4-12-06
New. #8708, eff 8-23-06, EXPIRED: 8-23-14
New. #12007, eff 10-22-16 (formerly Ph 309.03)
PART Ph 1002
OPERATIONS
Ph
1002.01 Storage Conditions.
(a) All facilities at which prescription drugs
are repackaged, wholesaled, stored, held, sold, offered for sale, exposed for
sale, or kept for sale shall provide storage areas that have:
(1) Adequate
lighting;
(2) Adequate
ventilation;
(3) Proper
sanitation;
(4) All drugs
or chemicals shall be stored at appropriate temperatures and humidity per label
requirements;
(5)
Refrigerator temperatures are monitored on a daily basis; and
(6) Room
temperature is maintained and monitored on a daily basis.
(b) A separate storage section shall be provided
for prescription drugs that are deteriorated, outdated, misbranded, or
otherwise adulterated.
Source.
#12007, eff 10-22-16 (formerly Ph 309.04)
Ph
1002.02 Facilities.
(a) All buildings in which prescription drugs are
wholesaled, repackaged, stored, held, sold, offered for sale, exposed for sale,
or kept for sale shall be of suitable size, construction, and location to meet
the requirements set forth in this chapter.
(b) Buildings shall meet all applicable federal,
state, and local standards. A facility
shall not be located in a residence. All
facilities shall be located in an area that is commercially zoned.
(c) A wholesale drug distribution facility shall
notify the local police department or other appropriate law enforcement agency
that it is a distributor of prescription drug products and controlled
substances.
Source.
#12007, eff 10-22-16 (formerly Ph 309.05)
Ph
1002.03 Security.
(a) Each wholesale drug distribution center shall
be equipped with an internal alarm system to detect entry after hours. The alarm system shall be of the type that
transmits a signal directly to a central station protection company, to a local
or state police agency that has a legal duty to respond, or a 24 hour control
station operated by the wholesale drug distributor.
(b) Manufacturers and wholesale drug distributors
shall ensure that all access from outside their premises is secure. This shall include, but not be limited to,
the installation of adequate lighting at the outside perimeter of the premises.
(c) Internal security policies shall be developed
to provide protection against theft by personnel.
Source.
#12007, eff 10-22-16 (formerly Ph 309.06)
Ph
1002.04 Recordkeeping.
(a) Inventories and other records of transactions
regarding the receipt and disposition of prescription drugs shall be maintained
and made available for inspection by the board's inspectors for a period of 2
years.
(b) Records may be kept at a central location
rather than at each distribution center, but records shall be made available
for inspection within 72 hours of request by the board's inspectors.
Source.
#12007, eff 10-22-16 (formerly Ph 309.07)
Ph
1002.05 Inspections.
(a) Inspections shall be performed by the board's
inspectors and be conducted at the request of the board.
(b) Inspections shall be conducted during normal
business hours.
(c) Information that is considered to contain
trade secrets or which might be proprietary in nature shall be protected from
public disclosure.
Source.
#12007, eff 10-22-16 (formerly Ph 309.08)
Ph
1002.06 Written Policies and
Procedures.
(a) Written policies and procedures shall be
developed by management personnel to assure that the manufacturer and wholesale
drug distributor prepares for, protects against, and handles crisis situations
that affect the security or operation of the facility. Such crises shall include fires, floods, or
other natural disasters, and situations of local, state or national emergency.
(b) Written policies and procedures described in
(a) above shall also provide for:
(1) The
management and correction of all errors or inaccuracies in inventories;
(2) The
assurance that any outdated stock, or any stock with an expiration date that,
in the wholesale drug distributor's view, does not allow sufficient time for
repacking or resale, shall be prepared for return to the manufacturer or
otherwise destroyed;
(3) The control
over the shipping and receiving of all stock within the operation; and
(4) A process
for storage and disposal of hazardous drugs.
(c) Policies and procedures will be reviewed on a
regular basis.
(d) A copy of the policies and procedures, or
sections thereof, shall be made available to the board upon request.
(e) All manufacturers, wholesalers and
distributors shall notify the board when it initiates a class I recall based on
an FDA inspection.
Source.
#12007, eff 10-22-16 (formerly Ph 309.09)
Ph
1002.07 Returned Goods. A wholesale operation shall maintain a
procedure for the proper handling and disposal of returned goods.
Source.
#12007, eff 10-22-16 (formerly Ph 309.10)
Ph
1002.08 Handling Recalls.
(a) A wholesale operation shall maintain a
written policy for handling recalls and withdrawals for products.
(b) Policies required by (a) above shall cover
all recalls and withdrawals of prescription drug products due to:
(1) Any
voluntary action on the part of the manufacturer;
(2) The
direction of the Food and Drug Administration, or any other federal, state or
local governmental agency; and
(3) Replacement
of existing merchandise with an improved product or new package design.
Source.
#12007, eff 10-22-16 (formerly Ph 309.11)
Ph
1002.09 Responsibility for Operation. A wholesale drug distribution operation shall
maintain a list of principals and persons in charge including officers,
directors, or primary stockholders and their qualifications.
Source.
#12007, eff 10-22-16 (formerly Ph 309.12)
Ph
1002.10 Compliance with State and
Federal Law.
(a) All manufacturers, wholesalers and
distributors shall comply with all applicable state and federal laws,
regulations and rules.
(b) All manufacturers, wholesalers and
distributors, doing business in New Hampshire, shall, before shipping or
distributing any prescription drug, verify that the recipient is properly
licensed to receive and possess such drugs.
(c) All manufacturers, wholesalers and
distributors, licensed and doing business in the state of New Hampshire, shall
not provide unsolicited controlled drug samples to licensed practitioners.
(d) A manufacturer’s license shall allow for the
direct wholesaling or distribution of such drugs to other licensed or
authorized recipients.
(e) A duly authorized agent of a manufacturer,
wholesaler or distributor licensed in this state, may possess and distribute
potent or prescription drugs to individuals who may lawfully possess such drugs
as may be necessary to further the licensed activity of the manufacturer,
wholesaler or distributor.
Source.
#12007, eff 10-22-16 (formerly Ph 309.13)
Ph
1002.11 Violations.
(a) No manufacturer or wholesaler shall
distribute prescription drugs directly to a consumer or a patient, or operate
in such a manner as to endanger the public health.
(b) Any person who manufactures, wholesales, or
otherwise distributes prescription drugs, according to RSA 318:51-a and the
provisions of Ph 1000, shall be subject to disciplinary action as provided in
RSA 318:29.
Source.
#12007, eff 10-22-16 (formerly Ph 309.14)
Ph 1002.12 Reporting Changes.
(a)
It shall be the responsibility of the manufacturer or wholesaler to
immediately notify the board of any changes of information submitted in the
application for licensure.
(b)
Failure to provide the board with notification of changes in the
application contents, within 30 days of such changes, shall subject the
licensee, after notice and opportunity to be heard pursuant to Ph 200, to a
fine of $150.00.
(c)
The deadline for renewal applications shall be midnight June 30th
of every even-numbered year. Any
application received after that date shall be subject to a $25.00 reinstatement
fee. Licenses shall not be issued until
the late fee is satisfied. Licensees
shipping to or doing business in New Hampshire with an expired license shall be
subject to discipline by the board pursuant to RSA 318:55.
(d)
If the ownership at the customer service level has changed, the name of
the business has changed or more than 50% of the stock ownership has changed
hands then a new application shall be required.
(e)
If a manufacturer, wholesaler, or distributor has any license or permit
revoked, suspended, or voluntarily surrendered, the facility shall notify the
board within 7 days and include a copy of the corresponding documentation.
Source.
#12007, eff 10-22-16; ss by #13117, eff 10-15-20
Ph
1002.13 Discontinuance of Business.
(a) Any licensee that intends to cease business
activity shall inform the board, in writing, no less than 30-days prior to the
anticipated closing.
(b) If the records of receipt and disposition are
maintained electronically, a complete record of transactions, for the current 2
year period, shall be reduced to printed form prior to the actual close of
business.
Source.
#12007, eff 10-22-16
Ph
1002.14 Disposition of Drugs and
Records.
(a) The balance of any inventory of
non-controlled drugs may be sold to another wholesaler or manufacturer with
invoices available to each party and a copy for the board’s files.
(b) The remaining balance of any controlled drugs
may be transferred or sold to another wholesaler / manufacturer as a package
along with:
(1) A hard copy
record of the receipt and distribution of controlled substances for the past 2
years;
(2) All CII
drugs shall be transferred by DEA Form 222;
(3) All CIII –
V drugs shall be transferred by invoice with copies to the applicable parties
and to the board;
(4) The last 2
completed Biennial Inventory forms;
(5) All unused
DEA 222 forms shall be returned to the DEA, along with the current DEA
registration, marked VOID; and
(6) The current
NH manufacturer – wholesaler license shall be relinquished to the board.
Source.
#12007, eff 10-22-16
Ph
1002.15 Distributing Adulterated or
Misbranded Drugs.
(a) A wholesaler or distributor shall not
distribute any drug which is adulterated or misbranded. After notice and opportunity for a hearing, a
wholesaler, distributor who is found by the board to have knowingly distributed
or otherwise sold for consumption an adulterated or misbranded drug, shall be
subject to disciplinary action according to RSA 318:29.
Source.
#12007, eff 10-22-16
CHAPTER Ph 1100
COLLABORATIVE PHARMACY PRACTICE
PART Ph 1101
PURPOSE
Ph
1101.01 Purpose. The purpose of this chapter is to implement
and regulate collaborative pharmacy practice as a means to make the provision
of certain aspects of health care more efficient, less costly, and provided in
a more timely manner.
Source.
#9381, eff 1-31-09, EXPIRED: 1-31-17
New. #12464, eff 1-23-18
PART Ph 1102
DEFINITIONS
Ph
1102.01 “Attending practitioner” means
“attending practitioner” as defined in RSA 318:1, XXV, namely, “the physician
or advanced practice registered nurse who has the primary responsibility for
the treatment and care of the patient” and as outlined in the collaborative
agreement.
Source.
#9381, eff 1-31-09, EXPIRED: 1-31-17
New. #12464, eff 1-23-18
Ph
1102.02 “Collaborative pharmacy
practice” means “collaborative pharmacy practice” as defined in RSA 318:1,
XXVI, namely, “the practice of pharmacy whereby one or more pharmacists jointly
agree, on a voluntary basis, to work in conjunction with one or more attending
practitioners under written protocol whereby the collaborating pharmacist or
pharmacists may perform medication therapy management authorized by the
attending practitioner or practitioners under certain specified conditions and
limitations.”
Source.
#9381, eff 1-31-09, EXPIRED: 1-31-17
New. #12464, eff 1-23-18
Ph
1102.03 “Collaborative pharmacy practice
agreement'' means “collaborative pharmacy practice agreement'' as defined in
RSA 318:1, XXVII, namely, “a written and signed specific agreement between a
pharmacist and an attending practitioner that provides for collaborative
pharmacy practice for the purpose of medication therapy management for the
patient.” The term includes each
protocol developed pursuant to RSA 318:16-a, II(a).
Source.
#9381, eff 1-31-09, EXPIRED: 1-31-17
New. #12464, eff 1-23-18; ss by #13670, eff
8-20-23
Ph
1102.04 “Board” means “board” as defined
in RSAA 318:1, III.
Source.
#9381, eff 1-31-09, EXPIRED: 1-31-17
New. #12464, eff 1-23-18
PART Ph 1103
COLLABORATIVE PHARMACIST QUALIFICATIONS AND APPLICATION
Ph
1103.01 Qualifications.
(a) A pharmacist who seeks to engage in
collaborative practice shall:
(1) Hold an
unrestricted and current license to practice as a pharmacist in New Hampshire;
(2) Have at
least $1,000,000.00 of professional liability insurance that covers services
performed under a signed, written collaborative agreement;
(3) Have the
knowledge to properly perform the duties in the collaborative agreement; and
(4) Depending
on the complexity of services to be provided by the pharmacist the board shall
require additional education credits to meet the needs of the collaborative
practice agreement.
Source.
#9381, eff 1-31-09, EXPIRED: 1-31-17
New. #12464, eff 1-23-18
Ph
1103.02 Attending Practitioner
Qualifications. Pharmacists shall not enter into a collaborative agreement
with any other practitioner unless that practitioner:
(a) Holds an active, unrestricted license to
practice in the state of New Hampshire;
(b) Has prescriptive authority granted by a New
Hampshire licensing board; and
(c) Authorizes the pharmacist to perform only
those services that fall within that practitioner’s scope of practice.
Source.
#9381, eff 1-31-09, EXPIRED: 1-31-17
New. #12464, eff 1-23-18
PART Ph 1104
APPLICATION AND SUPPORTING DOCUMENTATION
Ph
1104.01 Application.
(a) A pharmacist who seeks to engage in
collaborative practice shall submit:
(1) A completed
and signed “Collaborative Practice Application”, effective December 2017 and
available on the board’s website;
(2) A certificate of insurance from the pharmacist’s
professional liability carrier indicating that the pharmacist maintains
insurance coverage that complies with RSA 318:16-a, I(b), and covers the duties
and responsibilities within the collaborative agreement; and
(3) A copy of
the collaborative agreement, as well as detailed information on the quality
assurance program required by RSA 318:16-a, IV (c).
(b) A pharmacist who seeks to engage in the
administration of vaccines shall hold current basic or higher certification in
cardiopulmonary resuscitation (CPR) from the American Heart Association, the
American Red Cross, or from another organization or entity that is nationally
recognized as an issuer of such certifications.
(c) After receipt of a “Collaborative Pharmacy
Practice Application” the board’s staff shall review it for any apparent errors
or omissions and inform the applicant in writing if any are found. If informed of errors or omissions, the
pharmacist shall correct the error or provide the missing application materials
within 30 days of such notification being sent.
(d) Pharmacists engaged in collaborative practice
shall provide written or electronic notification to the board of any change to
the original application or supporting documentation within 15 days of such
change taking effect.
Source.
#9381, eff 1-31-09, EXPIRED: 1-31-17
New. #12464, eff 1-23-18 (from Ph 1103.02); amd by
#13007, EMERGENCY RULE, eff 3-20-20, EXPIRED: 9-16-20 (in
para (b), and (b) in #12464 effective again pursuant to RSA 541-A:18, V)
PART Ph 1105
COLLABORATIVE PRACTICE AGREEMENTS AND INFORMED CONSENT
Ph
1105.01 Collaborative Practice
Agreements.
(a) Collaborative practice agreements shall
describe in detail services that a pharmacist may perform for a patient,
including but not limited to:
(1)
Specific drugs to be managed by the pharmacist;
(2) Terms and conditions under which a
drug therapy may be implemented, modified, or discontinued;
(3)
Conditions and events upon which the pharmacist is required to notify
the collaborating practitioner, and the manner and time frame in which such
notification shall occur;
(4)
The laboratory tests that may be ordered to manage a medication therapy;
(5)
Activities which may be performed by the pharmacist in conjunction with
a written protocol;
(6)
A statement of the expected amount of dedicated time that a pharmacist
will use exclusively to perform duties in the collaborative agreement;
(7)
Documentation of the care delivered and, if applicable, methods of
communication of essential information the patient’s other health care
providers;
(8)
Education and training designed to enhance patient understanding and the
appropriate use of his or her medication;
(9)
The beginning and ending dates of the period of time during which the
agreement is in effect;
(10)
A statement that the agreement may be terminated in writing by either
party at any time, subject to (c) below; and
(11)
A description of the private, HIPAA-compliant space to be utilized for
collaborative practice.
(b) Collaborative agreements shall be renewed at
least every 2 years and signed by all practitioners who are a party to the
agreement.
(c) When a collaborative agreement between the
pharmacist and the practitioner is terminated, the pharmacist shall provide
notification to the patient and document in the electronic medical record. Such notification shall include detailed
information on how the patient may continue any medication therapy provided by
the pharmacist without interruption.
(d) Collaborative practice agreements shall
include quality metrics developed by pharmacist(s) and practitioners.
(e) Pharmacists shall keep a copy of each
collaborative agreement, including any protocols specified in such agreements,
to which they are a party at their place of practice.
(f) Collaborative agreements and protocols shall
be available for inspection and review by the board or its agents at any time
during the pharmacist’s normal business hours.
Source.
#12464, eff 1-23-18 (from Ph 1104.01); ss by #13670, eff 8-20-23
Ph
1105.02 Practice Under a
Collaborative Practice Agreement.
(a) Practice by a pharmacist under a
collaborative practice agreement shall not be delegable and shall be performed
only by the pharmacist who is a party to the agreement.
(b) At least once per year, the pharmacist shall
review the collaborative practice agreement and each protocol developed
pursuant thereto so as to determine whether changes should be made to reflect
the standard of care. If such a review
reveals that a change should be made, the pharmacist shall inform the attending
practitioner.
(c) Nothing in this chapter shall be construed to
prohibit an authorized pharmacist from participating in medication therapy
management by protocol or policy approved by the medical staff of the hospital,
so long as such participation is limited to drugs administered to a patient by
an individual licensed to administer the drug to the patient in an in-patient
or outpatient hospital setting.
(d) Nothing in this chapter shall be construed to
prohibit a pharmacist from performing medication therapy management services
that do not require a collaborative agreement, such as:
(1)
Performing patient assessment or comprehensive medication review;
(2)
Formulating a medication treatment plan;
(3)
Monitoring efficacy and safety of medication therapy;
(4)
Enhancing medication adherence through patient empowerment and
education; and
(5)
Documenting and communicating medication therapy management services to
prescribers in order to maintain comprehensive patient care.
(e) In the event the board places a restriction
on a pharmacist license, that pharmacist shall cease working under any
collaborative agreement immediately upon being restricted. Once the restriction has been removed by the
board, the pharmacist may reapply for collaborative practice as described in Ph
1105.01.
(f) In the event a licensing board places a
restriction on an attending practitioner, the pharmacist shall cease working
under any collaborative agreement with that attending practitioner. Once the restriction has been removed by the
respective licensing board, the pharmacist may reapply for collaborative
practice with that attending practitioner.
Source.
#12464, eff 1-23-18 (from Ph 1104.03); ss by #13670, eff 8-20-23
(formerly Ph 1105.03)
Ph
1105.03 Audits.
(a) The board shall, at its annual January
meeting, randomly select at least 10 percent and not more than 20 percent of
active collaborative agreements for an audit.
(b) The continuing education advisory council
shall audit the continuing education requirements of randomly selected
collaborative practice agreements and submit its finding to the board at its
annual April board meeting.
(c) Audits shall include the elements outlined in
Ph 1104.
(d) Violations discovered by an audit shall be
reported to the board.
Source. #12464, eff 1-23-18; ss by #13670, eff
8-20-23 (formerly Ph 1105.04)
CHAPTER Ph 1200
CENTRAL PRESCRIPTION PROCESSING
PART Ph 1201
PURPOSE AND SCOPE
Ph
1201.01 Purpose. The purpose of this chapter is to set forth
the requirements, limitations, and prohibitions for pharmacies that engage in
central prescription processing so as to ensure that, for the protection of the
public, all central prescription processing activities regulated by the board
are performed in compliance with applicable state law and rules by those who
are licensed by the board.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1201.02 Scope. This chapter shall apply to all persons whose
activities come under the jurisdiction of
the board and who engage in central prescription processing activities.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
PART Ph 1202
DEFINITIONS
Ph 1202.01 “Central
fill pharmacy” means a licensed pharmacy, in this or any other state,
district or commonwealth of the United States, engaging in central prescription
handling by filling, refilling, or both, prescriptions including the
preparation, packaging, and labeling of the medication.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph 1202.02 “Central
prescription processing” means “central prescription processing” as defined in RSA
318: 1, XXIII, namely, “the processing by a pharmacy of a request from another
pharmacy to fill or refill a prescription drug order or to perform processing
functions, such as dispensing, drug utilization review, claims adjudication,
refill authorizations, and therapeutic interventions.”
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph 1202.03 “Central
processing pharmacy” means a licensed pharmacy, in this or any other
state, district, or commonwealth of the United States, that engages in
prescription review by performing functions that include but are not limited
to:
(a) Data entry;
(b) Prospective drug review;
(c) Refill authorizations;
(d) Therapeutic interventions;
(e) Patient counseling;
(f) Claims submission;
(g) Claims resolution; and
(h) Claims adjudication.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1202.04 “Claims adjudication” means
the process by which a prescription is submitted and processed through a
third-party payor.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1202.05 “Dispensing pharmacy” means a licensed pharmacy, in this or any
other state, district or commonwealth of the United States, that receives the
processed prescription, the filled or refilled prescription, or both, for
dispensing to the patient or to the patient’s authorized representative and
providing patient counseling as required.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph 1202.06 “Intake
pharmacy” means a licensed pharmacy, in this or any other state,
district or commonwealth of the United States, that receives the patient’s or
prescribing practitioner’s request to fill or refill a prescription, including
a central processing pharmacy or a central fill pharmacy, as defined below, if
the prescription was transmitted by the prescribing practitioner directly to
such pharmacy or if the patient requested the refill from that pharmacy.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
PART Ph 1203
CENTRAL PRESCRIPTION PROCESSING
Ph
1203.01 General Requirements for
Engaging in Central Prescription Processing. A pharmacy may perform or outsource central
prescription processing and handling services provided that:
(a) All pharmacies involved in the transactions
pursuant to which the prescription is dispensed shall have either:
(1) The same owner; or
(2) A written contract outlining the services to be provided and the
responsibilities and accountabilities of each party in fulfilling the terms of
the contract in compliance with federal and state laws, regulations, and rules;
(b) The pharmacies shall share a database to
allow access to information necessary or required to fill or refill a
prescription drug order;
(c) All participating pharmacies located in this
state shall maintain a pharmacy license for each location or if located in
another state shall be registered in New Hampshire as a mail-order pharmacy
according to Ph 900;
(d) All pharmacists participating in, providing,
or both, central prescription processing services shall be licensed in this
state or in the case of a non-resident pharmacy, the state in which the
pharmacy is located; and
(e) Each pharmacy and pharmacist engaging in
central prescription processing and handling shall be responsible for properly
filling the prescription and complying with the requirements of Ph 706 or each
relevant and applicable provision adopted by the state in which the pharmacy or
pharmacist is registered or licensed. If
such other state does not have a relevant or applicable provision, the owner or
contract referred to in (a) above shall comply with or require compliance with
the substance of Ph 706.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1203.02 Policy and Procedure Manual
Required.
(a) Each participating pharmacy performing or
contracting for the performance of centralized prescription processing and
handling shall maintain a paper or electronic policy and procedure manual that
includes at least the following:
(1) A policy that shall require
every participating intake pharmacy to keep a record that includes at least the
name, address and DEA number for each central fill or central processing pharmacy authorized to fill or process
prescriptions on its behalf;
(2) A policy that shall require each
central fill or central processing pharmacy to keep a record that includes at
least the name, address and DEA number of all intake pharmacies for which it is
authorized to fill or process prescriptions;
(3) A policy that shall describe
comprehensively the responsibilities of each of the participating intake,
filling, processing and dispensing pharmacies;
(4) A procedure that shall be used
for maintaining records sufficient to allow for tracking a prescription during
each stage of the filling and dispensing process including at least:
a. The following information about
the pharmacist(s) and technician(s) involved in filling and dispensing the
prescription and counseling the patient:
1. The pharmacist’s full name;
2. The state in which the pharmacist
is licensed and his or her license number; and
3. The action or actions taken by
the pharmacist; and
b. The following information about
the technician(s) involved in filling and dispensing the prescription:
1. The technician’s full name;
2. The state in which the technician
is licensed and the license number; and
3. The action or actions taken by
the technician;
(5) The policy and procedure that
shall be used for providing adequate security to protect the confidentiality
and integrity of patient information;
(6) The procedure that shall be used
by the pharmacy in implementing and operating a quality assurance program
designed to objectively and systematically monitor, evaluate, and improve the
quality and appropriateness of patient care; and
(7) The procedure that shall be
followed in dispensing a prescription drug order when the filled order is not
received or the patient comes in before the order is received.
(b) Each participating pharmacy and pharmacist
shall review the policies and procedures at least annually and such review
shall be documented.
(c) Each participating intake, processing,
filling and dispensing pharmacy and pharmacist shall make the policies and
procedures manual available to the board or its agents upon request.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1203.03 Patient Counseling. The dispensing pharmacy shall offer to counsel to the patient as required
pursuant to Ph 706.03.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1203.04 Prohibitions and Limitations.
(a) Prescriptions
for Schedule II controlled substances shall not be allowed for central
prescription filling but shall be filled and dispensed at the intake
pharmacy.
(b) Prescriptions for
Schedule III, IV, or V controlled substances shall be allowed for central
prescription processing and
filling.
(c) Prescriptions for legend or controlled
substances listed in Schedule III, IV, or V may be transmitted electronically, as permitted by state
and federal laws, including via facsimile, from an intake pharmacy to a central
fill pharmacy, provided that the intake pharmacy transmitting the prescription
information complies with all state and federal laws.
(d) An intake pharmacy transmitting prescription
information pursuant to (c) above shall keep:
(1) Records that track the
prescription drug order during each step in the filling process that shall
identify the name(s), initials, or identification code(s) and specific
activity(ies) of each pharmacist or pharmacy
technician who performed any portion of the process, including:
a. Transmission;
b. Filling;
c. Dispensing; or
d. Delivery to either the patient or
another pharmacy; and
(2) A record of the date the filled
prescription was delivered to the intake pharmacy, the method of delivery, such
as by private, common or contract carrier, and the identity of the carrier.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
Ph
1203.05 Record Keeping.
(a) The common electronic database shall maintain
a record of all pharmacists and pharmacies involved in the intake, processing,
filling, and dispensing of all prescriptions.
(b) There shall be record keeping systems between
central prescription processing pharmacies with real-time, online access to
those services provided by each pharmacy.
(c) Access to prescription information by 2
participating pharmacies shall not be considered a prescription transfer and
shall not be subject to the provisions of Ph 704.04.
(d) All records required to be created and
maintained pursuant to Ph 1203 shall be maintained for a period of not less
than 4 years.
Source.
#9469, eff 5-16-09, EXPIRED: 5-16-17
New. #12485, eff 2-24-18
CHAPTER Ph 1300 PHARMACIST ADMINISTRATION OF VACCINES
PART Ph 1301 PURPOSE AND SCOPE
Ph
1301.01 Purpose. The purpose of this chapter is to implement
and regulate administration of vaccines by a pharmacist, pharmacy intern,
licensed advanced pharmacy technician, and certified pharmacy technician as a
means to make vaccinations more easily accessible and therefore providing
immunity to a larger patient population.
Source.
#9552, eff 9-23-09; ss by #10185, eff 9-18-12; ss by #13558, eff 4-12-23
Ph
1301.02 Scope. These rules shall regulate administration of
vaccines where the practice of pharmacy is permitted.
Source.
#9552, eff 9-23-09; ss by #10185, eff 9-18-12; ss by #13558, eff 4-12-23
PART Ph 1302 DEFINITIONS
Ph
1302.01 “Administer” means “administer”
as defined in RSA 318:1, I, namely, “an act whereby a single dose of a drug is
instilled into the body of, applied to the body of, or otherwise given to a
person or animal for immediate consumption or use.”
Source.
#9552, eff 9-23-09; ss by #10185, eff 9-18-12; ss by #13558, eff 4-12-23
Ph 1302.02 “Certified pharmacy technician” means a pharmacy technician who has become and who maintains national
certification by taking and passing an exam recognized by the board for the
purpose of certifying technicians, as specified in Ph 808.01(a)(3), and who has
been certified by the board pursuant to Ph 808.
Source. #13558, eff 4-12-23
Ph
1302.03 “Licensed pharmacist” or
“pharmacist” means “licensed pharmacist” or “pharmacist” as defined in RSA
318:1, VII, namely, “when not otherwise limited, means a person holding a
license under RSA 318:18 and who is, therefore legally authorized to practice
the profession of pharmacy in this state.”
Source.
#9552, eff 9-23-09; ss by #10185, eff 9-18-12; ss by #13558, eff 4-12-23
(formerly Ph 1302.02)
Ph
1302.04 “Pharmacy intern” means
“pharmacy intern” as defined in RSA 318:1, XI-aa, namely, “a person who is registered by the board pursuant to
RSA 318:15-b” and:
(a) Is enrolled in a professional degree program
of a school or college of pharmacy accredited by the Accreditation Council of
Pharmacy Education and is satisfactorily progressing toward meeting the
requirements for licensure as a pharmacist starting no earlier than 4 months
prior to the third year of study;
(b) Is a graduate of
an approved professional degree program of a school or college of pharmacy or
is a graduate who has established educational equivalency by obtaining a
Foreign Pharmacy Graduate Examination Committee (FPGEC) Certificate, who is
currently licensed by the board of pharmacy for the purpose of obtaining
practical experience as a requirement for licensure as a pharmacist;
(c) Is a qualified applicant awaiting examination for
licensure or meeting board requirements for re-licensure; or
(d) Is participating
in a residency or fellowship program.
Source. #13558, eff 4-12-23
Ph
1302.05 “Practitioner” or “licensed
practitioner” means “practitioner” or “licensed practitioner” as defined in RSA
318:1, XV, namely, “means any person who is lawfully entitled to prescribe,
administer, dispense, or distribute legend drugs to patients.”
Source.
#9552, eff 9-23-09; ss by #10185, eff 9-18-12; ss by #13558, eff 4-12-23
(formerly Ph 1302.03)
PART Ph 1303
ADMINISTRATION OF VACCINES QUALIFICATIONS AND APPLICATION
Ph 1303.01 Qualifications.
(a) A pharmacist, pharmacy intern, licensed
advanced pharmacy technician, or certified pharmacy technician as authorized by
RSA 318:16-b who seeks to engage in the administration of vaccines shall meet
the requirements of:
(1) RSA
318:16-b, I, relative to education or experience;
(2) RSA
318:16-b, II, relative to professional liability insurance coverage; and
(3) RSA
318:16-b, III, relative to completion of continuing education.
(b) A pharmacist, pharmacy intern, licensed
advanced pharmacy technician, or certified pharmacy technician as authorized by
RSA 318:16-b who seeks to engage in the administration of vaccines shall hold
current basic or higher certification in cardiopulmonary resuscitation (CPR)
from the American Heart Association, the American Red Cross, or from another
organization or entity that is nationally recognized as an issuer of such
certifications.
(c) A pharmacy intern, licensed advanced
pharmacy technician, or certified pharmacy technician as authorized by RSA 318:16-b who is
administering vaccines shall be supervised by an onsite supervising pharmacist
who is licensed with the board to administer vaccines.
Source.
#9552, eff 9-23-09; ss by #10185, eff 9-18-12; amd by #13007, EMERGENCY
RULE, eff 3-20-20, EXPIRED: 9-16-20 (in para (b), and (b) in #12464 effective
again pursuant to RSA 541-A:18, V); EXPIRED: 9-18-22
New. #13558, eff 4-12-23 (formerly Ph 1302.03)
Ph 1303.02 Application. A pharmacist, pharmacy intern, licensed
advanced pharmacy technician, or certified pharmacy technician who seeks to
engage in the administration of vaccines shall file a completed “Pharmacist,
Pharmacy Intern, Licensed Advanced Pharmacy Technician, and Certified Pharmacy
Technicians Application to Administer Vaccines Form” revised 11/2022 as
specified in RSA 318:16-b, IV.
Source.
#9552, eff 9-23-09; ss by #10185, eff 9-18-12; ss by #10842, eff 6-3-15;
ss by #13558, eff 4-12-23
PART Ph 1304
ADMINISTRATION OF VACCINES PROCEDURAL AND RECORDKEEPING REQUIREMENTS
Ph
1304.01 Vaccine Administration
Requirements. A pharmacist, pharmacy
intern, licensed advanced pharmacy technician, or certified pharmacy technician
who engages in the administration of vaccines shall comply with the following
procedures:
(a) Provide the patient with a “Vaccine
Information Statement (VIS)” or equivalent information if the vaccine is
authorized under an Emergency Use Authorization (EUA), as provided by the
Centers for Disease Control (CDC);
(b) Ensure that the patient has received and
signed the “Patient Consent Form” inclusive of electronic forms of
communication and consent, and has been counseled and their questions answered
prior to administration of the vaccine;
(c) Maintain and follow written policies and
procedures that establish a course of action the pharmacist shall follow to
address:
(1) Adverse
reactions;
(2)
Anaphylactic reactions including a standard order for treatment;
(3) Accidental
needle sticks; and
(4) Both the
handling and disposal of used or contaminated equipment and supplies;
(d) Report all adverse events to the Vaccine
Adverse Events Reporting System (VAERS) and to the primary care physician if
applicable;
(e) Provide the patient with documentation of the
vaccination and when appropriate report it to the immunization section of the
New Hampshire department of health and human services to be added to the
Vaccination Registry;
(f) Provide notice electronically, in writing, or
fax to the primary care provider, when designated by the patient, of the
administration of the vaccine; and
(g) Be able to recognize anaphylaxis and maintain
at least 2 doses of injectable epinephrine at all times to treat a reaction if
it occurs.
Source.
#9552, eff 9-23-09; ss by #10185, eff 9-18-12;
ss by #13558, eff 4-12-23
Ph
1304.02 Recordkeeping. A pharmacist who engages in the
administration of vaccines shall, for a minimum of 4 years, keep a patient
consent form that includes the:
(a) Name and date of birth of the patient;
(b) Name of the vaccine, manufacturer, lot
number, and expiration date of the vaccine;
(c) Indication that the patient understands there
are risks and possible side effects of the vaccine;
(d) Date of administration;
(e) Vaccine administrator’s name;
(f) Name of pharmacist overseeing the
administration by pharmacy interns, licensed advanced pharmacy technicians, or
pharmacy technicians as authorized by RSA 318:16-b; and
(g) Signature of the patient.
Source.
#9552, eff 9-23-09; ss by #10185, eff 9-18-12; ss by #13558, eff 4-12-23
CHAPTER Ph 1400 REPEALED
CHAPTER Ph
1500 REPEALED
CHAPTER Ph 1600 PHARMACY INTERNS
PART Ph 1601 PURPOSE AND SCOPE
Ph 1601.01 Purpose and Scope. The provisions of
this chapter shall apply to, and impose duties upon, all pharmacy interns
holding registrations issued by the board.
Source.
#10721, eff 11-22-14; ss by #12670, eff 11-17-18
PART Ph 1602 DEFINITIONS
Ph
1602.01 Definitions. Except where
the context makes another meaning manifest, the following definitions shall
apply:
(a)
“Registered pharmacy intern” means a person:
(1)
Who is enrolled in a
professional degree program of a school or college of pharmacy that has been
approved by the board and is satisfactorily progressing toward meeting the
requirements for licensure as a pharmacist;
(2)
Who is a graduate of an
approved professional degree program of a school or college of pharmacy or is a
graduate who has established educational equivalency by obtaining a Foreign
Pharmacy Graduate Examination Committee (FPGEC) certificate, who is currently
licensed by the board of pharmacy for the purpose of obtaining practical
experience as a requirement for licensure as a pharmacist;
(3) Who is a
qualified applicant awaiting examination for licensure or meeting board
requirements for re-licensure; or
(4)
Who is participating in a residency or fellowship, except individuals
that hold an active license to practice pharmacy in the State of New Hampshire.
Source.
#10721, eff 11-22-14; ss by #12670, eff 11-17-18
PART Ph 1603 IDENTIFICATION
Ph
1603.01 Identification. The
pharmacy intern shall be so designated in his or her professional
relationships, and shall in no manner falsely assume, directly or by inference,
to be a pharmacist. The board shall issue to the pharmacy intern a registration
for purposes of identification and verification of his or her role as a
pharmacy intern, which registration shall be surrendered to the board upon
discontinuance of pharmacy practice experiences for any reason including
licensure as a pharmacist. Only individuals properly registered by
the board as a pharmacy intern shall take, use, or exhibit the title of
pharmacy intern, or any other term of similar like or import.
Source.
#10721, eff 11-22-14; ss by #12670, eff 11-17-18
PART Ph 1604 REGISTRATION
Ph
1604.01 Application.
(a) No person shall perform the functions or
duties of a pharmacy intern unless such person is registered by the board.
(b) Application form “Pharmacy Intern Initial
Registration Form” for registration of pharmacy interns in New Hampshire may be
obtained from and shall be filed at the office of the board, identified in Ph
103.03.
(c) Each applicant shall provide the following on
form PI-1:
(1)
Name, gender, current mailing address, and home telephone number;
(2)
Social security number, date of birth, and email address;
(3)
Name and address of the college or university where currently enrolled
in, or graduated from, the pharmacy program;
(4)
Anticipated date of graduation from accredited pharmacy program;
(5)
Record of convictions of violations of federal, state, or local drug or
pharmacy- related laws or regulations;
(6)
An indication as to whether the applicant is or ever has been registered
or licensed as a pharmacy intern in New Hampshire or any other state and, if
so, an indication as to which state(s) and whether such registration or license
is currently valid;
(7)
An indication as to whether the applicant has ever voluntarily
surrendered his or her pharmacy intern registration in this or any other state
or jurisdiction and, if so, an explanation of such surrender; and
(8)
Applicant’s signature and date.
(d) The applicant shall submit with application
form PI-1, the prescribed fee of $25.
(e) An applicant for registration as a registered
pharmacy intern shall meet the following requirements:
(1)
Be at least 18 years of age;
(2) Be enrolled in or possess a pharmacy
degree from an accredited college or university pharmacy program;
(3)
Be of good moral character,
as demonstrated by the information provided by the applicant on the
registration form and any attachments; and
(4)
Has not been convicted of
a felony or a misdemeanor resulting from a violation of any federal, state, or
local drug or pharmacy-related law, rule, or regulation.
Source.
#10721, eff 11-22-14; ss by #12670, eff 11-17-18
PART Ph 1605 REGISTRATIONS – CHANGES IN SUPPORTING DATA
Ph
1605.01 Reporting Changes.
(a) The person to whom a pharmacy intern
registration has been issued shall notify the board within 15 days if a change
of one or more of the following occur:
(1)
Name;
(2)
Address;
(3) Transfer of enrollment from accredited
college or university pharmacy program to another; or
(4)
Permanent separation of enrollment from his or her accredited pharmacy
program, not to include graduation.
(b) The notice shall contain the following:
(1)
Name of the registrant;
(2)
Address of the registrant including old and new, if applicable;
(3)
Registrant’s registration number;
(4)
Name of the school of pharmacy attending, including former and current,
if applicable;
(5)
Graduation date or anticipated date of graduation from accredited
pharmacy program;
(6)
Certification status, if applicable; and
(7)
All new violations of law, convictions, fines, discipline or any
registration, certification or license revocations for violation of
pharmacy-related drug laws or regulations in this or any other state.
Source.
#10721, eff 11-22-14; ss by #12670, eff 11-17-18
PART Ph 1606 PHARMACY INTERNS – STANDARDS OF PRACTICE
Ph
1606.01 Responsibilities and Duties.
(a)
The pharmacist-in-charge shall identify pharmacy interns and assure that such
persons are registered with the board as pharmacy interns prior to employment
or experiential pharmacy rotation.
(b)
All pharmacy interns shall wear a name tag, identifying them as a
“Pharmacy Intern” while on duty.
(c) The pharmacist-in-charge shall determine the duties of each pharmacy
intern based upon the needs of the pharmacy and
experiential site.
(d) A pharmacy intern shall be allowed to engage
in all activities in the practice of pharmacy provided that such activities are
under the supervision of a pharmacist with the one exception of product
verification.
(e) A pharmacist shall be in contact with, and actually
giving instructions to, the pharmacy intern during all professional activities.
(f) Only pharmacy interns in their last professional year or graduates of an
approved professional degree program of a school or college of pharmacy or
graduates of an approved professional degree program of a school or college of
pharmacy or graduates who have established educational equivalency by obtaining
a Foreign Graduate Examination Committee (FPGEC) certificate may perform
product verification. Direct supervision
shall not be required for product verification.
Source.
#10721, eff 11-22-14; ss by #12670, eff 11-17-18
PART Ph 1607 REVOCATION AND DENIAL
Ph
1607.01 Effect of Revocation and
Denial.
(a) The board shall refuse to issue a
registration, or after notice and hearing, shall revoke a registration whenever
the board finds by the preponderance of the evidence any of the following:
(1)
That the applicant, or registrant, has willfully violated any of the
provisions of RSA 318 or Ph 1600;
(2) That the applicant has been convicted
of a felony or a misdemeanor resulting from a violation of any federal, state,
or local drug or pharmacy-related law, rule, or regulation;
(3) That the applicant has attempted to
obtain a pharmacy intern registration by fraudulent means;
(4)
That the applicant is unable to engage in the performance of pharmacy
intern functions with reasonable skill and safety by reason of illness,
inebriation, misuse of drugs, narcotics, alcohol, chemicals or any other
substance, or as a result of any mental or physical condition;
(5)
The suspension, revocation, or probation by another state of the
applicant’s license, permit, or registration to practice as a pharmacy intern;
(6)
That the applicant refused to appear before the board after having been
ordered to do so in writing; or
(7)
That the applicant made any fraudulent or untrue statement to the board.
(b) The pharmacist-in-charge or other staff
pharmacist shall notify the board, in writing, within 7 calendar days after
becoming aware that a pharmacy intern has adulterated, abused, stolen, or
diverted drugs.
(c) The board shall reinstate a registration
after review, provided that the reason for revocation no longer exists, or it
is determined that there is no longer a threat to public safety.
Source.
#10721, eff 11-22-14; ss by #12670, eff 11-17-18
PART Ph 1608 RENEWAL OF REGISTRATIONS
Ph
1608.01 Renewal Registrations
Required. All pharmacy intern registrations shall expire annually on
September 30.
Source.
#10721, eff 11-22-14; ss by #12670, eff 11-17-18
Ph 1608.02 Renewal Application Where Obtained and
Filed. Applications for the renewal
of a registration for a pharmacy intern shall be filed online at
https://nhlicenses.nh.gov/eGov/Login.aspx.
Source.
#10721, eff 11-22-14; ss by #12670, eff 11-17-18
Ph 1608.03 Renewal
Application Contents and When Filed.
Renewal applications shall be filed with the board in accordance with
the following:
(a)
Applications for renewal of pharmacy intern registration shall be made online
at https://nhlicenses.nh.gov/eGov/Login.aspx.
(b) Each applicant shall provide the following
information online as part of his or her renewal:
(1)
Original registration number;
(2)
Name, current mailing address, and home telephone number;
(3)
Social security number, date of birth, and email address;
(4)
Name and address of the college or university where currently enrolled
in, or graduated from, the pharmacy program;
(6)
Record of convictions of
violations of federal, state, or local drug or pharmacy-related laws or
regulations;
(7)
Applicant’s signature and date; and
(8)
Employment name, address, phone number, and the name of the supervisor
and pharmacist-in-charge;
(c)
The application and the prescribed fee of $25 shall be filed with the
board no later than September 30.
Source.
#10721, eff 11-22-14; ss by #12670, eff 11-17-18
Ph 1608.04 Reinstatement.
(a) A registered intern’s
failure to renew his or her registration by September 30 shall result in a
lapsed registration.
(b) Any intern that wishes
to reinstate a lapsed license shall do so by completing and submitting an
“Intern Reinstatement Application”, effective October 2018 and available on the
board’s website at www.oplc.nh.gov/pharmacy.
(c) A reinstatement
applicant shall also submit a dated and signed letter explaining why he or she
allowed his or her registration to lapse and an indication as to whether he or
she practiced as a pharmacy intern with a lapsed registration.
Source.
#12670, eff 11-17-18
CHAPTER Ph 1800
LICENSED ADVANCED PHARMACY TECHNICIANS
PART Ph 1801 PURPOSE AND SCOPE
Ph 1801.01 Purpose. Utilization of a licensed advanced pharmacy
technician is intended to increase the availability of the pharmacist for
involvement in cognitive and patient care services.
Source. #13463, eff 10-18-22
Ph1801.02 Scope.
The provisions of this chapter shall apply to, and impose duties upon,
all licensed advanced pharmacy technicians holding licenses issued by the
board.
Source. #13463, eff 10-18-22
PART Ph 1802 DEFINITIONS
Ph 1802.01 Definitions.
(a)
“Drug preparation” means to prepare or approve a medication for
dispensing when preparation is done according to manufacturer’s instructions
provided in the current Federal Food and Drug approved package insert.
(b) “Licensed advanced pharmacy technician” means a person licensed by the board who:
(1) May perform all functions
allowed by federal or state law and approved by the board, under the
supervision of a licensed pharmacist who is physically on premises and holds an
unrestricted license issued by the board;
(2) May conduct product
verification, process refills, verify repackaging of drugs, and perform other
pharmacist tasks not required to be completed by a licensed pharmacist;
(3) May perform duties allowed
by either certified or registered pharmacy technicians;
(4) Shall not interpret or
evaluate a prescription or drug order, verify a compounded drug, or counsel or
advise individuals related to the clinical use of a medication.
(c)
“Product verification” means the physical act of validating the correct
drug, strength, and form of the drug product being dispensed.
(d)
“Verification error” means the dispensing of a prescribed medication
that passes the product verification step with the incorrect drug, strength, or
form.
Source. #13463, eff 10-18-22
PART Ph 1803 INITIAL LICENSE
Ph 1803.01 Initial Application for Pharmacy Technician.
(a)
The “Licensed Advanced Pharmacy Technician Initial Application” form
PT-21 described in (d) below, for licensure to practice as an advanced pharmacy
technician in the State of New Hampshire may be obtained from and shall be completed and submitted to
the office of OPLC Office of Professional Licensure and Certification (OPLC),
identified in Ph 103.03.
(b) An applicant for licensure as an advanced
pharmacy technician shall meet the following requirements:
(1) Have worked 2,000 hours as a certified
pharmacy technician in good standing, attested to by a NH licensed
pharmacist(s) in good standing;
(2) Have successfully completed 4 advanced
technician assessment based programs provided
by a nationally recognized certification provider consisting of:
a. Two
assessment based programs on product verification and immunization
administration;
b. Two assessment based programs on any of the
remaining assessment based programs; and
(3) Have successfully passed a jurisprudence
exam approved by the board.
(c)
A technician whose duties include product verification and who meets all
of the qualifications listed in (b) above shall complete training on product
verification:
(1) At the technician’s practice setting or when changing the technician’s practice setting with a
licensed pharmacist; and
(2) That includes the use of drug identification resources.
(d)
Applicants for licensure shall
submit:
(1) The “Licensed Advanced
Pharmacy Technician Initial Application” form containing the following:
a. Full legal name;
b. Date of birth;
c. Residence address;
d. Mailing address;
e. Home or cell phone number;
f. Personal e-mail address;
g. Social security number, as required by RSA
161-B:11, VI-a;
h. Name of current employer including the mailing address, phone
number, and e-mail address of the employment site;
i. An indication as to whether or not the applicant has been
convicted of a felony or admitted to sufficient facts to warrant such a
finding, and if yes, an explanation of the circumstances surrounding such a
finding or conviction;
j. An indication as to whether the applicant has ever voluntarily
surrendered for disciplinary reasons a license, registration, or certification
to practice as a pharmacist or pharmacy technician in any jurisdiction and, if
so, an explanation of such surrender;
k. An attestation that the applicant has met the
requirement for hours worked as a certified pharmacy technician set forth in
(c) above; and
l. The applicant's signature and date; and
(2) A fee of $100 made payable to Treasurer,
State of NH.
Source. #13463, eff 10-18-22
Ph 1803.02 Processing of Applications.
(a) If the board, after receiving and reviewing
an initial application and fee, requires further information or documents to
complete the application and determine the applicant's qualification for
licensure, the board shall:
(1) So notify the applicant in
writing within 30 days; and
(2) Specify the information or
documents it requires.
(b) The board shall issue written approval or
denial of an application within 60 days of the date that the application is
complete.
(c)
The board shall issue a denial of licensure if the board finds a
violation of Ph 1805.01 which would impair the applicant’s ability to practice.
(d) The fee shall be non-refundable:
(e) Any applicant wishing to challenge the
board's denial of an application for initial licensure shall:
(1) Make a written request for
a hearing of the applicant's challenge; and
(2) Submit this request to the
board:
a. Within 60 days of the
board’s notification of denial; or
b. If the applicant is on
active military duty outside the United States, within 60 days of the
applicant’s return to the United States or release from duty, whichever occurs
later.
Source. #13463, eff 10-18-22
PART Ph 1804 ONGOING REQUIREMENTS
Ph 1804.01 Reporting Changes.
(a)
The person to whom a licensed advanced pharmacy technician license has
been issued shall, within 15 days of change of residential address or location of employment,
notify the board of such changes.
(b)
The notice in (a) above shall contain:
(1) The name of the licensee;
(2) The address of the licensee including old and
new, if applicable;
(3) The license number;
(4) The name of the pharmacy where employed
including former and current, if applicable; and
(5) All new violations of;
a. State or federal law including convictions
and fines; and
b. Disciplinary action taken against any
registration, certification, or license including revocations for violation of
pharmacy-related drug laws or regulations in this or any other state or
jurisdiction.
(c)
An advanced pharmacy technician shall maintain their national
certification while licensed as an advanced pharmacy technician by the board.
(d)
In the event a licensed advanced pharmacy technician loses
certification, he or she shall notify the pharmacist-in-charge immediately and
report to the board in writing within 15 days of the lapse of certification.
(e)
The pharmacist-in-charge shall notify the board, in writing, within 15
calendar days after becoming aware that a licensed advanced pharmacy technician has adulterated,
abused, stolen, or diverted drugs and include the name of the technician
involved.
Source. #13463, eff 10-18-22
PART Ph 1805 REVOCATION, SUSPENSION AND OTHER SANCTIONS
Ph 1805.01 Misconduct. Misconduct shall occur when:
(a)
A person performs the
functions or duties of a licensed advanced pharmacy technician without being
licensed by the board;
(b)
An advanced pharmacy technician acts as a licensed advanced practice
pharmacy technician without holding a current board
approved technician certification, described in Ph 1804.01(c), in good
standing;
(c)
The applicant, or licensee, has willfully violated any of the provisions
of RSA 318, RSA 318-B or the board’s rules;
(d)
The applicant has been convicted of any felony or misdemeanor resulting
from a violation of any federal, state, or local drug or pharmacy-related law,
rule or regulation;
(e)
The applicant has attempted to obtain a licensed advanced pharmacy
technician or pharmacy technician registration by fraudulent means;
(f)
The applicant is unable to engage in the performance of advanced
pharmacy technician or certified pharmacy technician functions with reasonable
skill and safety by reason of illness, inebriation, misuse of drugs, narcotics,
alcohol, chemicals, or any other
substance, or as a result of any mental or physical condition;
(g)
There is a suspension, revocation, or probation by another state of the
applicant’s license, permit, or registration to practice as a pharmacy
technician;
(h)
The applicant refuses to appear before the board after having been
ordered to do so in writing; or
(i)
The applicant makes any fraudulent or untrue statement to the board.
Source. #13463, eff 10-18-22
Ph 1805.02 Revocation, Suspension, or Nonrenewal of
National Certification.
(a)
Upon the revocation, suspension, or nonrenewal of the advanced pharmacy
technician’s national certification the advanced pharmacy technician shall
notify the board within 15 days of that action by the national certifying body.
(b)
The board upon notification by the advanced pharmacy technician of the
revocation, suspension, or nonrenewal of the national certification shall issue
a notice of hearing.
Source. #13463, eff 10-18-22
Ph 1805.03 Disciplinary Action and Sanctions. The board shall follow Ph 2207 when
initiating disciplinary actions action against a licensee or imposing sanctions
against a licensee who violates any of the provisions listed in Ph 1805.01
Source. #13463, eff 10-18-22
PART Ph 1806 RENEWAL OF LICENSES
Ph 1806.01 Renewal License Required. All advanced practice pharmacy technician
licenses shall expire biennially on March 31st in even numbered years.
Source. #13463, eff 10-18-22
Ph 1806.02 Renewal Application
Where Obtained and Filed.
Applications for the renewal of a license for an advanced practice
pharmacy technician may be obtained from, and shall be completed and filed with
OPLC, identified in Ph 103.03.
Source. #13463, eff 10-18-22
Ph 1806.03 Renewal Application Contents and When Filed. Renewal applications shall be filed with the
board in accordance with the
following:
(a)
Applicants for renewal of
a licensed advanced practice pharmacy technician shall complete and submit a
“Licensed Advanced Pharmacy Technician Renewal Form” PT-22 revised 7/2022;
(b) The competed application form and the $100
renewal fee shall be filed with the board no
later than March 31st;
(c)
Incomplete renewal applications shall not be renewed until the
application has been completed, the fee has been paid, and all documentation
required by the application has been submitted is submitted to show compliance
with all the renewal requirements set forth in Ph 1806; and
(d)
Renewal applicants whose licenses have lapsed shall not practice as an
advanced pharmacy technician until their licenses have been reinstated by the
board pursuant to RSA 318:26.
Source. #13463, eff 10-18-22
Ph 1806.04 Continuing Education Requirements for
Licensed Advanced Pharmacy Technician.
(a)
All licensed advanced pharmacy technicians shall maintain their national
certified status and stay up to date with all continuing education required by
such certification demands.
(b)
Licensed advanced pharmacy technicians with duties involving sterile and
non-sterile compounding shall complete a minimum of 0.4 CEU[’]s ACPE
approved, 0.2 CEU[’]s in each calendar year, in the area of compounding
or other competencies determined by the board.
(c)
Continuing education credits shall not be recognized for any repeat
program attended or completed. Repeat programs shall be identified as any
program didactic or correspondence which carries the same ACPET, CME or any
board of pharmacy program identification number.
(d)
The licensed advanced pharmacy technician shall retain all certificates
or other documented evidence of participation in an approved or accredited
continuing education program or course for a period of 4 years. Such documentation shall be made available to
the board for random audit or verification.
(e)
Not less than 10% of the registrants shall be randomly selected each
year by the board for determinations of compliance with Ph 1806.04.
Source. #13463, eff 10-18-22
Ph 1806.05 Excess CEUs. Excess CEUs earned in one licensure period
shall not be carried forward into the new licensure period for the purpose of
fulfilling that year’s continuing education prerequisite for licensure renewal.
Source. #13463, eff 10-18-22
PART Ph 1807 REINSTATEMENT OF A
SUSPENDED, REVOKED, VOLUNTARILY SURRENDERED, OR LAPSED LICENSE.
Ph 1807.01 Reinstatement. An advanced pharmacy technician whose license
to practice in this state has been suspended, revoked, voluntarily surrendered,
or allowed to lapse, and who wish to be reinstated shall:
(a)
File a reinstatement application with the board which shall include at
the following:
(1) Name, address, and telephone number of the
applicant;
(2) Date of birth; and
(3) Current employment information;
(b)
Pay the reinstatement fee of $200;
(c)
Submit certificates of attendance or participation in accredited with
approved continuing advanced pharmacy education courses or programs for a
minimum of 15 hours, of which at least 5 hours shall be earned in a live
setting. All such continuing education
shall have been earned in the period 24 months immediately preceding the date
of application for reinstatement;
(d)
If the advanced pharmacy technician has not held a license to practice
in this state for a period of 2 years or more, provide:
(1) A notarized affidavit(s) documenting the
advanced pharmacy technician experience during the 2 years immediately
preceding the date of their application for reinstatement;
(2) Proof of status of licensure in all states
that the advanced pharmacy technician has been or is currently licensed in; and
(3) Complete and pass with a minimum of 80% the
pharmacist in charge exam to assess the knowledge of the candidate regarding
their responsibilities as licensed advanced pharmacy technicians; and
(e)
If the advanced pharmacy technician has not held a license to practice
pharmacy in this state for a period of 5 years or more and has not practiced in
any other state, complete a practice internship no less than 160 hours in
duration prior to reinstatement.
Source. #13463, eff 10-18-22
PART Ph 1808 LICENSED ADVANCED PHARMACY TECHNICIANS –
STANDARDS OF PRACTICE
Ph 1808.01 Responsibilities. Persons
subject to these rules shall comply with the following:
(a)
Perform all functions under the supervision of a licensed pharmacist who
is physically on premises and holds an unrestricted license issued by the
board;
(b)
All licensed advanced pharmacy technicians shall wear a name tag,
identifying them as a “Licensed Advanced Pharmacy Technician”; and
(c) All licensed advanced pharmacy technicians
shall maintain national certification as a certified pharmacy technician.
Source. #13463, eff 10-18-22
Ph 1808.02 Licensed Advanced Pharmacy Technician’s Duties.
(a)
In addition to all the duties performed by a New Hampshire certified
pharmacy technician, licensed advanced pharmacy technician duties shall
include, but not limited to:
(1) Product verification; and
(2) Approval of drug preparation.
(b)
A licensed advanced pharmacy technician with duties involving sterile
and non-sterile compounding shall have completed a training program jointly
accredited by the American Society for Hospital Pharmacists and the
Accreditation Council for Pharmacy Education (ASHP/ACPE) before performing
those tasks.
(c) Licensed advanced pharmacy technician duties
shall not include:
(1) The
interpretation or evaluation of a prescription or drug order;
(2) Verification of
a compounded drug;
(3) Counseling or
advising individuals related to the clinical use of a medication;
(4) Duties that
require clinical knowledge, training, or judgement;
(5) Duties outside
their scope of training or education; and
(6) Any duty that a
federal or state law or regulation requires a pharmacist to perform.
Source. #13463, eff 10-18-22
PART
Ph 1809 ADVANCED PHARMACY TECHNICIAN
ADMINISTRATION OF VACCINES, QUALIFICATIONS, AND APPLICATION
Ph 1809.01 Qualifications.
(a) A New Hampshire licensed advanced pharmacy
technician who seeks to engage in the administration of vaccines shall meet the
requirements of RSA 318:16-b.
(b) An advanced pharmacy technician who seeks to
engage in the administration of vaccines shall hold current basic or higher
certification in cardiopulmonary resuscitation (CPR) from the American Heart
Association, the American Red Cross, or from another organization or entity
that is nationally-recognized as an issuer of such certifications.
(c) An advanced pharmacy technician shall not
delegate the administration of the influenza and COVID-19 vaccine to any
person.
Source. #13463, eff 10-18-22
Ph 1809.02 Application.
(a) An advanced pharmacy technician who seeks to
engage in the administration of influenza and COVID-19 vaccines, if available,
to the general public shall file a completed “Pharmacist and Advanced Pharmacy
Technician Application to Administer Vaccines” revised 7/2022.
(b) An application fee of $25.00 shall be
included with the application required by (a) above.
Source. #13463, eff 10-18-22
Ph 1809.03 Required Documents. The following documents shall be filed with
the application described in Ph 1808.02(a):
(a) Proof of possession of at least $1,000,000 of
professional liability insurance coverage; and
(b) Proof of having competed training specific to
administration of the respective vaccines that includes:
(1) Programs jointly approved
by the American Society for Hospital Pharmacist (ASHP) and the Accreditation
Council for Pharmacy Education (ACPE);
(2) Curriculum-based programs
from an ASHP/ACPE-accredited college of pharmacy;
(3) State or local health
department programs; or
(4) Programs recognized by the
board’s continuing education advisory council as required by Ph 403.12.
Source. #13463, eff 10-18-22
Ph 1809.04 Vaccine Administration Requirements. An advanced pharmacy technician who engages
in the administration of influenza and COVID-19 vaccines shall comply with the
following procedures:
(a) The advanced pharmacy technician shall be
under the supervision of an on-site immunizing pharmacist;
(b) Provide the patient with a Vaccine
Information Statement (VIS) as provided by the Centers for Disease Control
(CDC);
(c) Ensure that the patient has received and
signed the Patient Consent Form and has been counseled and their questions
answered prior to administration of the vaccine;
(d) Maintain and follow written policies and
procedures that establish a course of action:
(1) Adverse reactions;
(2) Anaphylactic reactions
including a standard order for treatment;
(3) Accidental needle sticks;
and
(4) Handling or disposal of
used or contaminated equipment and supplies;
(e) Report all adverse events to the Vaccine
Adverse Events Reporting System (VAERS) and to the primary care physician if
applicable;
(f) Provide the patient with documentation of the
vaccination and when appropriate report it to the immunization administration
section of the New Hampshire department of health and human services to be
added to the Vaccination Registry;
(g) Provide notice electronically, in writing or
by fax within 30 days to the primary care provider, when the practitioner has
been designated by the patient, of the administration of the pneumococcal and
varicella zoster vaccine and maintain documentation of the record for a minimum
of 4 years; and
(h) Be able to recognize anaphylaxis and maintain
at least 2 doses of injectable epinephrine at all times to treat a reaction if
it occurs.
Source. #13463, eff 10-18-22
Ph 1809.05 Recordkeeping. An advanced pharmacy technician who engages
in the administration of vaccines shall, for a minimum of 4 years, keep a
patient consent form that includes the:
(a) Name and date of birth of the patient;
(b) Name of the vaccine, manufacturer, lot
number, and expiration date of the vaccine;
(c) Description of the risks and possible side
effects of the vaccine;
(d) Date of administration;
(e) Supervising pharmacist’s name;
(f) Administering licensed pharmacy technician’s
name; and
(g) Signature of the patient.
Source. #13463, eff 10-18-22
PART
Ph 1900
– RESERVED
CHAPTER Ph 2000 LICENSING OF OUTSOURCING FACILITIES
IDENTIFIED AS 503B FACILTIES BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION
PART Ph 2001 PURPOSE AND SCOPE
Ph
2001.01 Purpose. The purpose of these provisions is to
regulate the licensing of outsourcing facilities, as defined and registered by
the Food and Drug Administration pursuant to section 503B of the Federal Food,
Drug and Cosmetic Act, codified as 21 USC 353b.
Source. #12336, eff 7-22-17
PART Ph 2002 DEFINITIONS
Ph
2002.01 Statutory Definitions Adopted. All terms used in these rules shall have the
same meaning as in RSA 318:1, RSA 318-B:1, and RSA 541-A:1.
Source. #12336, eff 7-22-17
Ph
2002.02 Other Definitions.
(a) “Outsourcing facility” means “outsourcing
facility” as defined in RSA 318:1, XXX, namely, “a facility at one geographic
location or address that is engaged in the compounding of sterile drugs, has
elected to register as an outsourcing facility, and complies with all of the
requirements of section 503B of the Federal Food, Drug, and Cosmetic Act.”
Source. #12336, eff 7-22-17
PART Ph 2003 STANDARDS OF PRACTICE FOR OUTSOURCING
FACILITIES
Ph
2003.01 Standards of Practice and
Requirements for Outsourcing Facilities.
(a) Outsourcing facilities shall maintain a human
drug compounding outsourcing facility registration from the United States Food
and Drug Administration (FDA) when compounding or manufacturing drugs for sale
in New Hampshire.
(b) Outsourcing facilities shall be in compliance
with applicable United States Drug Enforcement Administration (DEA)
regulations.
(c)
Outsourcing facilities shall be required to test all lots or batches of
finished drug products compounded from bulk active pharmaceutical ingredients
(API) to determine whether they meet final product specifications for
sterility, endotoxin, and potency before their release for distribution. No products shall be released for use until
this testing is conducted and the results confirm that the finished drug
product meets specifications. Copies of the test results shall be readily
available and included with each batch sent to New Hampshire customers and
available for inspection by the pharmacy board.
(d) Outsourcing facilities compounding drug
products from sterile, commercially available raw materials shall be required
to test all lots or batches of finished drug products to determine whether they
meet final product specifications for sterility, endotoxin, and potency before
their release for distribution. No
products shall be released for use until this testing is conducted and the
results confirm that the finished drug product meets specifications. Copies of the test results shall be readily
available for each batch sent to New Hampshire customers and available for
inspection.
(e) All facilities at which sterile drugs are
compounded shall provide storage areas that ensure adequate lighting,
ventilation, temperature, sanitation, humidity, equipment, and security
conditions. All sterile compounded
products shall be stored at appropriate temperatures per label requirements or
in compliance with the latest edition of the official United States
Pharmacopeia (USP) compendium requirements to help ensure that the identity,
strength, quality, and purity of the products are not affected. If no temperature requirements are listed,
compounded products may be stored at room temperature. A separate storage section shall be provided
for compounded products that are deteriorated, outdated, misbranded, or
otherwise adulterated.
(f) All buildings at which sterile drugs are
compounded shall be of a size, construction, and location that facilitates
cleaning and maintenance. The buildings
shall meet all applicable federal, state, and local standards. A facility shall not be located in a
residence. All facilities shall be
located in an area that is commercially zoned.
(g) Each outsourcing facility shall be equipped
with an internal alarm system to detect entry after hours. The alarm system shall be of the type that
transmits a signal directly to a central station protection company, to a local
or state police agency that has a legal duty to respond, or to a 24-hour
control station operated by the outsourcing facility.
(h) Outsourcing facilities shall ensure that all
access from outside their premises is secure.
This shall include, but not be limited to, the installation of adequate
lighting at the outside perimeter of the premises that deters unauthorized
entry into the premises.
(i) Internal security policies shall be developed
by the outsourcing facility to provide protection against theft by personnel.
(j) No outsourcing facility shall distribute
sterile compounded drugs directly to a consumer or a patient, or operate in
such a manner as to endanger the public health.
(k) Any person who compounds sterile drugs in
violation of RSA 318:51-d or the provisions of Ph 2000 shall be subject to
disciplinary action as provided in RSA 318:29.
Source. #12336, eff 7-22-17
Ph
2003.02 License Required.
(a) No person shall compound legend drugs or
controlled drugs, as defined in RSA 318-B:1, VI, and no person acting as or
employed by an outsourcing facility shall supply such drugs, without first
having obtained a license from the board.
No license shall be issued or renewed for an outsourcing facility unless
the same shall be operated in a manner prescribed by law and according to Ph
2000. The license shall expire
biennially on June 30 of each odd-numbered year. The license shall not be transferable.
(b) Separate licenses shall be required for each
compounding site owned or operated by an outsourcing facility. Provided, however, that an agent or employee
of any licensed outsourcing facility shall not be required to be licensed under
this section and may lawfully possess sterile compounded products if he or she
is acting in the usual course of his or her business or employment.
(c) Renewal applications shall be filed no later
than June 15th of every odd-numbered year and may be obtained from
the board office. Alternatively, renewal
applications may be filed online at https://nhlicenses.nh.gov/eGov/Login.aspx .
(d) The prescribed fee for original and biennial
renewal licenses for outsourcing facilities shall be $500.00.
Source. #12336, eff 7-22-17;
ss by #13117, eff 10-15-20
Ph
2003.03 Obtaining and Filing a
License Application.
(a) An “Application for Pemit – Bulk Sterile
& Non-Sterile Compounders (Including FDA Registered 503B Outsourcing
Facilities)”, form Ph OF-1, revised June 2017, for a permit to license FDA
registered 503B outsourcing facilities in New Hampshire may be obtained from
the board or board website;
(b) Form Ph OF-1 shall be used for:
(1) Applying for a permit to license a 503B
outsourcing facility;
(2) Changing the location of a currently licensed
503B outsourcing facility; and
(3) Changing the ownership of a currently
licensed 503B outsourcing facility.
(c) Form Ph OF-1 shall be filed at the board
office as identified in Ph 103.03.
Source. #12336, eff 7-22-17
Ph
2003.04 Application Contents.
(a) The applicant for a license to operate an
outsourcing facility in New Hampshire shall complete and file the form
described in Ph 2003.03.
(b) The applicant shall indicate his or her
title, and sign and date the application form under the following affirmation:
“I affirm that I am the person authorized
to sign this application for licensure and affirm that this application
(including any accompanying documents) has been examined by me and to the best
of my knowledge and belief is a true, correct and complete application, and if
the registration herein applied for is granted, I hereby agree to and do submit
to the jurisdiction of the New Hampshire Board of Pharmacy and to the laws and
rules of this State. I understand that
as an outsource facility I am required to comply with current Good
Manufacturing Practice (cGMP) standards.
I have read and understand the testing requirements required for
shipping compounded products into New Hampshire.”
(c) The applicant shall submit the following
documents with the application form:
(1)
If shipping controlled drugs, a copy of the facility’s current DEA
registration;
(2)
If licensed by the applicant’s home state, a copy of the current
license; and
(3)
If applicable, a copy of the most recent inspection report from the
applicant’s home state; and
(4)
If applicable, a copy of:
a.
The most recent FDA inspection report;
b.
The FDA issued Form 483; and
c.
The applicant’s response to the Form 483.
(d) The applicant shall submit scale drawings of
the facility, detailing usage of all space.
(e) The applicant shall supplement the
application with any certificates, affidavits, plans, documents, or other
information sufficient to show full compliance with all of the requirements for
licensure.
(f) If the applicant is a corporation, or if the
outsourcing facility will be operated under a corporate name, the applicant
shall submit a certificate from the secretary of state attesting to the
documents creating the corporate person and any amendment(s) thereof to the
certificate of incorporation, or authorizing it to do business in the State of
New Hampshire under the corporate name.
(g) The application shall be filed with the
prescribed fee of $500.00.
Source. #12336, eff 7-22-17; ss by #13117, eff
10-15-20
Ph
2003.05 Additional Requirements. In addition to the requirements imposed by Ph
2003.04, an applicant for an outsourcing facility license shall demonstrate
that he or she is of good moral character or, if the applicant is an
association or corporation, that the managing officers are of good moral
character, as evidenced by the absence, within the last 5 years, of conviction
of any felony, or of a misdemeanor resulting from a violation of any drug
related law of the United States or of any state.
Source. #12336, eff 7-22-17
Ph
2003.06 Issuance, Denial and
Revocation of License.
(a) If an applicant files an application,
complete in all respects and demonstrates fulfillment of all requirements of
these rules and RSA 318, the board shall issue a license which shall authorize
the operation of an outsourcing facility in the location, and only under the
name specified in the license.
(b) After consideration of the application, the
board shall notify the applicant in writing of all deficiencies in the
application which, in the absence of correction, shall result in the denial of
the application. The applicant shall, within 20 days of the date of the notice
of deficiency, deliver to the board either documents evidencing the correction
of those deficiencies, or a written request for an appeal before the board. In
the absence of a timely filing of either documentation or a request for an appeal,
the application shall, without further action or notice by the board, be denied
effective as of the expiration of 20 days after the date of the notification of
deficiency.
(c) The revocation of an outsourcing facility
license shall permanently withdraw the authority to supply compounded sterile
products in New Hampshire unless a subsequent license is issued pursuant to (d)
below.
(d) A subsequent license may be obtained only by:
(1) Complying with all the
requirements of RSA 318 and these rules regarding the original licensing of
outsourcing facilities;
(2) Paying all penalties
assessed in connection with the cause for revocation; and
(3) By demonstrating that
the cause for revocation does not exist at the time of the subsequent
application.
Source. #12336, eff 7-22-17
PART Ph 2004 NOTIFICATION REQUIREMENTS
Ph
2004.01 Reporting Changes. The person to whom a license to operate a
503B outsourcing facility has been issued in New Hampshire shall, within 30
days of that person's discovery of a change in any of the data contained in the
application for an original or renewal permit, report that change to the board
in writing. An original new permit application, “Application for Pemit – Bulk
Sterile & Non-Sterile Compounders (Including FDA Registered 503B
Outsourcing Facilities)”, form Ph OF-1, revised June 2017, shall be completed
and filed in addition to the written notice when the name, location, ownership,
or licensed area are changed.
Source. #12336, eff 7-22-17
Ph
2004.02 Notice of Disciplinary Action. An outsourcing facility licensed under these
rules shall, within 30 days of any written warnings or disciplinary action from
any state or federal licensing or enforcement agency, notify the board and
provide a copy of the action to the board office, identified in Ph 103.03.
Source. #12336, eff 7-22-17
PART Ph 2005 RENEWAL LICENSES
Ph
2005.01 Renewal Permits
Required. The person to whom a
license to operate a 503B outsourcing facility has been issued shall renew that
license by June 15th of every odd-numbered year.
Source. #12336, eff 7-22-17; ss by #13117, eff
10-15-20
Ph 2005.02 Renewal Application Where Obtained and
Filed.
(a) Applications for the renewal of a license to
operate a 503B outsourcing facility, “Renewal – Bulk Sterile & Non-Sterile
Compounders (Including FDA Registered 503B Outsourcing Facilities)”, form Ph
OF-2, revised June 2017, may be obtained from the board’s website at
www.oplc.nh.gov/pharmacy, and shall be filed at, the board office. Alternatively, renewal applications may be filed online at https://nhlicenses.nh.gov/eGov/Login.aspx
(b) The applicant shall indicate his or her
title, and sign and date the application form under the following affirmation:
“I affirm that I am the person authorized to sign this application
for licensure and affirm that this application (including any accompanying
documents) has been examined by me and to the best of my knowledge and belief
is a true, correct and complete application, and if the registration herein
applied for is granted, I hereby agree to and do submit to the jurisdiction of
the New Hampshire Board of Pharmacy and to the laws and rules of this State. I
understand that as an outsource facility I am required to comply with current
Good Manufacturing Practice (cGMP) standards.
I have read and understand the testing requirements required for
shipping compounded products into New Hampshire.”
(c) The applicant shall submit the following
documents with the application form:
(1) If shipping controlled
drugs, a copy of the facility’s current DEA registration;
(2) If licensed by the
applicant’s home state, a copy of the current license; and
(3) I f applicable, a copy of the most recent inspection report
from the applicant’s home state; and
(4) If applicable, a copy
of:
a. The most recent FDA
inspection report;
b. The FDA issued Form 483;
and
c. The applicant’s response
to the Form 483.
Source. #12336, eff 7-22-17; ss by #13117, eff
10-15-20
Ph
2005.03 Renewal Application Contents
and When Filed.
(a) Applications for renewal of a license to
operate a 503B outsourcing facility shall consist of a completed renewal
application form as described in Ph 2005.02 and the prescribed fee of $500.00.
(b) Renewal applications as required pursuant to
Ph 2005.01 shall be submitted to the board no later than the 15th
day of June of every odd-numbered year.
Source. #12336, eff 7-22-17; ss by #13117, eff
10-15-20
Ph
2005.04 Renewal Application
Deficiencies. The board shall notify
the applicant in writing as to whom the application for renewal is deficient.
The applicant may, within 10 days after the date of the notice of deficiency,
correct the deficiency or file with the board a written request for an appeal.
Source. #12336, eff 7-22-17
Ph
2005.05 Issuance and Denial of
Renewal License.
(a) If an applicant shall timely file an
application, complete in all respects, that demonstrates the fulfillment of all
the requirements of these rules and RSA 318, the board shall issue a renewal
permit.
(b) An application which continues to fail to
meet the requirements of these rules and RSA 318 shall, after the notice and
opportunity for a hearing, be denied.
Source. #12336, eff 7-22-17
PART Ph 2006 POLICIES, PROCEDURES AND RECORDKEEPING
Ph
2006.01 Written Policies and
Procedures.
(a) Written policies and procedures shall be
developed by management personnel to assure that the outsourcing facility
prepares for, protects against, and handles crises situations that affect the
security or operation of the facility. Such crises shall include fires, floods,
or other natural disasters, and situations of local, state or national
emergency.
(b) Written policies and procedures described in
(a) above shall also provide for:
(1)
The management and correction of all errors or inaccuracies in
inventories;
(2)
The assurance that any outdated stock, or any stock with an expiration
date that, in the outsourcing facility’s view, does not allow sufficient time
for repacking or resale, shall be prepared for return to the outsourcing
facility or otherwise destroyed; and
(3)
The control over the shipping and receiving of all stock within the
operation.
(c) A copy of the policies and procedures, or
sections thereof, shall be made available to the board upon request.
Source. #12336, eff 7-22-17
Ph
2006.02 Responsibility for Operation. An outsourcing facility shall maintain a list
of principals and persons in charge including officers, directors, or primary
stockholders and their qualifications.
Source. #12336, eff 7-22-17
Ph
2006.03 Returned Goods. An outsourcing facility shall maintain a
procedure for the handling and disposal of returned goods.
Source. #12336, eff 7-22-17
Ph
2006.04 Handling Recalls.
(a) An outsourcing facility shall maintain a
written policy for handling recalls and withdrawals for products.
(b) Policies required by (a) above shall cover
all recalls and withdrawals of compounded sterile products due to:
(1)
A voluntary action on the part of the compounder;
(2)
The direction of the Food and Drug Administration, or any other federal,
state or local governmental agency; and
(3)
Replacement of existing merchandise with an improved product or new
design.
Source. #12336, eff 7-22-17
Ph
2006.05 Recordkeeping.
(a)
The requirements of Ph 2006.05 shall be in addition to all record keeping and
reporting requirements contained in all federal regulations and state rules.
(b)
Inventories and other records of transactions regarding the receipt and
disposition of sterile compounded products shall be maintained and made
available for inspection by the board’s inspectors for a period of 2 years.
(c) Records may be kept at a central location
rather than at each outsourcing facility, but records shall be made available
for inspection within 72 hours of request by the board’s inspectors.
Source. #12336, eff 7-22-17
Ph
2006.06 Inspections.
(a) Outsourcing facilities shall be subject to
inspections by the FDA on a risk-based schedule.
(b) Information that is considered to contain
trade secrets or which might be proprietary in nature shall be protected from
public disclosure.
Source. #12336, eff 7-22-17
PART Ph 2007 DISPENSING AND DISTRIBUTION REQUIREMENTS
Ph
2007.01 Dispensing and Distribution
Requirements. Compounded sterile
drugs shall be dispensed in accordance with Ph 704.
Source. #12336, eff 7-22-17
PART Ph 2008 LEGAL REQUIREMENTS
Ph
2008.01 Compliance with State and
Federal Law.
(a) All outsourcing facilities licensed under
this chapter shall comply with all applicable state and federal laws, rules,
and regulations.
(b) All outsourcing facilities licensed and doing
business in New Hampshire, shall, before shipping or distributing any
compounded sterile drugs, verify that the recipient is properly licensed to
receive and possess such drugs.
(c) All outsourcing facilities licensed and doing
business in New Hampshire shall not provide unsolicited compounded sterile drug
samples to licensed practitioners.
(d) Except as provided in (c) above, a duly
authorized agent of an outsourcing facility licensed and doing business in New
Hampshire, may possess and distribute compounded sterile drugs to individuals
who may lawfully possess such drugs as may be necessary to further the licensed
activity of the outsourcing facility.
Source. #12336, eff 7-22-17
CHAPTER Ph 2100
INSPECTIONS
PART Ph 2101
AUTHORITY AND SCOPE
Ph
2101.01 Board Authority for
Inspections. All inspections shall
be conducted as stated in Ph 2104, as part of an investigation process, and at
the request of the various regulatory boards listed in RSA 318:8-a and RSA
318:9-a.
Source. #13028, eff 4-11-20
Ph
2101.02 Scope. Registrants and licensees, including all
pharmacists, pharmacies, and practitioners pursuant to RSA 318:8-a and RSA
318:9-a, shall permit the board investigators, board inspectors, and board
commissioners to enter and inspect the premises and audit the records and
operations for compliance with the statutes and rules enforced by or under the
board’s jurisdiction.
Source. #13028, eff 4-11-20
PART Ph 2102 DEFINITIONS
Ph 2102.01
Definitions. In addition to the definitions in RSA 318:1,
the following definitions shall apply to this chapter:
(a)
“Clinics” means an institution, building, or part of a building
devoted to the diagnosis and care of outpatient ambulatory patients. The term
also includes public health
clinics and methadone clinics;
(b) “Compounding pharmacy” means a pharmacy
licensed to perform the preparation, mixing, assembling, packaging or labeling of a drug
or device as a result of a practitioner's prescription drug order;
(c) “Facility” means any pharmacy, hospital,
medical clinic, practitioner office, methadone clinic, or veterinarian
clinic that has prescription drugs on its premises and is inspected by the
pharmacy board;
(d) “High risk compounding” means compounding that
requires the use of non-sterile ingredients or non-sterile devices, which
usually creates a high-risk condition. Exposing sterile ingredients and devices
to air quality below ISO Class 5, an International Organization for
Standardization metric for environmental management, will create a high-risk
compounding situation, as will the prolonged storage of opened or
partially-used products that lack antimicrobial preservatives in an environment
in less than ISO Class 5 conditions;
(e) “In-patient institution” means a facility where a patient is formally admitted or hospitalized for
treatment or care and stays for a minimum of one night in the hospital or other
institution providing in-patient care;
(f) “Inspector” means a pharmacist or certified
pharmacy technician employed by the pharmacy board to inspect
facilities, to ensure that they comply with federal and state law and the rules
established by the board;
(g) “Institution” means an “institution” as
defined in Ph 701.02(h), namely a health care facility which provides inpatient
care and includes:
(1) Hospitals;
(2) Nursing
homes;
(3) Extended
care facilities;
(4) Residential
care facilities;
(5) Infirmaries;
and
(6) Correctional
facilities.
(h) “Institutional pharmacy” means an “institutional
pharmacy” as defined in Ph 701.02(i), namely “an area in an
institution where drugs are stored, manufactured, compounded, dispensed, or
issued to other areas or departments of the institution;”
(i) “Investigator” means a pharmacist employed by
the pharmacy board to investigate consumer complaints of pharmacy law or rule
violations by a person licensed at the time the alleged violation occurred;
(j)
“Licensee” means any person or entity which is licensed, certified,
registered, or regulated by the pharmacy board or a board listed in RSA 318:8-a
and RSA 318:9-a;
(k) “Limited retail drug distributor” means a distributor of
prescription devices or medical gases delivered directly to the consumer
pursuant to a practitioner's prescription order, or federally funded clinics
operated under contract with the department of health and human services and
drug abuse treatment centers, where legend and controlled drugs are held,
stored, or dispensed to patients pursuant to the order of an authorized
practitioner;
(l)
"Limited retail drug distributor'' means a distributor of legend
devices or medical gases delivered directly to the consumer pursuant to a
practitioner's prescription order, or federally funded clinics operated under
contract with the department of health and human services and drug abuse
treatment centers, where legend and controlled drugs are held, stored, or
dispensed to patients pursuant to the order of an authorized practitioner;
(m)
“Methadone clinic” is a clinic which has been established for the
dispensing of methadone and other medications to treat opioid addiction. In the
United States, by law, patients must receive methadone under the supervision of
a physician, and dispensed through an opioid treatment program certified by
Substance Abuse and Mental Health Services Administration and registered with
the Drug Enforcement Agency;
(n) “Practitioner” means any person who is
lawfully entitled to prescribe, administer, dispense or distribute prescription
drugs to patients;
(o) ”Public health clinics”, are
private, nonprofit organizations that directly or indirectly, through contracts
and cooperative agreements, provide primary health services and related
services to residents of a defined geographic area that is medically underserved. The term includes “community health centers
(CHCs); and
(p) “Retail pharmacy” means a pharmacy that
dispenses and sells prescription drugs to patients with a valid prescription in
an outpatient setting at retail prices.
Source. #13028, eff 4-11-20
PART Ph 2103 PRE-INSPECTION REQUIREMENTS
Ph 2103.01 Licensee Pre-Inspection Duties for
Pharmacies.
(a) All pharmacies shall be mailed, one to 3
months prior to inspection, a “Pre-Inspection Checklist” advising the
pharmacist-in-charge or designated representative that the items listed in (b)
below must be readily available to pharmacy board inspectors at the beginning
of the inspection.
(b)
The following items must be available to board inspectors at the
beginning of the inspection:
(1) A printed list of the
facility’s hours of operation;
(2) The average daily and weekly volume of prescriptions processed;
(3) The e-mail address of the pharmacist in charge or designated
representative;
(4) A list of all pharmacists
employed at the pharmacy, with license number, if applicable;
(5) A list of all certified
pharmacy technicians employed at the pharmacy with registration number, if
applicable;
(6) A list of all registered pharmacy technicians
employed at the pharmacy with registration number, if applicable;
(7) A list of current pharmacy technician training data for technicians in
certification training program, if applicable;
(8) Date of most recent alarm
test;
(9) Policy for dispensing Narcan/naloxone
(10) Copy of pharmacy’s break
policy, if applicable;
(11) Break counseling log book, if applicable;
(12) Drug
recall file;
(13) Documentation
of patient counseling, if applicable;
(14) Protocol
for vaccines;
(15) Evidence
of up to date pharmacist CPR certification, if applicable;
(16) Pharmacist
vaccination training information, if applicable;
(17) Collaborative
practice agreements, if applicable; and
(18) Quality assurance
information as stated in Ph 1700, if applicable;
(c) Pharmacies involved in sterile and non-sterile
compounding shall have available for pharmacy board review a copy of their
scheduled outsourced environmental monitoring report as required by Ph 405.05
relative to sterile quality requirements.
(d) Pharmacies shall make available all
environmental monitoring reports upon request.
Source. #13028, eff 4-11-20
PART Ph 2104 INSPECTION
FREQUENCY
Ph 2104.01 Scheduling. Inspections shall be:
(a) For any facility involved in sterile
compounding, scheduled up to one month in advance;
(b) Unannounced for any other facility,
notwithstanding the pre-inspection checklists sent to licensees in the quarter
in which their inspection shall take place;
(c) Conducted upon the presentation of appropriate
identification; and
(d)
Investigators/inspectors shall present a “Notice of Inspection” form
(#Ph510) upon arrival detailing the purpose of the inspection to the person of
record on the day of the inspection. The
form shall be signed underneath the following certification statement:
This is to acknowledge that NH Board of Pharmacy
Inspector/Investigator, ____________ has identified him/her self by
presentation of official credentials pursuant to the provisions of NH RSA
318:8, RSA 318:8-a of the NH Pharmacy Act and RSA 318-B:25 of the NH Controlled
Drug Act, and I hereby grant permission for the aforementioned Board agent to
inspect any and all of the records relative to the receipt, distribution and
security of prescription/legend drugs at this location. This also includes
records which are required per the provisions of 21 CFR 1300 to end, of the
Federal Controlled Substances Act. This inspection also addresses any other
standards of practice issues outlined by other health care agencies, which
these agents are charged to enforce. By my signature below, I hereby
acknowledge the receipt of this Notice of Inspection and certify that:
1. I am the (title)
_____________________________________, for the above described location;
2. I have read this Notice of Inspection and
understand its contents and purpose;
3. I have the authority to act in this matter and
have signed this Notice of Inspection pursuant to my authority;
4. I have been provided with the purpose of this
Notice of Inspection as noted above, but fully realize that thescope
of this inspection may encompass ALL of the records required pursuant to the
above mentioned State/Federal Statutes and Rules/Regulations; and
5. I have voluntarily consented to this
inspection.
Source. #13028, eff 4-11-20
Ph 2104.02 Inspection Timeframes.
(a) Unless otherwise specified in this chapter,
pharmacy board inspections shall be conducted at a minimum:
(1) Annually for:
a. Retail
pharmacies;
b. Institutional
pharmacies;
c. Compounding pharmacies;
d. Public
health clinics; and
e. Methadone
clinics.;
(2) Every 3 years for:
a. Veterinarians
and veterinary clinics without controlled substances;
b. Drug
manufacturers;
c. Drug
wholesalers;
d. Limited
retail drug distributors; and
e. Naturopaths
without controlled substances.
(3) Every 5 years for:
a. Practitioners
in private practice without controlled substances; and
b. Medical
and hospital clinic-based practitioner without controlled substances.
(b) The following entities possessing controlled
substances shall be inspected at a minimum every 2 years;
(1) Practitioners in private practice;
(2) Clinic-based practitioners;
(3) Veterinarians or veterinary
clinics; and
(4) Naturopaths.
Source. #13028, eff 4-11-20
PART Ph 2105 RISK LEVEL
INSPECTIONS
Ph 2105.01 Risk Level Assignment.
(a)
Pharmacy inspections shall be conducted based on risk level as assigned
by pharmacy board staff.
(b) Risk level shall be assigned by the pharmacy
board compliance staff following inspection and shall be reevaluated on a
yearly basis or upon:
(1) A review of
previous inspections;
(2) A review of
minor violations if applicable;
(3) A review of
control loss information;
(4) A major
violation as set forward in this chapter; or
(5) Investigatory
discipline as set forward in Ph 2200.
(c) A pharmacy’s prescription volume level shall
be evaluated by the pharmacy board compliance staff and assigned as:
(1) Low, for a
prescription volume of less than 1,250 prescriptions per week;
(2) Medium, for
a prescription volume of 1,250 or more and less than 2,000 prescriptions per
week; and
(3) High, for a
prescription volume of 2,000 or more prescriptions per week.
(d) Risk level assignments and inspections, in
addition to the self-inspection requirements in Ph 2106, shall be as follows:
(1) For low risk inspections:
a. Pharmacy
board inspections shall occur biennially; and
b. Low
risk facilities shall include:
1. Retail pharmacies with a proven record of
compliance for a period of 3 years;
2. Facilities with a low to medium prescription
volume; and
3. Facilities with a pharmacist-in-charge with no
violations in the previous 2 years and previous satisfactory inspection and
stability of at least 2 years at the site;
(2) For medium risk inspections:
a. Board
inspections shall occur annually; and
b. Medium
risk facilities shall include:
1. Institution pharmacies not involved in sterile
or non-sterile compounding;
2. In-patient institutions involved in sterile or
non-sterile compounding as defined by United States Pharmacopeia Chapter 797
(USP 797);
3. High prescription volume pharmacies with a
pharmacist-in-charge stability of at least 2 years at site as identified by
pharmacy board staff;
4. Pharmacies with 6 minor violations or
warnings, such as for temperature variations of refrigerated storage;
5. Non-sterile compounding pharmacies; and
6. Outpatient pharmacies involved in low to
medium risk compounding as defined by USP 797; and
(3) For high risk inspections:
a. Pharmacy
board inspections shall occur up to 2 times a year; and
b. High
risk facilities shall include:
1. Outpatient pharmacies involved in high risk
sterile and complex nonsterile compounding as defined by USP 797;
2. Retail pharmacies with any previous violation
of federal law, including previous cases of drug diversion, or a record of
non-compliance with state law or administrative rule by pharmacy staff or
permit holders over a 3-year period;
3. Pharmacies with a pharmacist-in-charge change
3 or more times in one calendar year;
4. Pharmacies with any unresolved control drug
loss forms pursuant to Ph 700; and
5. Practitioners,
clinics, veterinarians, veterinary clinics, naturopaths, and non-institutional
pharmacies involved in non-sterile and compounding.
Source. #13028, eff 4-11-20
PART Ph 2106 SELF-INSPECTIONS
Ph 2106.01 Self-Inspection Requirements.
(a) A self-inspection shall be conducted in
accordance with, and documented upon, the self-inspection survey provided by
the pharmacy board.
(b) Upon a required self-inspection, the pharmacy
board shall email to each licensee either:
(1) A “Retail
Self-Inspection Survey,# ph538” revised 11/1/2018, or
(2) An
“Institutional Self-Inspection Survey, #ph 557” revised 11/1/2018.
(c) Licensees shall complete all self-inspection
surveys within 7 days of receipt.
(d) A self-inspection shall include environmental
monitoring reports, if applicable under Ph 404, for board review.
(e) The original self-inspection form
shall be printed, signed, dated, and kept on file in a readily available format
upon pharmacy board inspection for 4 years.
Source. #13028, eff 4-11-20
Ph 2106.02 Required Self-Inspections by Risk Level.
(a) A low risk facility shall conduct a
self-inspection each year in which it is not inspected by the pharmacy board.
(b) A medium risk facility shall conduct a
self-inspection upon request by the pharmacy board.
(c)
The pharmacy board shall request a self-inspection under (b) above upon
receipt of a complaint involving the facility, upon receipt of a controlled
drug loss form, or as a follow-up self-inspection after a regular board
inspection.
Source. #13028, eff 4-11-20
Ph 2106.03 Self-Inspection for Change of the
Pharmacist-in-Charge.
(a) A self-inspection shall be required
within 7 days of a pharmacy board-approved change in a
pharmacist-in-charge.
Source. #13028, eff 4-11-20
(b) A copy of the “change in pharmacist-in-charge”
application, outlined in Ph 700, shall be on file and readily retrievable upon
pharmacy board inspection or on request of the pharmacy board.
Source. #13028, eff 4-11-20
PART Ph 2107 INSPECTION PROCESS
FOR PRACTITIONERS
Ph 2107.01 Inspection Practices. The pharmacy board shall develop inspection
practices related to the practice of pharmacy for the following regulatory
boards as stated in RSA 318:8-a and RSA 318:9-a:
(a)
Board of medicine;
(b)
Board of nursing;
(c)
Board of dental examiners;
(d)
Board of veterinary medicine;
(e)
Board of podiatry;
(f)
Board of registration in optometry; and
(g) Naturopathic
board of examiners.
Source. #13028, eff 4-11-20
Ph 2107.02 Performance of Inspections.
(a) Inspections
shall
be performed, after presentation of proper identification, by pharmacy
board investigators, inspectors, or commissioners, and he or she shall have
access to all records concerning the purchase, storage, labeling, distribution,
compounding, reconstitution, and disposal of prescription drugs.
(b) Inspections
for licensees of the boards included in RSA 318:8-a and RSA 318:9-a, shall
include:
(1) Verification
of active DEA number and prescription monitoring program registration and all
delegates;
(2) General
facility and security related to the practice of pharmacy;
(3) Proper
storage of medications;
(4) Proper
labeling of medications;
(5) Complete
record keeping of distribution of control drug medications;
(6) Proper
disposal of medications; and
(7) Purchasing
information of medications.
(c)
Inspections for licensees involved with non-hazardous sterile and
non-sterile compounding of medications as stated in 318:14-a shall include:
(1) Verification
of patient specific medications;
(2) Purchasing
information from pharmacy board-licensed wholesaler/manufacturer;
(3) Training of
personnel in aseptic technique and available for review;
(4) Standards
of practice policy and procedure for injectable or intravenous medications; and
(5) Policy and
procedure to ensure environment meets minimum requirements related to the practice of pharmacy.
(d) Inspections for licensees involved with
hazardous sterile compounding of medications as stated in 318:14-a shall
include:
(1) Demonstrated
adherence with Ph 404 standards concerning sterile compounding;
(2) Be licensed with the pharmacy board as an institutional pharmacy/infusion center;
(3) Policies
and procedures for hazardous spills related to the practice of pharmacy; and
(4) The spill
kit in the facility.
Source. #13028, eff 4-11-20
2107.03 Inspection Frequency for Practitioners. Practitioner inspections shall occur based on
a risk assessment level assigned by pharmacy board compliance staff based on
the factors in Ph 2107.04 through 2107.06.
Source. #13028, eff 4-11-20
Ph 2107.04 Category I: High Risk. The following providers’ offices that
dispense or administer prescription medications shall be inspected biennially:
(a)
Veterinarians in private practice offering intravenous services for
non-sterile and sterile compounding of medications;
(b)
Animal hospitals/clinics;
(c)
Oral surgeons;
(d)
Ambulatory surgical units (ASUs);
(e)
Provider offices offering intravenous services for sterile compounding;
and
(f)
Naturopath providers offering intravenous services.
Source. #13028, eff 4-11-20
Ph 2107.05 Category II: Medium Risk. For the following providers without
controlled substances who dispense or administer prescription medications,
inspections shall be every 3 years:
(a)
Private practice providers without a hospital/HMO affiliation, also
known as independent private practice providers; and
(b)
Veterinarians in private practice.
Source. #13028, eff 4-11-20
Ph 2107.06 Category III: Low Risk.
For the following providers without
controlled substances who dispense or administer prescription medications,
inspections shall be upon request of the provider’s board or provider:
(a)
Private practice physicians with a hospital/HMO affiliation;
(b)
Providers who are always affiliated with a hospital/HMO;
(c)
Naturopath providers with no prescription legend medications; and
(d)
Other health care providers with no prescription legend medications.
Source. #13028, eff 4-11-20
PART Ph 2108 INSPECTION REPORTS
Ph 2108.01 Inspections.
(a) Inspections for pharmacy licensees, and
licensees of the boards included in RSA 318:9-a and 318:8-a, shall include the
certification listed in (d) and inspectors shall use the following forms:
(1) For retail
pharmacies, all matter included in the “Retail Pharmacy-Inspection Form, #ph
511” revised 11/1/2018, available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(2) For
institutional pharmacies, all matter included in the “Institutional
Pharmacy-Inspection Form, #ph 519” revised 11/1/2018, available on the pharmacy
board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm;
(3) For long
term care pharmacies, all matter included in the “Long Term Care
Pharmacy-Inspection Form, #ph 516” revised 11/1/2018, available on the pharmacy
board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm;
(4) For
methadone clinics, all matter included in the “Methadone Clinic-Inspection
Form, #ph 517” revised 11/1/2018, available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(5) For manufacturers and wholesalers, all matter
included in the “Manufacturer/Wholesaler-Inspection Form, #ph 518” revised
11/1/2018, available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(6) For practitioners and clinics, all matter included
in the “Practitioner/Clinic-Inspection Form, #ph 554” revised 11/1/2018,
available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(7) For public
health clinics, all matter included in the “Public Health Clinic-Inspection
Form, #ph 520” revised 11/1/2018, available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(8) For naturopathic practitioners and clinics, all
matter included in the “Naturopathic Practitioner/Clinic Inspection Form, #ph
560” revised 11/1/2018, available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(9) For
facilities which maintain controlled substances, all matter included in the
“Controlled Substance-Inspection Form, #ph 512” revised 11/1/2018 available on
the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm;
(10) For home
infusion and sterile compounding facilities, all matter included in the “Home
Infusion/Sterile Compounder-Inspection Form, #ph 513” revised 11/1/2018,
available on the pharmacy board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm;
(11) For
prescription device and medical gas distributors, all matter included in the
“Inspection Form Prescription Device/Medical Gas Distributors, form # ph 515,” revised
11/1/2018, available on the pharmacy board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm;
(12) For break
policies involving pharmacists, all matter included in the “Pharmacist Break
Policy Supplemental Inspection Form ph 553,” revised
11/1/2018, available on the pharmacy board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm. and;
(13) For
practitioners offices, all matter included in the “Facilities performing IV
infusion according to Manufacturer Labeling or Aseptic Technique Form # ph 559” revised 11/1/2018, available on the pharmacy
board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm.
(14) For
compounding and dispensing parenterals in an
institutional setting USP 795/797 inspection form Ph 514 revised 11/1/18,
available on the board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm.
(15) For
compounding and dispensing non-sterile preparations, compounding audit
inspection form Ph 563 revised 11/1/19, available on the board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm.
(16) For
compounding and dispensing sterile preparations, compounding audit inspection
form Ph 564, revised 11/1/19, available on the board’s website at https://www.oplc.nh.gov/pharmacy/compliance.htm.
(b) Upon inspection, all prescription and
medication files requested by the investigator or inspector shall be available on demand.
(c) If, during the course of an inspection, the
inspector identifies a violation of an administrative rule, the inspector shall
issue a minor or major violation notice to the licensee as stated in Ph 2200
and Ph 2109.
(d)
The inspection forms listed in (a) above shall require a
representative’s signature on the following certification:
My signature
acknowledges my awareness and understanding of all entries and notations made
on this report and my receipt of a copy
thereof. I also understand my
responsibilities for corrective action as outlined above.
Source. #13028, eff 4-11-20
Ph 2108.02 Inspection Report Requirements.
(a) Inspectors or investigators shall have all
inspection reports, that is, forms as described in Ph 2108.01, reviewed and
signed by the pharmacist on duty or designated representative at the completion
of an inspection.
(b) A copy of the inspection report shall be
provided to the licensee or registrant and shall be made available, in a
readily retrievable manner, on request of the pharmacy board.
(c) Inspection report results shall be:
(1) Satisfactory,
indicating no issues or violations;
(2)
Unsatisfactory, indicating the finding of a violation; and
(3) Not
applicable.
(d) If an “unsatisfactory” result on a pharmacy
inspection occurs, the pharmacist-in-charge shall be required to do the
following:
(1) Immediately
fix the issues noted by the investigator or inspector and respond in writing to
the pharmacy board within 10 days with a detailed report on the actions taken;
(2) If an
immediate fix is not possible, then a detailed action plan shall be developed
with a timeline that shall be approved by the investigator or inspector; or
(3) Schedule an
immediate follow up inspection, if applicable.
(e)
If an “unsatisfactory” result on a provider inspection occurs, the
report shall be forwarded to the respective board for review.
(e) T he current compliance inspection
report of the licensed location, conducted by the board, shall be kept on file
in the facility per Ph 703.06.
(f) Inspection reports shall be stored by the
pharmacy board in a licensing data base by name of the permit holder and the
pharmacist-in-charge.
Source. #13028, eff 4-11-20
PART Ph 2109 VIOLATION AND
VIOLATION NOTICES
Ph 2109.01 Violation Notices.
(a) The board inspector shall issue a violation
notice to a licensee should the inspector find, during the
course of an inspection, noncompliance with an administrative rule or federal,
state, or local law related to the practice of pharmacy. A licensee or
practitioner may contest any notice of violation as provided in Ph 2207.02.
(b) All violation notices shall be forwarded to
the respective regulatory board of the licensee for review and appropriate
action.
(c) Violations of rules under RSA 318-B shall
result in a fine by the pharmacy board.
(d) Violation notices that are not appealed, or
that are determined to be founded after appeal, shall be kept on file in an
appropriate licensing data base of the pharmacist-in-charge and permit holder.
All violation notices shall be readily retrievable upon inspection,
investigation, or request of the pharmacy board for a period of 2 years.
Source. #13028, eff 4-11-20
Ph 2109.02 Minor Violations.
(a) The minor violations shall be as listed in Ph
2109.07.
(b) Remedying any minor violations shall be the
responsibility of the pharmacist-in-charge and the permit holder. All
corrective action taken shall be documented and mailed to the pharmacy board
office with 15 days of notification.
(c)
The investigator/inspector shall review remediation and respond if not
satisfactory.
(d)
All minor violation notices shall be made available to the pharmacy
board at next scheduled meeting.
(e) Repeat minor violations shall result in board
review with a consideration for further disciplinary action under RSA 318:29.
Source. #13028, eff 4-11-20
Ph 2109.03 Major Violations.
(a) Major violations shall as listed in Ph
2109.08.
(b) All major violations for those regulated by
the board of pharmacy shall be the responsibility of the pharmacist-in-charge
and the permit holder. The pharmacist-in-charge and the pharmacist on duty at
the time of violation shall be responsible for correcting the violation. This
corrected action shall be recorded on the violation notice
and returned to the inspector or investigator within 15 days of receiving the
notification.
(c) Major violations shall be reviewed by the
pharmacy board at the next scheduled meeting for possible further
disciplinary action.
(d)
Major violations for practitioners shall be referred to the respective
regulatory board for review.
Source. #13028, eff 4-11-20
Ph 2109.04 Drug Monitoring Program Violation
Notifications.
(a) Any person or entity who fails to submit the
information required in RSA 318-B:33, or knowingly submits incorrect
information, shall be subject to a warning letter and provided with an
opportunity to correct the failure.
(b) Any person or entity who subsequently fails to
correct such failure, or who fails to resubmit the information, shall be
subject to discipline by the board in reference to RSA 318-B:36.
Source. #13028, eff 4-11-20
Ph 2109.05 Administrative Fines. Violations found in the course of an
inspection shall be subject to administrative fines pursuant to Ph 2207.02.
Source. #13028, eff 4-11-20
Ph 2109.06 Prescription Monitoring Program Audit.
(a)
Pharmacy board investigators/inspectors shall audit prescriptions at the
request of the PMP auditor during normal inspection;
(1) Auditor shall request from
pharmacy/provider 8 prescriptions from random sampling a minimum of 2 weeks
prior to inspection;
(2) Pharmacy board
investigators/inspectors shall verify data per audit procedure and return
copied information to auditor; and
(3) Pharmacy board
investigators/inspectors shall select 2 additional prescriptions for audit per
audit procedure.
(b)
Failure to provide or correct data per RSA 318-B:36, I shall be subject
to pharmacy board review and possible disciplinary action under RSA 318:29.
Source. #13028, eff 4-11-20
Ph 2109.07 Minor Violation Schedule. The following violations shall be considered
minor violations for which licensees shall be subject to a $25.00 fine:
(a)
General Violations:
(1) Pharmacist
license is not posted;
(2) Pharmacy
has insufficient equipment;
(3) The work
area is not orderly and clear of obstructions;
(4) Equipment
inspection/calibration issues;
(5) Pharmacy
permit not posted;
(6) Improper
security;
(7) Out of date
or mislabeled drug;
(8) Improper
drug storage;
(9) Improper
drug destruction;
(10) Improper
supervision of support personnel;
(11) Improper
registration procedures;
(12) Nametags;
(13) Improper
documentation of training;
(14) Improper
return to stock procedures;
(15) Improper
dispensing/labeling;
(16) No drug
regimen review;
(17) No P&P
manual;
(18) Food in Rx
refrigerator;
(19) Shelving
not clean and orderly;
(20) Outdated
drugs separate from active inventory;
(21) Quality
Assurance Info Unavailable;
(22) Quality
Assurance Meeting Held Quarterly;
(23) Purified
Water System Inadequate;
(24) No hot/cold running water;
(25) No CMEA
certificate;
(b)
Retail Violations:
(1)
Prescription lacks proper information;
(2) Counseling
area inadequate
(3) No
counseling by RPh;
(4) Do not fill
date followed;
(5) Allergies
not properly noted;
(6) No CPR
certification for vaccines;
(7) No vaccine
provider information;
(8) Vaccination
standing order;
(9) No lunch
break;
(10) No lunch
break signage;
(11) Improper automated dispensing
procedures;
(12) Improper
telephone/voicemail order intake;
(13) Patient care guidelines
incomplete;
(c)
Hospital violations:
(1) Area for
non-sterile compounding inadequate;
(2) Records for
non-sterile compounding
(3) Master
compounding formulary;
(4) Improper
procedures for IV preparation;
(5) Area for
preparation of sterile products;
(6) Improper
packaging procedures;
(7)
Cytotoxic/biohazardous procedures;
(8) Open
multi-dose vials expiration dates;
(d)
Controlled Substances:
(1) Controlled
substance vendor return confirmation;
(2) CII locked
or dispersed;
(3) No power of
attorney;
(4) Dispensing
record not available;
(5) Improper
transfer of prescription controlled substances;
(6) Controlled
substance prescription pharmacist sign/date;
(7)
Prescription 222 form records not in numerical order;
(8)
Non-compliant NH controlled drug loss/DEA 106 forms;
(9) Controlled
substances invoices not separated;
(10) No CII
monthly perpetual inventory;
(11) No
daily/nightly controlled substances log;
(12) Controlled
substances returns procedure inadequate;
(e)
PDMP:
(1) Failure to verify
prescriptions with the PDMP; and
(2) PDMP provider
verification.
Source. #13028, eff 4-11-20
Ph 2109.08 Major Violation Schedule. The following shall be considered major
violations:
(a) F or which licensees be subject to a $100.00
fine:
(1) The failure
of equipment such as the medication/vaccine refrigerator or freezer, hot or
cold water, heat of air conditioning failure causing the pharmacy to be outside
the appropriate temperature range for proper drug storage per the manufacturer;
(2) Failure to
Maintain Temperature Logs;
(3) No Signage
on Hardcopy of C/S Rx;
(4) Printed C/S
Rx Not Marked Copy Only- Not Valid for Dispensing
(5) Immunizing Pharmacist or Immunizing Intern with
Expired CPR Certification or Liability Insurance Policy;
(6) CII
Inventory Missing or Incomplete;
(7) Failure to
Report Changes of Name, Address, or Work Location within 15 Days; and
(8) Pharmacist technician or intern working in the
pharmacy while unregistered or with an expired registration.
(b)
For which licensees shall be subject to a $250.00 fine:
(1) DEA 222
forms were not sent to the DEA; and
(2) A
registered pharmacy technician has been performing certified pharmacy
technician duties.
(c)
For which the licensee shall be subject to a $500.00 fine:
(1) The
biennial inventory is missing or not done;
(2) A failure
to report a controlled substance loss;
(3) A
pharmacist has been working in the pharmacy while unlicensed or with an expired
license;
(4) The
pharmacy is an unfit place to work;
(5) The
pharmacy failed to report a change of its pharmacist-in-charge in a timely
manner;
(6) No
pharmacist-in-charge change inventory was done;
(7) The
pharmacy has been operating without a pharmacist-in-charge; and
(8) Issues with
pharmacy access or security.
(d)
The licensee shall be subject to a $1,000.00 fine if the pharmacy is not
registered with the PDMP.
(e)
The licensee shall be subject to a $5,000.00 fine if the licensee has
failed to respond to a violation notice or report of investigation.
Source. #13028, eff 4-11-20
CHAPTER Ph 2200 PHARMACY
BOARD INVESTIGATIONS
PART Ph 2201 DEFINITIONS
Ph 2201.01 Definitions. In addition to RSA 318:1, the following
definitions shall apply to this chapter:
(a)
“Board investigator” means a pharmacist
employed by the pharmacy board to investigate violations of the pharmacy laws
or the rules of the pharmacy board by a person licensed at the time the alleged
violation occurred;
(b)
“Confidential letter of concern” means a warning letter issued by the
pharmacy board to a licensee as a type of outcome to an investigation conducted
by the pharmacy board investigators;
(c) “Drug diversion” means the illegal
distribution of prescription controlled drugs, or transfer of any legally prescribed controlled substance from the individual for whom it
was prescribed to another person for any illicit use;
(d)
“Facility” means any pharmacy,
hospital, clinic, practitioner offices, methadone clinic, orveterinarian
clinic that have medication on their premises and are inspected by the pharmacy
board;
(e)
“Infusion center” means a place, usually outpatient, where patients can
receive intravenous infusions and therapeutic injections in a safe,
professional, and comfortable environment;
(f)
“Licensee” means any entity or individual which is licensed, certified,
registered, or regulated by the pharmacy board or a board whose licensees are
subject to investigation under RSA 318:30;
(g)
“Medication error” means any
preventable event that may cause or lead to inappropriate medication use or
patient harm, while the medication is in the control of the healthcare
professional or patient. Such events can be related to professional practice,
healthcare products, procedures, and systems including prescribing, order
communication, product labeling, packaging and nomenclature, compounding,
dispensing, distribution, administration,
education, monitoring, and use.
(h)
“Methadone clinic” means a clinic which has been established for the dispensing of methadone, a schedule II drug under the
Controlled Substance Act, for the purpose of treating addiction disorder;
(i)
“Naturopathic medicine” means “naturopathic medicine” as defined in RSA
328-E:2, IX, namely, “a system of primary health care practiced by doctors of
naturopathic medicine for the prevention, diagnosis, and treatment of human
health conditions, injuries, and disease that uses education, natural
medicines, and therapies to support and stimulate the individual’s intrinsic
self-healing processes;”
(j)
“Nurse practitioner” means a
registered nurse currently licensed by the board under RSA 326-B:18. The term includes “advanced practice
registered nurse (APRN).;
(k)
“Professional misconduct” means behavior by a
professional that implies an intentional compromise of ethical standards,
including the acts specified in RSA 318:29, II;
(l)
“Quality related event (QRE)” means the
incorrect dispensing of a prescribed medication that is received by a
patient, including a variation from the prescriber’s prescription order, or
failure to identify and manage errors identified during a drug utilization
review; and
(m) “Tele-pharmacy service” means the delivery of pharmaceutical care via telecommunications to patients in
locations where they may not have direct contact with a pharmacist.
Source. #12997, eff 3-5-20
PART Ph 2202 PURPOSE AND SCOPE
Ph 2202.01 Purpose. This part describes how the pharmacy board
conducts investigations as authorized by RSA 318:8-a, RSA 318:14-a, RSA 318:30,
and RSA 318:42.
Source. #12997, eff 3-5-20
Ph 2202.02 Scope. This section shall apply to any party licensed
by the pharmacy board or party licensed by another regulatory board that has
given investigatory authority to the pharmacy board of pharmacy under RSA
318:30.
Source. #12997, eff 3-5-20
PART Ph 2203 CONSUMER
COMPLAINTS
Ph 2203.01 Consumer Complaints.
(a)
Consumer complaints shall be filed using the administrative complaints
packet Ph 532, revised 11/1/18, containing “Complaint cover sheet form Ph 533,”
revised 11/1/18, “Pharmacy/Pharmacist Complaint Form” (Ph 534), revised
11/1/2018, and “Release of Medical Information form Ph 535,” revised 11/1/18,
available on the pharmacy board website at https://www.oplc.nh.gov/pharmacy/complaints.htm.
(b)
All complaints that meet the minimum technical requirements by
identifying a licensee and facts, which, if true, could be a violation subject
to the pharmacy board’s jurisdiction, shall be addressed by the pharmacy board
compliance staff. A report of investigation shall be issued to the pharmacy
board for review and further action if required.
(c)
Investigations shall be assigned by the pharmacy board
administrator/chief of compliance.
(d)
The pharmacy board shall dismiss any complaint that is not filed in
accordance with this chapter or that fails to state a cause of action pursuant
to RSA 318:30, VII.
Source. #12997, eff 3-5-20
PART Ph 2204 RESPONSES
Ph 2204.01 Quality Related Event Reports.
(a)
The board investigator shall issue “Quality Related Event (QRE) Report”
forms (Ph 530), revised 3/19, available on the pharmacy board’s website at
https://www.oplc.nh.gov/pharmacy/compliance.htm, to licensees for information
concerning the allegations of a complaint.
(b)
A licensee who received a “QRE Report” shall:
(1) If a pharmacist, pharmacy technician, or
person directly involved in the complaint, complete a “QRE Report” form;
(2) If a permit holder or corporate entity,
complete a separate “QRE Report”; and
(3) Sign and return the completed form to the
board investigator within 15 days of receipt pursuant to RSA 318:30 VIII.
Source. #12997, eff 3-5-20
PART Ph 2205 INVESTIGATIONS
Ph 2205.01 Licensees Subject to Investigations. The following licensees and medical providers
shall be subject to investigations:
(a)
Licensees of the pharmacy board including:
(1) Pharmacies, pharmacists, and pharmacy
technicians;
(2) Permit holders including:
a. Tele-pharmacy service providers;
b. Methadone clinics;
c. Infusion centers; and
d. All other facilities where medications are
administered, stored, or dispensed;
(3) Wholesalers, manufacturers, and distributors
of pharmaceuticals and pharmaceutical devices;
(4) Medical gas providers; and
(5) Out of state permit holders under RSA 318:37
II(d);
(b) Other medical providers pursuant to RSA
318:8-a and RSA 318-B, including:
(1) Physicians;
(2) Nurse practitioners;
(3) Physician assistants;
(4) Naturopaths;
(5) Podiatrists;
(6) Optometrists;
(7) Dentists; and
(8) Veterinarians with prescriptive authority.
Source. #12997, eff 3-5-20
Ph 2205.02 Investigations of a Complaint.
(a) Investigations into complaints shall be done
by pharmacy board commissioners and pharmacy board investigators in conjunction
with pharmacy board counsel and the administrative prosecution unit (APU) of
the NH department of justice.
(b)
Investigations shall focus on evidence of:
(1) Professional misconduct;
(2) Medication errors;
(3) Drug diversion;
(4) Violation of federal or state law and the
rules of the pharmacy board;
(5) FDA recalls;
(6) Noncompliance with the prescription drug
monitoring program;
(7) Unsanitary conditions, as per Ph 404.03 and
United States Pharmacopia (USP) 797; and
(8) Any condition, issue, or event related to the
practice of pharmacy, pharmaceutical product, or prescriptive device that
jeopardizes patient safety.
(c)
Investigators shall be authorized by the pharmacy board to:
(1) Obtain factual evidence to gain an
understanding of the complaint allegations;
(2) Conduct interviews with complainant,
respondent, or any other person thought to have knowledge of the incident which
gave rise to the complaint;
(3) Issue a “QRE Report” form to a party to the
complaint;
(4) Request
information from outside sources needed to investigate the complaint or issue
identified for investigation;
(5) Consult with pharmacy board counsel or the
APU; and
(6) Obtain any relevant information or data
regarding external variables that negatively impact the safe practice of
pharmacy including but not limited to:
a. Working conditions;
b. Staffing;
c. Training;
d. Facility conditions;
e. Equipment;
f. Power; and
g. The weather.
Source. #12997, eff 3-5-20
Ph 2205. Follow Up to Investigations.
(a)
The pharmacy board administrator/chief of compliance shall follow up
with a complainant as to the outcome of the investigation.
(b) Unfounded investigation reports and pharmacy
board actions shall be kept on file by the pharmacy board for 5 years. Founded
pharmacy board actions shall be attached to the license of the pharmacist or
pharmacist-in-charge and the pharmacy permit holder.
Source. #12997, eff 3-5-20
Ph 2205.04 Cost of the Investigation.
(a) All costs associated with an investigation
shall be reported to the respective regulatory board of the licensee for
tracking and potential assessing of investigation cost under RSA 332-G:11.
(b)
Costs involved with an investigation shall include:
(1) The cost of the investigator at a cost per
hour rate;
(2) The cost of the office staff timed at a cost
per hour rate;
(3) The cost of the pharmacy board counsel or APU
at cost per hour rate;
(4) Costs associated with travel of the above
persons; and
(5) Other costs as deemed necessary by the
pharmacy board.
Source. #12997, eff 3-5-20
PART Ph 2206 INVESTIGATION
REPORTS
Ph 2206.01 Reports of Investigation.
(a) Pharmacy board investigators shall
review all information concerning technically sufficient complaints and prepare
a report of investigation for pharmacy board review.
(b) The report of investigation shall include, but
need not be limited to:
(1) The name and license number or permit number
of all accused;
(2) The origin or nature of the allegations;
(3) All background information gathered during
the investigation;
(4) The sources of all information gathered in
the investigation;
(5) The results of the investigation;
(6) A summary of the investigation, when
relevant;
(7) The relevant laws and rules for consideration
of the complaint; and
(8) The investigator’s recommendation to the
pharmacy board for further action or for dismissal.
Source. #12997, eff 3-5-20
Ph 2206.02 Notification of Violations. If, in the course of their investigation, a
board investigator finds a violation of an administrative rule in plain sight,
then the investigator shall issue a violation notice pursuant to the rules in
Ph 2100.
Source. #12997, eff 3-5-20
Ph 2206.03 Prescription Drug Monitoring Program
Investigations. All pharmacy board
investigations concerning the prescription drug monitoring program shall be
referred to the respective board of the licensee upon completion.
Source. #12997, eff 3-5-20
PART Ph 2207 DISCIPLINARY
ACTION
Ph 2207.01 Pharmacy Board Action.
(a)
The pharmacy board shall review the completed reports of investigation
at their next scheduled pharmacy board meeting.
(b)
After review and after considering the factors set forth in (e) below,
the pharmacy board shall take action in one or more of the following ways:
(1) Refer to the board investigator for further
investigation;
(2) Dismiss the complaint;
(3) Issue a confidential letter of concern; or
(4) Impose disciplinary action in the form of
fines, public reprimands, additional education, suspension or revocation of
license, or other corrective action following notice and an opportunity for a
hearing or other action as stated in RSA 318:29, (IV) and (V). In considering which form of disciplinary
action to take, the pharmacy board shall consider the factors set forth in (e)
below.
(c)
In cases where the individual investigated is a licensee of another
board, the pharmacy board shall refer the report of investigation to that
respective board with recommendations.
(d) Disciplinary action concerning a reprimand,
fine, additional continuing education, the suspension or revocation of a
license, or any action resulting in a restriction on a pharmacy or pharmacist
license, shall be reported to the National Board of Pharmacy and National
Provider databases.
(e) In all cases of disciplinary action under Ph
2207.01(b) above, the pharmacy board shall consider:
(1) The nature of the offense;
(2) The purpose of the rule or statute violated;
(3) The licensee's state of mind at the time the
offense occurred;
(4) The potential harm to the public health;
(5) The deterrent effect upon other
practitioners;
(6) The licensee's willingness to cooperate with
the pharmacy board;
(7) The cost to the pharmacy board of any formal
disciplinary hearings which were necessary;
(8) The licensee's acknowledgment of his or her
wrongdoing; and
(9) The nature of any other disciplinary
sanctions imposed as a result of the offense in question.
Source. #12997, eff 3-5-20
Ph 2207.02 Administrative and Disciplinary Fines.
(a)
Persons subject to the disciplinary authority of the pharmacy board and
other persons subject to administrative fines or penalties under RSA 318:29, IV
or RSA 318:55, II shall after notice and an opportunity to be heard, be
assessed fines and penalties as authorized under RSA 318:29, IV.
In
considering the amount of fines and penalties to assess, the pharmacy board
shall consider the factors set forth in (b) through (i) below.
(b) The decision to impose a fine and the amount
of such fine shall depend on:
(1) The severity of harm to the
public posed by the violation;
(2) The number of concurrent or
repeated violations; and
(3) The frequency of violations
committed by the particular licensee, permit holder, or other person.
(c) Minor violations as listed in Ph 2109.02(d)
and on form Ph 542 “Minor Violation Notice” shall be subject to a fine of
$25.00 for each offense with a maximum of $250.00 per Ph 710.01 and Ph 710.02.
(d) Fines shall be paid within 15 days, or a
hearing shall be requested in front of the pharmacy board.
(e) When no violation of the same type has
occurred within the 5 years preceding the pharmacy board's notice to the
respondent, the fine assessed shall not exceed $1,000 per violation upon the
licensee or $2,000 per violation upon the permit holder.
(f) When a single disciplinary infraction of the
same type has occurred within the 5 years preceding the pharmacy board's notice
to the licensee, the fine assessed shall not exceed $2,000 per violation upon
the licensee or $3,000 per violation upon the permit holder.
(g) When more than one disciplinary infraction of
the same type has occurred within the 5 years preceding the pharmacy board's
notice to the licensee, the fine assessed shall not exceed $3,000 per violation
upon the licensee or $5,000 per violation upon the permit holder.
(h) In the case of continuing violations, a
separate fine shall be assessed for each day the violation continues, but the
total amount of the fine and the licensee's promptness and cooperativeness in
ceasing the prohibited conduct in question shall be considered in assessing the
daily fines.
(i) In all cases, the pharmacy board shall
consider:
(1) The nature of the offense;
(2) The purpose of the rule or
statute violated;
(3) The licensee’s state of
mind at the time the offense occurred;
(4) The potential harm to the
public health;
(5) The deterrent effect upon
other practitioners;
(6) The licensee’s willingness
to cooperate with the pharmacy board;
(7) The cost to the pharmacy
board of any formal disciplinary hearing which were necessary;
(8) The licensee’s
acknowledgement of his or her wrongdoing; and
(9) The nature of any other
disciplinary sanctions imposed as a result of the offense in question.
Source. #12997, eff 3-5-20
CHAPTER Ph 2300 INSTITUTIONAL
PHARMACY PRACTICE
PART Ph 2301 PRACTICES
Ph
2301.01 Definitions.
(a)
“Automated dispensing
machines” (ADM) means a mechanical system that performs operations or activities, other than
compounding or administration, relative to the storage, packaging, counting,
labeling, and dispensing of medications, and which collects, controls, and
maintains all transaction information.
(b)
" Automated medication supply system" means
an electronically controlled system that
performs operations or activities relative
to the storage and distribution of medications for administration and which collects, controls, and maintains all transaction information.
(c)
“Auto-verification” means when a medication is entered and released, it
is automatically verified in the electronic medical record, bypassing the
pharmacist verification step.
(d)
"Electronic identifier", for purposes of paragraph (a) above,
means a unique security code or other identifier which specifically identifies
the person entering information into a data processing system.
(e)
"Institution" means a health care facility which provides
inpatient care and includes:
(1) Hospitals;
(2) Nursing homes;
(3) Extended care facilities;
(4) Residential care facilities;
(5) Infirmaries;
(6) Hospice house;
(7) Correctional facilities; and
(8) Clinics.
(f) “Institutional
Pharmacy” means an area in an institution where drugs are stored, manufactured,
compounded, dispensed, or issued to other areas of department of the
institution.
(g) “Medication
order” means a verbal, telephonic, written, facsimile, or electronically
transmitted order provided by a prescribing practitioner for a specific drug to
be administered to an individual.
(h) “Prescription”
means a verbal, telephonic, written, or electronically transmitted order for
drugs, medicines, and devices by a practitioner licensed in the United States,
to be compounded and dispensed by licensed pharmacists in a duly registered
pharmacy.
Source. #13323, eff 1-5-22
Ph
2301.02 Permitting.
(a) A pharmacy permit shall be required for each
institution with an on-premise pharmacy.
Such permit shall be issued to an institution, who shall be licensed in
the state of New Hampshire.
(b)
When an institution procures prescription drugs for its patients only on
individual prescriptions for specific patients from an off-premises licensed pharmacy, the institution
shall not be required to obtain a pharmacy permit.
(c)
If an institution does not have a pharmacy on its premises, it may enter
into an agreement with a pharmacy licensed to provide such services. Such
agreement shall be in writing and shall state the policy and procedures as
required by Ph 2300. A copy of the
agreement shall be made available by the consultant pharmacist to the board
upon request. The consultant pharmacist
shall be responsible for the maintenance of all records and the compliance with
state and federal laws and rules governing the practice of pharmacy.
(d)
The pharmacist -in-charge and
the permit holder shall be responsible for compliance with federal, and
state laws related
to the practice of pharmacy.
Source. #13323, eff 1-5-22
Ph 2301.03
Practice Standards.
(a) An institutional permit
shall permit the pharmacy to dispense medications to the following, but is
not limited to:
(1) In-patients of
the institution;
(2) Staff or employees and their dependents, of the
institution;
(3) Interim supplies of medication to
outpatients in emergency situations;
(4) Home infusion therapy to registered outpatients not requiring
hospitalization; and
(5) Registered outpatients
receiving treatment in a hospital-based clinic.
(b)
If a pharmacist is on the premises, outpatient prescription services may be provided by the pharmacy, on a one-time,
no-refill basis, to an ambulatory care patient and any
patient who is being discharged with medications related to the patient's
hospitalization. Labeling for all outpatient prescriptions shall be according to RSA 318:47-a
and RSA 318-B: 11.
(c)
Members of the board and their agents shall inspect the pharmacy, drug
room, or medication room and all areas or departments of the institution where drugs are stored,
manufactured, compounded, dispensed,
or distributed to ensure:
(1) That adequate drug security and storage requirements are met;
(2) That proper records are maintained; and
(3) That the institution is in compliance with all state and federal drug and
pharmacy laws and rules.
(d)
Those institutions
obtaining prescription drugs only on individual prescriptions for specific
patients from an off-premise licensed pharmacy shall not be exempt from inspection.
(e)
Each institution shall have a pharmacy and therapeutics committee or a
comparable committee of its medical staff.
This committee shall be composed of representatives of the medical staff
and the pharmacist-in-charge or a licensed staff pharmacist designated by the
pharmacist-in-charge, and representatives of the administrative and nursing
departments. The pharmacy representative
shall be a voting member of the committee,
and the committee shall meet at least twice a year. The functions of this committee shall be to
establish the written policies and procedures governing medication management,
use of drugs, drug specifications, and drug
distribution.
(f)
The institutional pharmacy shall develop and
implement clinical pharmacy practice policies and procedures which provide optimum
comprehensive
medication management for patients.
(g)
An institutional pharmacy
shall have the ability to dispense
a generic or therapeutic equivalent or bio-similar, in
accordance with RSA 318:47dd, that has been approved by the pharmacy
and therapeutics committee or its equivalent per Ph 2301.03(a).
(h)
Pharmacists shall have the
ability to initiate or modify drug therapy by approved protocol
according to the institution policy.
Drug therapy initiated or modified by protocol shall be documented in
the medical record in accordance with the institutional policy
(i) Written policies and procedures shall
be adopted which establish the method utilized
in the procurement, storage,
preparation, and dispending of drugs in all areas
or departments of the institution
and shall be consistent with state and federal pharmacy
laws and rules.
(j) Medication
orders shall be reviewed by a pharmacist before the medication is initially dispensed
or medication orders
shall be reviewed by a pharmacist within
24 hours except when:
(1) A licensed independent
practitioner controls the ordering, preparation, and administration of
medications;
(2) In emergencies;
(3) When a pharmacist is
temporarily unavailable;
(4) By auto-verification by
policy;
(5) Those that are for
distribution of drugs for floor stock; or
(6) When distributed by the ADC.
(k) The review of medication orders may include, but shall
not limited to the following:
(1) Over-utilization or under-utilization;
(2) Therapeutic
duplication;
(3) Drug-disease
contraindication;
(4) Drug-drug interactions;
(5) Incorrect drug dosage or duration of drug treatment;
(6) Drug-allergy
interactions; and
(7) Clinical abuse or misuse.
(l)
Upon recognizing a clinical problem, the pharmacist shall take steps to
avoid or correct the problem.
Source. #13323, eff 1-5-22
Ph
2301.04 Environment. The
institutional pharmacy environment shall be detailed in the institution’s
policies and procedures and shall include at the minimum the following:
(a) How the institution will be enclosed and lockable and how the alarm is to be
engaged when not open 24 hours a day;
(b) How
the institution shall have adequate space necessary for the storage,
compounding, labeling, dispensing, and sterile preparation of drugs prepared in
the pharmacy;
(c) How the institution is to be arranged and
kept clean and in an orderly fashion;
(d) How the institution designates the sinks with
hot and cold running water which are available to all pharmacy personnel;
(e) The institutions locked storage system used
for all controlled substances;
(f)
The institutions designated areas for the storage of flammable and
caustic materials and how such areas shall meet the requirements set by local
and state fire laws; and
(g)
Describes designated areas for the preparation of sterile products if
sterile products are prepared.
Source. #13323, eff 1-5-22
Ph
2301.05 Drug Security. The institution drug security protocols shall
be detailed in the institution’s policies and procedures and shall include, but
not be limited to, the following:
(a) Drugs stored in any area or department of the facility shall be labeled
and kept secure
and shall be accessible only to authorized
personnel;
(b) When controlled drugs are stored in
authorized areas other than in the pharmacy, special locked storage for all
controlled substances requiring additional security shall be used;
(c) When using an automated medication supply
system, a secure system shall be
developed to assign, discontinue, or change personnel access codes;
(d) The
institution shall have a pharmacy labeling, inspection, and inventory
management system that ensures that outdated, mislabeled, or otherwise unusable
medications shall not be available for patient use. Inspections by the institutional pharmacy
shall be periodically performed but, at a minimum, no less than every 90 days;
and
(e) A retrievable record of each inspection
specified in (d) above shall be maintained in the pharmacy for at least 2 years
and shall be available to the board upon request;
(f)
Significant controlled
drug losses shall be reported to
the pharmacy within 24 hours and resolved within 72 hours. If the drug is determined to be missing or unaccounted
for, it shall be reported to the
board and DEA as specified by 21 CFR § 1301.76-b.
(g)
A pharmacy shall consider a controlled drug loss to be significant when:
(1) The percentage of dosage units
of a specific drug exceeds 2% of monthly dispensing volume; or
(2) Fifteen or more dosage units
are not accounted for.
(h)
The written report referenced in (a) shall contain at least the
following:
(1) Date of discovery;
(2) Identity of the person making
the discovery;
(3) Name and location of the
pharmacy from which the drug is missing;
(4) Name, strength, dosage form,
NDC, and quantity of the
missing drug(s); and
(5) Cause of the controlled drug
loss as determined by the investigation.
Source. #13323, eff 1-5-22
Ph
2301.06 Access to the Pharmacy.
(a) Only a pharmacist shall open and close the pharmacy for dispensing. The pharmacist-incharge
of each institutional pharmacy shall establish written policies identifying
specific situations when authorized
personnel may be present in the pharmacy
in the absence of a licensed pharmacist.
(b) In the absence of a pharmacist and in
accordance with RSA 318:38, I, registered
nurses, designated for this purpose by the pharmacist-in-charge, may obtain
from the pharmacy or night cabinet such drugs as needed in an
emergency when these drugs are not available in floor stock supplies, as follows:
(1) The authorized nurse may enter the pharmacy
area and remove
the following:
a. A drug in its original container
or a drug prepackaged for use within the facility subject to these rules; or
b. An emergency
supply of a drug from the original
container to be administered to a
specific patient.
(2) The authorized
nurse shall document the physician's medication order using a suitable form
recording the following:
a. Name and strength
of the drug taken;
b. Dosage form taken;
c. Quantity taken;
d. Time and date of withdrawal;
e. Patient name and
location, where applicable; and
f. Nurse's signature.
(3) The nurse shall identify
the bulk container from which the medication was taken or a representative sample of the unit-dose medication. In the event that a representative sample of a medication is
not available to be left, then a photocopy of the label of the medication shall
be acceptable.
Source. #13323, eff 1-5-22
Ph
2301.07 Drug Control In Ambulatory
Patient Treatment Areas.
(a)
In the ambulatory patient treatment areas, a practitioner authorized under any other law of the state
of New Hampshire may dispense drugs for the immediate needs of the
patient, with no more than a maximum of
a 72-hour supply, except for the following:
(1) For Schedule II-IV, controlled
substances, a maximum of 48-hour supply;
(2) Multi-dose forms of drugs such as, but not
limited to, inhalers or epi-pens;
(3) For a
full course of medication therapy needed to treat patients under a public
health incident; or
(4) For a
full course of medication therapy needed to treat patients of sexual assault.
(b)
If a licensed pharmacist is on the
premises, that pharmacist may fill one-time, full amount,
non-refillable prescriptions for patients for medications related to the
ambulatory patient treatment visit.
(c)
A readily retrievable record shall be made of all dispensing of controlled drugs
in the ambulatory patient area and contain the following:
(1) Name and address
of the patient;
(2) Name of the medical practitioner;
(3) Name, strength, and quantity of the drug(s);
(4) Date of administration or dispensing; and
(5) Signature
or electronic identifier, as defined in Ph 2301.0l(b), of the agent
removing the drug(s) from the inventory.
Source. #13323, eff 1-5-22; ss by #13324, EMERGENCY
RULE, eff 1-5-22, EXPIRED: 7-4-22 (#13323 effective again pursuant to RSA
541-A:18, V); ss by #13436, eff 8-18-22
Ph 2301.08 Investigational Drugs. lnvestigationa1 drugs for research
shall be used only under the authority of the principal
investigator. Such drugs shall be
controlled by the pharmacy and shall be labeled according to the research
protocols. The principal investigator
shall provide essential information on such drugs to the current treatment team.
Source. #13323, eff 1-5-22
Ph
2301.09 Purchase of
Drugs.
(a)
The pharmacist-in-charge, with
the consent of the institution's pharmacy and therapeutics committee or comparable committee
of its medical staff, shall be responsible for the
quality of all drugs,
biologicals, and pharmaceutical chemicals.
(b)
Drugs including, but not limited to, radiopharmaceuticals, blood products, radiopaque media, biologicals, pharmaceutical chemicals,
intravenous and irrigation drugs, and medical
devices may be exempted from the approval and
control of the pharmacist-in-charge by the institution's pharmacy and
therapeutics committee or a comparable
committee.
Source. #13323, eff 1-5-22
CHAPTER Ph 2400 PHARMACIST
INITIATION AND DISPENSING OF HORMONAL CONTRACEPTIVES
PART Ph 2401 PURPOSE, SCOPE, AND COOPERATION
Ph
2401.01 Purpose. The purpose of this chapter is to promulgate
procedures regarding the dispensing of oral contraceptives, via a standing
order, pursuant to RSA 318:47-1.
Source. #13343, eff 2-17-22
Ph
2401.02 Scope. The rules shall regulate pharmacists licensed
by the New Hampshire board of pharmacy in the prescribing and dispensing of
hormonal contraceptives without a prior prescription.
Source. #13343, eff 2-17-22
Ph
2401.03 Cooperation. In order to clarify, improve, and support
appropriate pharmacist prescribing, the board shall periodically review
prescribing standards and practices and seek recommendations in consultation
with designated representatives from the New Hampshire board of medicine, New
Hampshire board of nursing, and the department of health and human services.
Source. #13343, eff 2-17-22
PART Ph 2402 DEFINITIONS
Ph 2402.01 Definitions.
(a) "Board" means the New Hampshire
pharmacy board as established by
RSA 318:1, III and RSA 318:2.
(b) “Clinical visit” means a consultation with a
healthcare practitioner, other than a pharmacist, for women’s health, which
address contraception and age-appropriate screening.
(c) “Hormonal contraceptives” means pills,
patches, and rings which the United States Food and Drug Administration (FDA)
classifies as available by prescription for the purpose of contraception or
emergency contraception. It does not
include similar items classified as “over the counter” by the FDA, including intrauterine devices, shots, or intradermal implants.
(d) “Hormonal Contraceptive Self-Screening
Questionnaire” means the screening tool approved by the board on November 17,
2021 and completed by the patient and utilized by a licensed pharmacist to
access whether to dispense a hormonal contraceptive via standing order.
(e) “Licensed pharmacist” or “pharmacist” means
“licensed pharmacist” or “pharmacist” as defined in RSA 318:1, VII, namely,
“when not otherwise limited, means a person holding a license under RSA 318:18
and who is, therefore legally authorized to practice the profession of pharmacy
in this state.”
(f) “Model statewide protocol” means a protocol
for dispensing hormonal contraceptives pursuant to RSA 318:47-1 jointly
developed by the board of medicine, the board of nursing,
and the department of health and human services.
(g) "Outpatient
contraceptive services" means hormonal contraceptive prescribing and
dispensing services provided by the licensed pharmacist as specified in RSA 318:47-1.
(h) “Practitioner” or “licensed practitioner”
means “practitioner” or “licensed practitioner” as defined in RSA 318:1, XV,
namely, “means any person who is lawfully entitled to prescribe, administer,
dispense, or distribute legend drugs to patients.”
(i) “Standard algorithm”
means the “Standard Procedures Algorithm for New Hampshire RPH Prescribing of
Contraceptives” dated 11/17/2021 developed based upon the following select
procedures and recommendations adopted by the U.S. Centers for Disease Control
and Prevention:
(1) U.S.
Medical Eligibility Criteria (MEC) for Contraceptive Use, revised July 29, 2016, available as specified in Appendix
B; and
(2) U.S.
Selected Practice Recommendations (SPR) for Contraceptive Use, revised July 29,
2016, available as specified in Appendix B.
(j) “Standing order” means a written and signed
protocol authored by one or more physicians licensed under RSA 329:12 or one or
more advanced practice registered nurses licensed under RSA 326-B:18.
Source. #13343, eff 2-17-22
PART Ph 2403 PHARMACIST
REQUIREMENTS FOR CERTIFICATION
Ph 2403.01 Pharmacist
Requirements. In order to dispense hormonal contraceptives, a pharmacist
shall:
(a) Complete an
Accreditation Council for Pharmacy Education approved training program for
hormonal contraceptives;
(b) Have a private area designed to maintain
privacy and confidentiality of the patient and is not susceptible to
distractions of the pharmacist; and
(c) Construct, maintain,
and follow written policies and procedures that establish a course of action which the pharmacist shall follow,
that includes, but is not limited to, information regarding:
(1) Adverse reactions;
(2) Compliance
with the U.S. MEC, U.S. SPR and the “Standard Procedures Algorithm for New
Hampshire RPH Prescribing of Contraceptives”, dated November 17, 2021,
available on the boards web site, https://www.oplc.nh.gov/board-pharmacy-forms-and-documents;
(3) Patient confidentiality;
(4) How to
appropriately screen patients and determine when to refer to a healthcare
provider; and
(5) The process
to dispense the hormonal contraceptive.
Source. #13343, eff 2-17-22
PART Ph 2404 PROCEDURES FOR PRACTICE
Ph 2404.01 Initiation and Dispensing
Procedure. A pharmacist who engages
in hormonal contraceptive initiation and dispensing shall:
(a) Provide each patient who seeks hormonal
contraceptives with a board-supplied standardized
information sheet, written in plain language, regarding the hormonal
contraceptive being dispensed, which includes, but is not limited to:
(1) An
indication for the use of the hormonal contraceptive;
(2) The
importance of follow up care; and
(3) Health care
referral information;
(b) Have the patient complete an initial
screening using the “Hormonal Contraceptive Self-Screening Questionnaire” dated
November 17, 2021, available on the boards web site, https://www.oplc.nh.gov/board-pharmacy-forms-and-documents;
(c) Have the patient complete any renewal
screening identified through the use of
the “Hormonal Contraceptive Self-Screening Questionnaire” dated November 17,
2021, available on the boards web site, https://www.oplc.nh.gov/board-pharmacy-forms-and-documents;
(d) Ensure each patient is an appropriate
candidate for receiving hormonal contraceptives,
as dictated by the U.S. MEC, U.S. SPR revised July 29, 2016, available as
specified in Appendix B and the “Standard Procedures Algorithm for New
Hampshire RPH Prescribing of Contraceptives”, dated November 17, 2021 available
on the boards web site, https://www.oplc.nh.gov/board-pharmacy-forms-and-documents, and refer to a
health care practitioner, if appropriate;
(e) Identify the medication being dispensed to
the patient and counsel the patient regarding, but not limited to, adverse
effects, follow up appointments, and the instructions for use;
(f) Provide each patient with an "After
Visit" summary sheet;
(g) Based upon a patient’s request, provide
electronically, in writing, or fax within 24 hours to the patient’s primary
care practitioner, or a pharmacist-referred practitioner if the patient does not have a primary care
practitioner, a copy of the NH Self-Screening Questionnaire, the hormonal
contraceptive that has been prescribed and dispensed to the patient, and any
other relevant notes; and
(h) Based upon a patient’s request, provide the
patient who does not have a primary care practitioner and does not wish to be
referred to a primary care practitioner a written copy of his or her record,
which shall include, but not be limited to, the NH Self-Screening
Questionnaire.
Source. #13343, eff 2-17-22
Ph 2404.02 Recordkeeping Procedures.
(a) A pharmacist engaging in the initiation and
dispensing of hormonal contraceptives shall maintain patient records for a minimum of 7 years.
(b) Maintained patient records shall, at a minimum, include:
(1) The name
and date of birth of the patient;
(2) A copy of
the “Hormonal Contraceptive Self-Screening Questionnaire” dated November 17,
2021, completed by the patient;
(3) Evidence that the patient was screened;
(4) Counseling information
relayed to patient;
(5) Based upon patient request, evidence that the practitioner was
provided with the self- screening questionnaire and notified of the drug dispensed;
(6) Name, dose,
strength, quantity, and directions of the hormonal contraceptive dispensed; and
(7) Signature of the patient.
Source. #13343, eff 2-17-22
PART Ph 2405 STANDARDS
OF PRACTICE
Ph 2405.01 Patient Age Requirements. Pharmacists shall only dispense hormonal
contraceptives to a person who is:
(a) At least 18 years of age, regardless of
whether the person has evidence of a previous prescription from a primary care
practitioner or a women’s health care practitioner for a hormonal contraceptive; or
(b) Under 18 years of age, only if the person has
evidence of a previous prescription from
a primary care practitioner or women’s health care practitioner for a hormonal
contraceptive.
Source. #13343, eff 2-17-22
Ph 2405.02 Pharmacist Standards of Practice.
(a) Licensed pharmacists who dispense hormonal
contraceptives shall comply with the board’s rules, U.S. MEC, U.S. SPR, and the “Standard Procedures Algorithm for New
Hampshire RPH Prescribing of Contraceptives”, dated November 17, 2021 available
on the boards web site, https://www.oplc.nh.gov/board-pharmacy-forms-and-documents.
(b) The board’s rules, U.S. MEC, U.S. SPR, “Standard Procedures Algorithm for New
Hampshire RPH Prescribing of Contraceptives”, dated November 17, 2021 available
on the boards web site, https://www.oplc.nh.gov/board-pharmacy-forms-and-documents, and any other ACPE shall be kept on the pharmacy premises and be
available electronically for board review upon request.
Source. #13343, eff 2-17-22
PART Ph 2406 IMMUNITY
Ph 2406.01 Immunity. The board shall not penalize licensed pharmacists under this
chapter for following standing orders that contains a defect as long as the
requirements in Ph 2400 and RSA 318:47-1 are satisfied.
Source. #13343, eff 2-17-22
CHAPTER Ph 2500
AUTOMATED PHARMACY SYSTEMS
PART Ph 2501 PURPOSE AND SCOPE
Ph 2501.01 Purpose. The provisions of this chapter shall
establish procedures for the use, documentation, security, maintenance, and
monitoring of automated pharmacy systems.
Source. #13465, eff 12-19-22
Ph 2501.02 Scope. These
rules shall apply to the placement of automated pharmacy systems in community
remote sites, hospitals, and emergency drug kits, for the purpose of storage
and dispensing of controlled and non-controlled prescription drugs.
Source. #13465, eff 12-19-22
PART
Ph 2502 DEFINITIONS
Ph 2502.01 Definitions. Except where the
context makes another meaning manifest, the following definitions shall apply:
(a)
“Automated dispensing system”
means an automated pharmacy system that is a mechanical system that performs
operations or activities, other than compounding or administration, relative to
the storage, packaging, counting, labeling, and dispensing of medications, and
which collects, controls, and maintains all transaction information. These do
not include prepackaging or repacking devices;
(b) “Provider pharmacy” means a pharmacy,
licensed by the NH board of pharmacy, that provides pharmacy services by using
an automated pharmacy system at a remote site or at the pharmacy site for use
outside of pharmacy hours of operation in licensed pharmacy space;
(c) “Remote site” means a NH licensed long-term
care facility, hospice facility, hospital, or state or county correctional
facility, or other health care facilities that is not located at the same
location as the provider pharmacy, at which pharmacy services are provided
using an automated pharmacy system.
Source. #13465, eff 12-19-22
PART Ph 2503
REGISTRATION
Ph 2503.01 Application.
(a) Community pharmacies and provider pharmacies
shall use application form “Automated Pharmacy System Registration Form”, dated
August 2022, to apply for placement of an automated pharmacy system at the
desired location.
(b) The requirements on the form include:
(1) Name and
address of the provider pharmacy;
(2) DEA number;
(3) If a remote
location, the name and address of the remote site;
(4) Desired
location in the facility where Automated Pharmacy System (APS) will be located;
and
(5) Name of
pharmacist in charge or consultant pharmacist.
(c)
After receipt and review of the fully completed application the board
shall approve or deny the location of the automated pharmacy system within 30
days.
Source. #13465, eff 12-19-22
PART Ph 2504
AUTOMATED PHARMACY SYSTEMS IN COMMUNITY SETTINGS
Ph 2504.01 Location,
Access, and Other System Requirements.
(a) The automated pharmacy system shall be
located within the prescription department, adjacent to the prescription
department, or shall be located on the establishment of the licensed pharmacy,
and the operation of the automated pharmacy system shall be under the
supervision of a pharmacist.
(b) An automated pharmacy system that is not
located within the prescription department shall be operated as an extension of
the licensed pharmacy and the automated pharmacy system shall not require an
independent and separate community pharmacy permit.
(c) Access to the automated pharmacy system shall
be monitored and controlled as follows:
(1) Proper
identification controls, including electronic passwords, biometrics, or other
coded identification shall be utilized;
(2) Access control
shall be limited and authorized by the pharmacist-in-charge or their authorized
designee;
(3) The
pharmacist-in-charge or their designee may have the authority to stop or change
access at any time;
(4) The
pharmacist-in-charge shall maintain a current and immediately retrievable list
of all persons who have access and the limits of their access; and
(5) Review of user
access reports shall be conducted periodically to ensure that access by persons
no longer employed has been appropriately disabled.
(d) Access for maintenance or repair shall be
pre-approved by the pharmacist-in-charge and shall be performed under the
continuous supervision of a person with appropriate access authorization.
(e)
A process of filling and stocking the system with drugs using an
electronic or hard copy record of medication filled into the system shall
include the product identification, lot number, and expiration date.
(f)
The automated pharmacy system shall have adequate security and
safeguards to prevent and detect unauthorized use or access, in order to
protect patient privacy including the patients records and prescription drug
orders.
(g)
The system shall ensure that each finished, filled prescription is
dispensed in compliance with all New Hampshire pharmacy laws including but not
limited to an electronic or hard copy record of prescription dispensing through
the system, labelling requirements, and counselling.
(h)
The system shall provide electronic identification or individual log in
and passwords for patients to access the system.
(i) The system shall include a mechanism to
ensure that the patient or an authorized agent of the patient has a means to
communicate with a pharmacist regarding the medical drug product.
(j) The means of communication shall include at
least one of the following:
(1) In person;
(2) Telephone; or
(3) Interactive
face to face electronic communication.
(k) The system shall maintain a readily
retrievable electronic record to identify all pharmacists, pharmacy interns,
licensed advanced pharmacy technicians, certified pharmacy technicians, and
registered pharmacy technicians involved in the dispensing of a prescription.
(l)
After-hours access by the patient shall permitted provided all the
criteria in (f) and (g) are followed.
(m)
No automated pharmacy system shall be installed in compliance with the
board’s rules.
Source. #13465, eff 12-19-22
PART Ph 2505
AUTOMATED PHARMACY SYSTEMS IN REMOTE SITES
Ph 2505.01 Requirements
for the Automated Systems in Remote Sites.
(a)
A provider pharmacy may provide pharmacy services to remote sites
properly licensed in New Hampshire through the use of an automated pharmacy
system.
(b)
An automated dispensing system shall only be used to provide pharmacy
services to an inpatient or a resident of the remote site.
(c)
The pharmacy shall have security to prevent unauthorized access. Such
method shall include at least one of the following:
(1) Electronic
password(s);
(2) Biometric
identification (optic scanning or fingerprint); or
(3) Other coded
identification.
(d) All the drug inventory stored in the
automated pharmacy system shall be owned by the provider pharmacy.
(e) An automated dispensing system shall be under
the supervision of a licensed pharmacist or licensed advanced pharmacy
technician employed by the provider pharmacy
who does not need to be the individual need not be physically present at the
remote site if the system is supervised electronically.
(f)
The pharmacist in charge and permit holder shall ensure that the
automated dispensing system complies with RSA 318-B and 21 C.F.R., relating to
the regulation of controlled substances, for each automated pharmacy system
that contains a controlled substance.
(g)
The pharmacist in charge shall ensure that the use of an automated
dispensing system does not compromise patient confidentiality.
(h)
A medicinal drug may be removed from an automated dispensing system for
administration to a patient only after a prescription or order has been
received and approved by a pharmacist at the provider pharmacy.
(i)
A pharmacist at the provider pharmacy shall control all operations of
the automated dispensing system and approve release of the initial dose of a
prescription or order.
(j)
A subsequent dose from an approved prescription or order may be released
without additional approval of a pharmacist except that any change made in a
prescription or order shall require a new approval by a pharmacist to release
the drug.
(k)
A pharmacist at the provider pharmacy shall comply with the patient
record requirements and prospective drug use review requirements in the Ph 700
rules for every drug delivered through an automated pharmacy system.
(l)
The stocking or restocking of a medicinal drug in an automated
dispensing system at the remote site shall be completed by a pharmacist,
licensed advanced pharmacy technician, certified pharmacy technician, registered
pharmacy technician, or designated health care professional except as provided
in (n) below.
(m)
If the automated dispensing system uses removable cartridges or
containers to store the drug, the stocking or restocking of the cartridges or
containers may occur at the provider pharmacy and be sent to the remote site to
be loaded by personnel designated by the pharmacist if:
(1) A pharmacist or
licensed advanced pharmacy technician verifies the cartridge or container has
been properly filled and labeled;
(2) The individual
cartridge or container is transported to the remote site in a secure,
tamper-evident container; and
(3) The automated
pharmacy system uses bar code verification, electronic verification, or similar
process to assure that the cartridge or container is accurately loaded into the
automated dispensing system by pharmacist, a certified pharmacy technician,
registered technician, licensed advanced pharmacy technician, or designated
health care professional.
(n)
A medicinal drug that has been removed from the automated dispensing
system shall not be replaced into the system unless a pharmacist or licensed
advanced pharmacy technician has examined the medication, packaging, and
labeling and has determined that reuse of the medication is appropriate.
(o)
If a provider pharmacy intends to store a controlled substance in an
automated dispensing system:
(1) No
additional DEA registration shall be required outside of the dispensing
pharmacy if used as an e-kit only in accordance with Federal Register 24128; and
(2) It may utilize
one DEA registration to include multiple automated pharmacy systems located at
a single address.
(p)
Controlled substances shall only be released from the automated
dispensing system to authorized personnel by a supervising pharmacist in
compliance with provisions in 21 CFR 1306.11 and 21 CFR 1306.21.
(q)
A provider pharmacy shall only store a medicinal drug at a remote site
within an automated dispensing system which is locked by a mechanism that
prevents access to a drug or to data by unauthorized personnel.
(r)
Access to the drugs shall be limited to a pharmacist, certified pharmacy
technician, registered pharmacy technician, licensed advanced pharmacy
technician employed by the provider pharmacy, or licensed personnel in the
facility or institution who are authorized to administer medications.
(s)
An automated dispensing system that contains a controlled substance
shall prohibit simultaneous access to multiple drug entities, drug strengths,
or dosage forms of controlled substances.
(t)
If an automated dispensing system is utilized for both a medication
order for a specific patient and a non-controlled emergency medication for
which the review of a pharmacist is not required the record shall include:
(1) The name of the
medication;
(2) The patient’s
name;
(3) The name of the
prescriber;
(4) The name of the
person who accessed the automated dispensing system; and
(5) The date and
time of the release.
(u) The record of transactions with the automated
dispensing system shall be maintained in a readily retrievable manner.
(v)
The record shall be available to a compliance investigator from the
office of professional licensure and certification or the board of pharmacy.
(w)
The record shall include:
(1) Name or
identification of the patient or resident;
(2) Name, strength,
and dosage form of the drug product released;
(3) Quantity of
drug released;
(4) Date and time
of each release of a drug;
(5) Prescription
number or order number;
(6) Name of
prescribing practitioner;
(7) Identity of the
pharmacist who approved the prescription or order; and
(8) Identity of the
person to whom the drug was released.
(x) Records of all transaction with the automated
dispensing system shall be maintained for 4 years.
Source. #13465, eff 12-19-22
PART Ph 2506
AUTOMATED PHARMACY SYSTEMS FOR EMERGENCY KIT USE
Ph 2506.01 Definitions.
(a) “Automated electronic emergency drug kit”
means an automated pharmacy system used for the immediate administration to
patients or residents upon the order of a practitioner as set forth in rules
adopted under RSA 151:2.
Ph 2506.02 Automated
Pharmacy Systems Emergency Kit Use Requirements.
(a)
Automated electronic emergency drug kits located in remote sites shall:
(1) Provide real
time electronic communication to the provider pharmacy;
(2) Have a method
to ensure security of the system to prevent unauthorized access. Such method shall include the use of
electronic passwords, biometric identification or other coded identification;
(3) Be supervised
by a New Hampshire licensed pharmacist or licensed advanced pharmacy technician
employed by the provider pharmacy;
(4) Have all the
drug inventory stored in the automated dispensing system shall be owned by the
provider pharmacy;
(5) When placed in
non-federally registered long term care facilities and other health care
institutions be deemed to be in compliance with the Comprehensive Drug Abuse
Prevention and Control Act of 1970 provided that:
a. Controlled
substances selected and stored in the automated electronic emergency drug kits
is in quantities deemed necessary and jointly approved by the pharmacist in
charge and the consultant pharmacist, medical director, and director of nursing
services;
b. Controlled
substances in emergency drug kits are limited to a maximum of 250 total dosage
units per kit;
c. Only the
director of nursing services, registered nurse on duty, licensed practical
nurse on duty, pharmacist, registered pharmacy technician, or New Hampshire
licensed health care professionals authorized under regulations associated with
their scope of practice shall have access to controlled substances stored in an
automated electronic emergency drug kit; and
d. Controlled
substances are only released from the automated electronic emergency drug kit
to authorized personnel by a supervising pharmacist in compliance with
provisions in 21 CFR 1306.11 and 21 CFR 1306.21;
(6) Be able to
automatically generate notice to the provider pharmacy whenever the kit is
accessed and provide at least the following information:
a. Name of
individual accessing the kit;
b. Date and time
the kit was accessed;
c. Name, strength,
and quantity of the drug removed; and
d. Name of the
patient for whom the drug was administered;
(7) Be restocked by
a licensed pharmacist, licensed pharmacist assistant, physician, physician
assistant, advanced practice nurse, registered nurse, certified pharmacy
technician, or an advanced practice technician;
(8) Have a system
to allow for records to be retrievable and in a readily available manner; and
(9) Allow for the
storage of records of all transactions with the automated pharmacy system for
at least 4 years.
(b) In the instance where an automated system is
unavailable the following criteria shall be met:
(1) Controlled substances shall be stored in the
emergency drug kit as deemed necessary and jointly approved by the pharmacist
in charge and the consultant pharmacist, medical director, and the director of
nursing services;
(2) The source from which controlled substances
for emergency drug kits are obtained shall be a DEA registered hospital,
clinic, pharmacy, or practitioner;
(3) Controlled substances in emergency drug kits
shall be limited to a maximum of 250 dosage units per kit;
(4) The emergency drug kit containing controlled
substances shall be closed with a tamper proof seal and kept in a locked
medication room, cart, or closet;
(5) Only a NH licensed healthcare professional
authorized under regulations associated by their scope of practice shall have
access to the drug kit;
(6) Controlled substances in emergency drug kits
shall be administered to patients only by authorized personnel and only as
expressly authorized by an individual practitioner and in compliance with the
provisions of 21 CFR 1306.11 and 1306.21;
(7) A usage record shall be contained in the
emergency drug kit for each separate drug included and shall be completed by
the nursing staff when using any controlled substance or substances from the
kit;
(8) The pharmacist shall receive a copy of all
completed usage records and keep those records on file for a period not less
than 2 years;
(9) When the emergency drug kit is opened a shift
count shall be completed by the member of the nursing staff on all controlled
substances until the emergency drug kit is resealed by the consultant
pharmacist;
(10) Shift counts of the controlled substances
contained in the emergency kit shall not be required when the kit is sealed;
and
(11) The pharmacist shall check the controlled
substances in the emergency drug kit at least once a month and so document
inside the kit.
Source. #13465, eff 12-19-22
PART Ph 2507 AUTOMATED PHARMACY SYSTEMS FOR HOSPITAL
SETTINGS
Ph
2507.01 Automated
Pharmacy Systems for Hospital Setting Requirements.
(a) Hospital permit holders shall have policies
in place to:
(1) Stop or change
access to the system at any time;
(2) Maintain a
current and immediately retrievable list of persons who have access and the
limits of that access;
(3) Ensure the
proper identification of controls, including electronic passwords or an
electronic identifier shall be utilized and access control shall be limited and
authorized by the pharmacist-in-charge, director, or their authorized designee;
(4) Review user
access reports conducted periodically ensuring access by persons no longer
employed have been appropriately disabled; and
(5) Allow for
access for maintenance or repair to be pre-approved by the pharmacist-in-charge
or director which is being performed under the continuous supervision of a
person with appropriate access authorization.
(b) The automated dispensing system shall have
adequate system security and safeguards to prevent and detect unauthorized
access or use, maintain the integrity of patient records and prescription drug
orders, and protect patient privacy.
(c) The filling, stocking, or replenishing of
drugs into the automated dispensing system shall be accomplished by a
pharmacist, certified technician, licensed advanced pharmacy technicians,
registered technicians, or nurse and shall occur through bar coding or other
electronic technology used for item identification.
(d) The automated medication supply system shall
be able to generate a record on demand of drugs filled into the system that
includes at least:
(1) Date;
(2) Drug name;
(3) Dosage form;
(4) Strength;
(5) Quantity;
(6) Drug
expiration; and
(7) The name or
initials of the authorized individual filling the system.
(e) If the automated medication supply system
uses removable cartridges or containers to hold bulk drugs, the prepackaging of
the cartridges or containers shall occur in the pharmacy where the original
inventory is maintained.
(f) The prepackaged cartridges or containers may
be sent to a remote dispensing site to be loaded into an automated dispensing
system by a pharmacist or technician if:
(1) A pharmacist or
licensed advanced pharmacy technician has verified the proper filling and
labelling of the cartridge or container;
(2) The individual
cartridges or containers are transported to the automated dispensing system in
a secure, tamper-evident container; and
(3) The automated
dispensing system utilizes technologies to ensure that the cartridges or
containers are accurately loaded.
(g)
Drugs stored in an automated dispensing system shall be contained in the
manufacturers’ sealed, original packages or in prepackaged unit-of use
containers and shall be labelled as required.
(h)
A pharmacist shall review the drug order prior to any removal from the
system of a drug intended for immediate patient administration except if:
(1) The system is
being used as an afterhours cabinet for drug dispensing in the absence of a
pharmacist;
(2) The system is
being used in place of an emergency kit;
(3) The drug is a
subsequent dose from a previously reviewed drug order;
(4) The prescriber
controls the drug administration process in procedural areas; or
(5) The drugs are
approved for override by the pharmacy director, pharmacist in charge, or
designee.
(i)
The automated dispensing system shall provide a mechanism for securing
and accounting for drugs removed from and subsequently returned to the system.
(j)
A drug removed from the system but not administered to a patient shall
be returned as follows if unopened, sealed, intact and stored in compliance
with the drug storage product rule to:
(1) The pharmacy
immediately;
(2) The automated
dispensing system for immediate reuse by authorized personnel in hospitals
utilizing bar code scanning technology at the bedside or the automated pharmacy
system;
(3) The automated
dispensing system return bin; or
(4) An alternative,
secure storage area until returned to the pharmacy.
Source. #13465, eff 12-19-22
CHAPTER
Ph 2600 PHARMACIST INITIATION AND DISPENSING OF NICOTINE CESSATION THERAPY
PART Ph 2601 PURPOSE, SCOPE,
AND COOPERATION
Ph 2601.01
Purpose. The purpose
of this section is to promulgate procedures regarding the dispensing of
nicotine cessation therapy, via a standing order, pursuant to RSA 318:47-m.
Source. #13559, eff 4-12-23
Ph
2601.02 Scope.
The rules shall regulate pharmacists licensed by the New Hampshire
pharmacy board of pharmacy in the prescribing and dispensing of
nicotine cessation therapy without a prior prescription.
Source. #13559, eff 4-12-23
Ph 2601.03
Cooperation. In order to clarify,
improve, and support
appropriate pharmacist
prescribing, the board shall periodically review prescribing standards and
practices and seek recommendations in
consultation with designated representatives from the New Hampshire board of medicine, New Hampshire
board of nursing, and the department of health and human services.
Source. #13559, eff 4-12-23
PART Ph 2602
DEFINITIONS
Ph 2602.01
Definitions.
(a)
“Nicotine cessation therapy” means medications, which the United States
Food and Drug Administration (FDA) classifies as available by prescription or
without a prescription, for the purpose of nicotine cessation.
(b) "Standing order" means “standing
order” as defined in RSA 318:47-m, I namely “a written and signed protocol
authored by a physician licensed under RSA 329:12, a physician assistant
licensed under RSA 328-D:2, or an advanced practice registered nurse licensed
under RSA 326-B:18. The agreement shall specify a protocol allowing a licensed
pharmacist to provide nicotine cessation therapy under the delegated
prescriptive authority of the physician, physician assistant, or APRN, a
mechanism to document screening performed and the prescription in the patient's
medical record, and include a plan for evaluating and treating adverse events.
The prescriptions shall be considered a legitimate medical purpose in the usual
course of professional practice.”
(c)
“Licensed pharmacist” or “pharmacist” means “licensed pharmacist” or
“pharmacist” as defined in RSA 318:1,
VII, namely, “when not otherwise limited, means a person holding a license under RSA 318:18 and who is, therefore legally
authorized to practice the profession of pharmacy in this
state.”
(d)
“Board" means the New Hampshire pharmacy board created by RSA 318.
Source. #13559, eff 4-12-23
PART Ph 2603
PHARMACIST REQUIREMENTS FOR CERTIFICATION
Ph 2603.01 Pharmacist Requirements. In order to dispense nicotine cessation therapy, a pharmacist shall:
(a)
Hold a current license to practice as a pharmacist or be registered as a
pharmacy intern under RSA 318:15-b in New Hampshire;
(b)
Possess at least $1,000,000 of professional liability insurance
coverage;
(c)
Complete an Accreditation Council for Pharmacy Education (ACPE)
accredited educational training program related to nicotine cessation;
(d)
Provide notice to the primary care provider, when designated by the
patient, of the administration of nicotine cessation therapy;
(e)
Have a current standing order authored and signed by a physician,
physician assistant, or advanced practice registered nurse (APRN) ;
(f)
Construct, maintain, and follow written
policies and procedures that establish a
protocol that includes patient evaluation, treatment, dispensing, and follow
up.
(g)
Recommend the patient seek additional assistance for behavior change,
including but not limited to the NH Smoke Free helpline (1-800-quit-now) and
web-based programs such as “Quit Now” located at http://quitnownh.org.
Source. #13559, eff 4-12-23
PART Ph 2604 PHARMACIST RECORD KEEPING PROCEDURES
Ph 2604.01 Recordkeeping Procedures. A pharmacist engaging in the initiation and dispensing of nicotine cessation
therapy shall maintain records for a minimum of 4 years that include at least the following:
(a)
A copy of the “NH
Tobacco Cessation Self-Screening Patient Intake Form” completed by the patient;
and
(b)
All notes the pharmacist made related to the assessment and treatment
plan.
Source. #13559, eff 4-12-23
Ph 2604.02 Forms.
(a)
The “NH Tobacco Cessation Self-Screening Patient Intake Form” shall
contain the following:
(1) Name of the patient;
(2) Date of birth of the patient;
(3) Age of the patient;
(4) The date completed;
(5) Blood pressure and mmHg at the time the form
is completed;
(6) Yes or no to the question “Do you have health
insurance”;
(7) Name of the insurance provider, PCP, or
health care provider;
(8) List of medications being taken by the
patient;
(9) Yes or no to “Do you have any allergies to
medication” and if yes list the medication the patient is allergic to including
any food allergies;
(10) Answer to the question “Do you have a
preferred tobacco cessation product you would like to use”;
(11) Yes or no to the question to “Have you tried
quitting smoking in the past” and if yes describe the attempt;
(12) Answer the question “What best describes how
you have tried to stop smoking in the past” with one of the following:
a. Cold turkey;
b. Tapering or slowly reducing the number of
cigarettes you smoke a day;
c. Medicine:
1. Nicotine replacement (like patches, gum, inhalers, lozenges,
etc.); or
2. Prescription medications (ex. Bupropion
[Zyban, Wellbutrin], Varenicline [Chantrix]_
d. Other;
(13) Answer yes, no, or not sure to the following
background information questions:
a. Are you under 18 years of age;
b. Are you pregnant, nursing, or planning on
getting pregnant or nursing in the next 6 months; and
c. Are you currently using and trying to quit
non-cigarette products (ex. Chewing tobacco, vaping, e-cigarettes, Juul);
(14) Answer yes, no, or not sure to the following
medical history questions:
a. Have you ever had a heart attack, irregular
heart beat or angina, or chest pains in the past two weeks;
b. Do you have stomach ulcers;
c. Do you wear dentures or have TMJ
(temporomandibular joint disease;
d. Do you have a chronic nasal disorder (ex.
Nasal polyps, sinusitis, rhinitis);
e. Do you have a chronic nasal disorder (ex.
Nasal polyps, sinusitis, rhinitis); and
f. Do you have asthma or another chronic lung
disorder (ex. COPD, emphysema, chronic bronchitis;
g. Have you ever had an eating disorder such as
anorexia or bulimia;
h. Have you ever had seizure, convulsion,
significant head trauma, brain surgery, history of stroke , or diagnosis of
epilepsy;
i. Have you ever been diagnosed with chronic
kidney disease;
j. Have you ever been diagnosed with liver
disease;
k. Have you been diagnosed with or treated for
mental health illness in the past 2 ears (ex. Depression, anxiety, bipolar
disorder, schizophrenia;
l. Do you take a monoamine oxidase inhibitor
(MAOI) antidepressant (ex. Selegiline [Emsam, Zelapar], Phenelzine [Nardil],
Isocarboxazid [Marplan], Tranylcypromine [Parnate], Rasagiline [Azilect]);
m. Do you take linexolid
(Zyvox); and
n. Do you use alcohol or have you recently
stopped taking sedatives (ex. Benzodiazepines);
(15) Yes or no to the question “Do you smoke fewer
than 10 cigarettes a day”;
(16) Answer the following questions with not at
all, several days, more than half the days, or nearly every day:
a. Over the last 2 weeks, how often have you
been bothered by any of the following problems:
1. Little interest or pleasure in doing things;
and
2. Feeling down, depressed or hopeless;
(17) Answer the following suicide screening
question with not at all, several days, more than half the days, or nearly
every day:
a. Over the last 2 weeks, how often have you had
thoughts that you would be better off dead, or thoughts of hurting yourself in
some way; and
(18) The patient’s signature and date of signing.
(b)
The “Tobacco Cessation Assessment & Treatment Care Pathway” shall be
the document revised 12/2022 and available on the boards web site, https://www.oplc.nh.gov/board-pharmacy-forms-and-documents.
Source. #13559, eff 4-12-23
PART Ph 2605 STANDARDS OF PRACTICE
Ph 2605.01
Pharmacist Standards of Practice.
(a)
Pharmacists under this chapter shall comply by using the most current “Tobacco Cessation Self-Screening Patient
Intake form” revised 11/2022 and “Tobacco Cessation Assessment and Treatment
Care Pathway” revised 11/2022.
(b)
Pharmacists shall maintain a current copy of
the standing order and make it readily available upon inspection or request by
the board; and
(c)
Pharmacists under this chapter shall properly screen patients for
appropriate therapies or referral and work with the pharmacist’s medical
partners and the New Hampshire department of health and human services to
provide support for patients to improve outcomes.
Source. #13559, eff 4-12-23
Ph 2605.02
Prohibited Practices and Restrictions. A pharmacist who engages in the dispensing of nicotine cessation
therapy shall not:
(a)
Contract with a practitioner to gain financial compensation, or seek
financial benefit through incentive-based programs or any other inducements; or
(b)
Initiate or dispense nicotine cessation therapy in instances where the
“Tobacco Cessation Assessment and Treatment Care Pathway” requires a referral to a practitioner.
Source. #13559, eff 4-12-23
PART Ph 2606
IMMUNITY
Ph 2606.01 Immunity. The board shall not penalize pharmacists under this chapter for following standing orders that contain a
defect if the requirements in Ph 2600 and RSA 318:47-m are satisfied.
Source. #13559, eff 4-12-23
Rule |
|
|
Ph 103.01 |
RSA 318:2 |
|
Ph 104.03 |
RSA 318:5-a, VII; RSA 318:25, II |
|
|
|
|
Ph 201 |
RSA 541-A:16, I(b)-(d); RSA 318 |
|
|
|
|
Ph 301.01 |
RSA 318:5-a, I, III; RSA 318:18 |
|
Ph 301.02 |
RSA 318:5-a, II; RSA 318:18; RSA 318:19 |
|
Ph 301.03 |
RSA 318:5-a, I; RSA 318:10; RSA 318:18 |
|
Ph 301.04 |
RSA 318:5-a, IV; RSA 318:10 |
|
Ph 301.05 |
RSA 318:5-a, IV |
|
Ph 301.06, Ph 301.07 |
RSA 318:10; RSA 318:18, II; RSA 318:29, I |
|
Ph 302.01 |
RSA 318:21 |
|
Ph 302.02 |
RSA 318:21 |
|
Ph 302.03 |
RSA 318:21 |
|
Ph 302.04, Ph 302.05, Ph 302.06 |
RSA 318:21 |
|
Ph 302.07 |
RSA 318:5-a, VII |
|
Ph 302.08, Ph 302.09 |
RSA 318:5-a, IV |
|
Ph 303 |
RSA 318:5-a, I, II, IV-a, V, VII |
|
Ph 303.02 (d), (h), and (j) |
RSA 318:5-a, XIV |
|
Ph 304.01 |
RSA 318:38, I, II, III |
|
Ph 304.02 |
RSA 318:38, III; RSA 318:39 |
|
Ph 305, Ph 306 |
RSA 318-B:23 |
|
Ph 306.01(d) |
RSA 318:5-a, II and IV-a |
|
Ph 306.05(c) |
RSA 318:38, III |
|
Ph 307 |
RSA 318:38, III; RSA 318-B:25 |
|
Ph 308 |
RSA 318:5-a, VII |
|
Ph 309 (moved to Ph 1000) |
|
|
|
|
|
Ph 401.01 |
RSA 318:5-a, I,III, V, VII, and VII-a |
|
Ph 401.02 (a) and (b) |
RSA 318:25 |
|
Ph 401.02(c) and (d) |
RSA 318:5-a, VII and RSA 318:16-b, IV |
|
Ph 401.02(e) |
RSA 318:29-a, VI (b) |
|
Ph 401.03 - Ph 401.05 |
RSA 318:26 |
|
Ph 401.06 - Ph 401.07 |
RSA 318:5-a, II |
|
Ph 401.07 |
|
|
Ph 402.01 - Ph 402.04 |
RSA 318:5-a, VI, VII |
|
Ph 403.01 - Ph 403.02 |
RSA 318:29, I, II, IV, V; RSA 318:5-a,VII-a |
|
Ph 403.03 – Ph 403.13 |
RSA 318:25, III |
|
Ph 404 |
RSA 318:5-a, II, IV-a |
|
Ph 405 |
RSA 318:5-a, II, IV-a |
|
|
|
|
Ph 500 |
RSA 318:5-a, VI |
|
Ph 501.01 |
RSA 318:5-a, VI |
|
|
|
|
Ph 601.01 – Ph 601.04 |
RSA 318:5-a, I, II, III, IV-a, V, VI, and VII; RSA
318:51-b |
|
Ph 601.05 |
RSA 318:5-a, VII |
|
Ph 601.06 – Ph 601.16 |
RSA 318:5-a, I, II, III, IV-a, V, VI, and VII; RSA
318:51-b |
|
Ph 601.06 – Ph 601.10(a)-(c) |
RSA 318:5-a, I, II, III, IV-a, V, VI, and VII; RSA
318:51-b |
|
Ph 601.01 (e) |
RSA 318:5-a, VII |
|
Ph 601.10 |
RSA 318:5-a, II; RSA 318:51-b, II(b), 21 CFR
1301.72(a) |
|
Ph 601.10(d) |
21 CFR 1301.72(a) |
|
Ph 601.10 (e)-(h) |
RSA 318:5-a, II; RSA 318:51-b, II(b) |
|
Ph 601.11 |
RSA 318:51-b, I, II(d) |
|
Ph 601.12(a) |
RSA 318:51-b, I, II(d) |
|
Ph 601.12(b) |
21 CFR 1301.74(h) |
|
Ph 601.13 |
RSA 318:51-b, I, II(b) and (d) |
|
Ph 601.14 |
RSA 318:51-b, I |
|
Ph 601.14 (c)(5) |
RSA 318:51-b, II(d) |
|
Ph 601.15- Ph 601.17 |
RSA 318:5-a, I, II, III, IV-a, V, VI, and VII; RSA
318:51-b |
|
Ph 602 |
RSA 318:51-b |
|
|
|
|
Ph 701.0 - Ph 701.03 |
RSA 318:5-a, IV-a |
|
Ph 702.01 – 702.03 (Formerly Ph 703.01 – 703.03) |
RSA 318:5-a, III, IV-a, IX |
|
Ph 702.04 (Formerly Ph 703.05) |
RSA 318:5-a, II, IV-a |
|
Ph 703.01 (Formerly Ph 704.01) |
RSA 318:5-a, XIV, IV-a |
|
Ph 703.02 |
RSA 318:5-a, XIV, IV-a |
|
Ph 703.03 (Formerly Ph 704.04) |
RSA 318:5-a, II, III, IV-a, XV |
|
Ph 703.04 (Formerly Ph 704.06) |
RSA 318:5-a, II, III, IV-a, XV |
|
Ph 703.05 (Formerly Ph 704.07) |
RSA 318:38, I; RSA 91-A |
|
Ph 703.06 (Formerly Ph 704.08) |
RSA 318:47-c |
|
Ph 703.07 (Formerly Ph 704.09) |
RSA 318:47-c |
|
Ph 703.08 (Formerly Ph 704.14) |
RSA 318:52-a |
|
Ph 703.09 (Formerly Ph 704.15) |
RSA 318-B:9, I, III, IV |
|
Ph 703.10 (Formerly Ph 704.16) |
RSA 318:29, V, (g)(h) |
|
Ph 701.02 and Ph 701.03 |
RSA 318:5-a, IV-a |
|
Ph 704 (Formerly 706) |
RSA 318:5-a, IV-a |
|
Ph 705.01 (Formerly Ph 707.01) |
RSA 318:5-a, IV-a |
|
Ph 705.02 (Formerly Ph 707.02) |
RSA 318:5-a, , II, III, IV-a |
|
Ph 705.02(a) (Formerly Ph 707.02 (a)) |
RSA 318:5-a, III, IV-a |
|
Ph 705.02(b)(1) (Formerly Ph 707.02 (b)(1)) |
RSA 318:5-a, II |
|
Ph 705.02 (b)(7) (Formerly Ph 707.02 (b) (7)) |
RSA 318:5-a, III |
|
Ph 705.03 (Formerly Ph 707.03) |
RSA 318:5-a, IV-a |
|
Ph 705.04 (Formerly Ph 707.04) |
RSA 318-B:17-a, RSA 318:5-a, IV-a |
|
Ph 705.05 and Ph 705.06 (Formerly Ph 707.05 and Ph
707.06) |
RSA 318:5-a, IV-a |
|
Ph 706.01 and Ph 706.02 (formerly Ph 710.01 and Ph
710.02) |
RSA 318:5-a, IV-a, VII; RSA 318:29, IV |
|
|
|
|
Ph 801.01 |
RSA 318:5-a, X (a); RSA 541-A:7 |
|
Ph 802.01 |
RSA 318:5-a, X (a); RSA 541-A:7 |
|
Ph 803.01 |
RSA 318:5-a, X (a); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 803.02 |
RSA 318:5-a, X (a); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 804.01 |
RSA 318:5-a, X (f); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 805.01 |
RSA 318:5-a, X (b); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 805.02 |
RSA 318:5-a, X (b); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 806.01 |
RSA 318:5-a, X (d); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 806.02 |
RSA 318:5-a, X (g); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 807.01 |
RSA 318:5-a, X (b); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 807.02 |
RSA 318:5-a, X(b); RSA 318:15-a |
|
Ph 808.01 |
RSA 318:5-a, X (a); RSA 318:15-a |
|
Ph 808.02 |
RSA 318:5-a, X (a); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 809.01 |
RSA 318:5-a, X (f); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 810.01 |
RSA 318:5-a, X (b); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 810.02 |
RSA 318:5-a, X (f); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 810.03 |
RSA 318:5-a, X (f); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 810.04 |
RSA 318:5-a, X (f); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 811.01 |
RSA 318:5-a, X (d); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 811.02 |
RSA 318:5-a, X (g); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 812.01 |
RSA 318:5-a, X (b); RSA 318:5-a, XI; RSA 318:15-a |
|
Ph 812.02 |
RSA 318:5-a, X(b); RSA 318:15-a |
|
|
|
|
Ph 900 |
RSA 318:5-a; RSA 318:37, II |
|
Ph 901.01 |
RSA 541-A:8 |
|
Ph 902.01 |
RSA 541-A:7; RSA 541-A:8 |
|
Ph 902.02 |
RSA 541-A:7; RSA 541-A:8 |
|
Ph 902.03 |
RSA 541-A:7; RSA 541-A:8 |
|
Ph 902.04 |
RSA 541-A:7; RSA 541-A:8 |
|
Ph 903 – Ph 907 |
RSA 318:37; RSA 318:38 |
|
Ph 903.01 |
RSA 318:5-a, XII & XIII, RSA 318:37; RSA 318:38 |
|
Ph 906.03 intro. and (d) |
RSA 318:5-a, I, IV-a |
|
|
|
|
Ph 1000 |
RSA 318:5-a, I, II, III, V, VII; RSA 318:42, III;
RSA 318:51-a; RSA 318-B:3; RSA 318-B:5 |
|
Ph 1001.01 |
RSA 318:51-a, I |
|
Ph 1002.12 |
RSA 318:51-a, I |
|
Ph 1101.01 |
RSA 541-A:7 |
|
Ph 1102.01 |
RSA 318:1, XXV; RSA 318:5-a, XVII(b) |
|
Ph 1102.02 |
RSA 318:1, XXVI; RSA 318:5-a, XVII(b) |
|
Ph 1102.03 |
RSA 318:1, XXVII; RSA 318:5-a, XVII(b) |
|
Ph 1102.04 |
RSA 541-A:7; RSA 318:5-a, XVII(b) |
|
Ph 1102.05 |
RSA 318:1, III; RSA 318:5-a, XVII(b) |
|
Ph 1103.01 |
RSA 318:5-a, II, XVII(b); RSA 318:16-a, I |
|
Ph 1103.02 |
RSA 318:5-a, XVII (b); RSA 318:16-a, II |
|
Ph 1104.01 |
RSA 318:5-a. II, III |
|
Ph 1105.01 |
RSA 318:5-a, XVII(b); RSA 318:16-a, IV |
|
Ph 1105.02 |
RSA 318:5-a, XVII(b); RSA 318:16-a, IV |
|
Ph 1105.03 |
RSA 318:5-a, XVII(b); RSA 318:16-a, IV |
|
Ph 1105.04 |
RSA 541-A:16, I(b) intro.; RSA 318:5, II; RSA
318:5-a, XVII(b) |
|
|
|
|
Ph 1201 |
RSA 541-A:7; RSA 541-A:8 |
|
Ph 1202 |
RSA 541-A:7; RSA 541-A:8 |
|
Ph 1203 |
RSA 318:5-a, XIII |
|
|
|
|
Ph 1301.01 |
RSA 541-A:8; RSA 318:5-a |
|
Ph 1301.02 |
RSA 541-A:8; RSA 318:5-a, IV-a |
|
Ph 1302.01, Ph 1302.02, and Ph 1302.04 |
RSA 541-A:7; RSA 541-A:8; RSA 541-A:16, I(b); RSA
318:5-a |
|
Ph 1303.01 |
RSA 318:16-b |
|
Ph 1303.02 |
RSA 541-A:16, I(b); RSA 318:16-b, IV |
|
Ph 1304 |
RSA 318:16-b; RSA 318:16-f |
|
|
|
|
Ph 1601- Ph 1608 |
RSA 318:5-a XI-a; 318:5-a XI-b; and 318:15-b |
|
Ph 1602.01 |
RSA 318:15-b; RSA 541-A:7 |
|
Ph 1603.01 |
RSA 318:5-a, XI-a (a), (b); RSA 318:15-b |
|
Ph 1604.01 |
RSA 318:5-a, XI-a (a); RSA 318:5-b; RSA 318:15-b |
|
Ph 1605.01 |
RSA 318:5-a, XI-a (b), (c); RSA 318:15-b |
|
Ph 1606.01 |
RSA 318:5-a, XI-a (b); RSA 318:15-b |
|
Ph 1606.02 |
RSA 318:5-a, XI-a (b); RSA 318:15-b |
|
Ph 1607.01 |
RSA 318:5-a, XI-a, (d); RSA 318:15-b |
|
Ph 1608.01 |
RSA 318:5-a, XI-a, (f); RSA 318:15-b |
|
Ph 1608.02 |
RSA 318:5-a, XI-a, (f); RSA 318:15-b |
|
Ph 1608.03 |
RSA 318:5-a, XI-a, (f); RSA 318:15-b |
|
|
|
|
Ph 1801 |
RSA 318:5-a, IV-a, X, XIV; RSA 318:15-a and c |
|
Ph 1802 |
RSA 318:1, XXXIII; RSA 318:5-a, IV-a, X, XIV; RSA 318:15-a and c |
|
Ph 1803 |
RSA 318:5-a, II, IV; RSA 318:5-a, X(a) |
|
Ph 1804 |
RSA 318:5-a, X(b); RSA 318:15-a |
|
Ph 1805 |
RSA 318:5-a, X(d) |
|
Ph 1806 |
RSA 318:5-a, X(f) |
|
Ph 1807 |
RSA 318:5-a, XI(c) |
|
Ph 1808 |
RSA 318:5-a, XI-c(b) |
|
Ph 1809 |
RSA 318:16-b |
|
|
|
|
Ph 2001 |
RSA 541-A:7; RSA 318:51-c; RSA 318:51-d; RSA
318:51-d |
|
Ph 2002 |
RSA 541-A:7; RSA 318:1 |
|
Ph 2003 |
RSA 318:51-c; RSA 318:51-d; RSA 318:51-e |
|
Ph 2004 |
RSA 318:51-c, V, VI; RSA 318:51-e, IX |
|
Ph 2005 |
RSA 318:51-c, I; RSA 318:51-e, I-IV, IX |
|
Ph 2006 |
RSA 318:51-d; RSA 318:51-e, VI - VIII |
|
Ph 2007 |
RSA 318:51-d ; RSA 318:51-e, VII |
|
Ph 2008 |
RSA 318:51-d; RSA 318:51, e, IX |
|
|
|
|
Ph 2101.01 |
RSA 318:5-a, IX; RSA 541-A:16, I(b) |
|
Ph 2102.01 |
RSA 318:5-a, IX; RSA 318:8-a; RSA 318:9-a; RSA
318-B:25; RSA 541-A:16, I(b) |
|
Ph 2102.02 |
RSA 318:5-a, IX; RSA 318:8-a; RSA 318:9-a; RSA
318-B:25; RSA 541-A:16, I(b) |
|
Ph 2103.01 |
RSA 318:5-a, IX; RSA 541-A:16, I(b) |
|
Ph 2104.01 |
RSA 318:5-a, IX; RSA 541-A:16, I(b); RSA 318-B:25 |
|
Ph 2104.02 |
RSA 318:5-a, IX; RSA 318:8-a;RSA 318:9-a; RSA
318-B:25 |
|
Ph 2105.01 |
RSA 318:5-a, IX; RSA 541-A:16, I(b); RSA 318-B:25 |
|
|
|
|
Ph 2201.01 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a; RSA 318:42 |
|
Ph 2202.01 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a;
RSA 318:42 |
|
Ph 2202.02 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a;
RSA 318:42 |
|
Ph 2203.01 |
RSA 318:30; RSA 318-B:24; RSA 318:47-h; RSA 318:8-a;
RSA 318:14-a; RSA 318:42 |
|
Ph 2204.01 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a;
RSA 318:42 |
|
Ph 2205.01 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a;
RSA 318:42 |
|
Ph 2205.02 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a;
RSA 318:42 |
|
Ph 2205.03 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a;
RSA 318:42 |
|
Ph 2206.01 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a; RSA 318:42 |
|
Ph 2206.02 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a;
RSA 318:42 |
|
Ph 2206.03 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a;
RSA 318:42 |
|
Ph 2207.01 |
RSA 318:30; RSA 318-B:24; RSA 318:29; RSA 318-B:26; RSA 318-B:36; RSA 318:8-a; RSA 318:14-a; RSA 318:42 |
|
Ph 2207.02 |
RSA 318:30; RSA 318-B:24; RSA 318:29; RSA 318-B:26; RSA 318-B:36; RSA 318:8-a; RSA 318:14-a; RSA 318:42 |
|
Ph 2201.01 |
RSA 318:30; RSA 318-B:24; RSA 318:8-a; RSA 318:14-a;
RSA 318:42 |
|
Ph 2301.01 |
RSA 318:5-a, XII; RSA 318:5-a, XIII |
|
Ph 2301.02 |
RSA 318:5-a, IV-a |
|
Ph 2301.03 |
RSA 318:5-a, XIII |
|
Ph 2301.04 |
RSA 318:5-a, XII |
|
Ph 2301.05 |
RSA 318:5-a, XII |
|
Ph 2301.06 |
RSA 318:5-a, XII |
|
Ph 2301.07 |
RSA 318:5-a, XIII |
|
Ph 2301.08 |
RSA 318:5-a, XII |
|
Ph 2301.09 |
RSA 318:5-a, XII |
|
Ph 2400 |
RSA 318:5-a, I, V, and IX; RSA 318:47-I |
|
Ph 2500 |
RSA 318:1, XXII; RSA 318:5-a, XII; RSA 318:42, XV; RSA 541-A:16, I(b) |
|
|
|
|
Ph 2600 |
RSA 318:5-a, XVII |
Appendix II
Incorporation by Reference Information
|
Rule |
Title |
Obtain at: |
|
Ph 2402.01(i)(1) |
U.S. Medical Eligibility Criteria (MEC) for
Contraceptive Use (Revised July 29, 2016) |
Center for Disease Control and Prevention Online: https://www.cdc.gov/mmwr/volumes/65/rr/rr6503a1.htm?s_cid=rr6503a1_w Cost:
None Any questions or information requests can be
directed to the New Hampshire Board of Pharmacy by calling 603-271-2152 |
|
Ph 2402.01(i)(2) |
U.S. Selected
Practice Recommendations (SPR) for Contraceptive Use (Revised July 29,
2016 |
Center for Disease
Control and Prevention Online: https://www.cdc.gov/mmwr/volumes/65/rr/rr6504a1.htm Cost: None Any questions or
information requests can be directed to the Office of Licensed Allied Health
Professionals by calling 603-271-2152 |