New Mexico Register / Volume XXX, Issue 23 / December 17, 2019
This
is an amendment to 16.19.18 NMAC, Sections
1, 3, 7, 9, and 10 effective 12/17/2019
16.19.18.1 ISSUING AGENCY: Regulation and Licensing Department - Board
of Pharmacy[, 1650 University Blvd, NE - Ste. 400B, Albuquerque, NM 87102,
(505) 841-9102].
[2/15/1889...2/15/1996;
16.19.18.1 NMAC - Rn, 16 NMAC 19.18.1, 3/30/2002; A, 12/17/2019]
16.19.18.3 STATUTORY AUTHORITY: [Section
61-11-6.A.(1) NMSA 1978] Paragraph
(1) of Subsection (A) of Section 61-11-6 NMSA 1978 authorizes the
Board of Pharmacy to adopt, regularly review and revise rules and regulations
necessary to carry out the provisions of the Pharmacy Act. [Section 61-11-6.A.(3)] Paragraph (3) of Subsection (A) of Section
61-11-6 NMSA 1978 directs the Board to provide for the registration
and annual renewal of licenses of pharmacists.
Pursuant to [61-11-6.A.(6)] Paragraph (6) of Subsection (A) of Section 61-11-6 NMSA 1978,
the Board is authorized to provide for the licensing of retail pharmacies,
nonresident pharmacies and wholesale drug distributors and to provide for the
inspection of their facilities and activities.
[2/15/1996;
A, 5/30/1998; 16.19.18.3 NMAC - Rn, 16 NMAC 19.18.3, 3/30/2002; A, 12/17/2019]
16.19.18.7 DEFINITIONS:
A. The "Practice of Nuclear Pharmacy"
means a patient-oriented service that embodies the scientific knowledge and
professional judgement required to improve and promote health through the
assurance of the same and efficacious use of radiopharmaceuticals and other
drugs.
B. "Nuclear Pharmacy" means a
pharmacy which provides radiopharmaceutical services, and shall be licensed by
the Board as a wholesaler [and/]or retail pharmacy.
C. "Qualified Nuclear Pharmacist"
means a pharmacist currently licensed by the Board who meets either of the
following criteria:
(1) Must
be currently certified as a Nuclear Pharmacist by the Board of Pharmaceutical
Specialties; or
(2) Must
have successfully completed the requirements of [Paragraph 7.C.2.a.,] Subparagraphs
(a) and (b) of this Paragraph. [and meet a
minimum of 250 contact hours of didactic instruction in nuclear pharmacy and
the safe handling and use of radioactive materials from a nationally-accredited
college of pharmacy or other training program sponsored by an ACPE-accredited
provider of continuing pharmaceutical education, with the minimum 250 contact
hours apportioned according to 7.C.2.b. and 7.C.2.c:]
(a) Must
have attained a minimum of 500 contact hours of experiential training in nuclear
pharmacy under the supervision of a qualified nuclear pharmacist in, but not
limited to, the following areas:
(i) procurement
of radioactive materials;
(ii) compounding
of radiopharmaceuticals;
(iii) maintenance
of a quality assurance program;
(iv) dispensing
of radiopharmaceuticals;
(v) distribution
of radiopharmaceuticals;
(vi) implementation
of basic health and safety practices and procedures; and
(vii) provision
of information and consultation related to the practice of nuclear pharmacy and
the use of radiopharmaceuticals.
[(viii) monitoring of outcomes in patients who receive
radiopharmaceuticals and related ancillary medications;
(ix) research
and development of radiopharmaceuticals].
(b) 200
contact hours of didactic instruction in nuclear pharmacy and the safe
handling and use of radioactive materials, from a nationally-accredited college
of pharmacy or other training program sponsored by an ACPE-accredited provider
of continuing pharmaceutical education, in the following five areas:
(i) radiation
physics and instrumentation;
(ii) radiation
protection;
(iii) mathematics
pertaining to the use and measurement of radioactivity;
(iv) radiation
biology; and
(v) radiopharmaceutical
chemistry. [and
(c) 50
hours in the clinical use of radiopharmaceuticals].
(3) Any pharmacist who has been legally listed on a
radioactive material license for a nuclear pharmacy in the State of New Mexico
for at least six months prior to the 1994 effective date of these regulations,
is exempt from Paragraphs (1) and (2) of Subsection C of 16.19.18.7 NMAC.
[(3)] D. "Radiopharmaceutical Services"
means the procurement, storage, handling, compounding, labeling, quality
control testing, dispensing, distribution, transfer, record keeping and
disposal of radiochemicals, radiopharmaceuticals and ancillary drugs, and also
includes quality assurance procedures, radiological health activities, any
consulting activities associated with the use of radiopharmaceuticals, and any
other activities required for provision of pharmaceutical care.
[(4)] E. "Quality Control Testing"
means the performance of appropriate 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.
[(5)] F. "Quality Assurance Procedures"
means all activities necessary to assure the quality of the process used to
provide radiopharmaceutical services, including authentication of product
history and maintenance of all records as required by pertinent regulatory
agencies.
[(6)] G. "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.
[(7)] H. "Radiopharmaceutical" means
any drug which exhibits spontaneous disintegration of unstable nuclei with the
emission of nuclear particles or protons and 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
'radiopharmaceutical' also includes any biological product which is labeled
with a radionuclide or intended solely to be labeled with a radionuclide.
[D. Any
pharmacist who has been legally listed on a radioactive material license for a
nuclear pharmacy in the State of New Mexico for at least six months prior to
the effective date of these regulations, is exempt from Paragraphs 7.C.1 and
7.C.2.]
[5/29/1994,
5/30/1998; 16.19.18.7 NMAC - Rn, 16 NMAC 19.18.7, 3/30/2002; A, 12/17/2019]
16.19.18.9 REQUIREMENTS FOR OPERATION OF A
NUCLEAR PHARMACY:
A. A nuclear
pharmacy shall meet the requirements of [16 NMAC 19.6] 16.19.6 NMAC
of the Board, except as provided for in this section.
B. A qualified
nuclear pharmacist shall be in personal attendance when the nuclear pharmacy is
open for business.
C. A nuclear
pharmacy shall meet minimum space requirements established for all pharmacies
in the state (see [16 nmac 19.6.10] 16.19.6.10 NMAC, with the
exception that the space may be interrupted).
D. The nuclear
pharmacy shall maintain records of procurement, inventory and disposition of
all radioactive drugs and other radioactive materials.
E. A nuclear
pharmacy shall have a current copy (paper or electronic) of city, state,
and federal regulations governing the safe storage, handling, use, dispensing,
transport and disposal of radiopharmaceuticals.
F. The following
minimum equipment requirements [for a nuclear pharmacy are in lieu of], as
appropriate for the scope of nuclear pharmacy services provided, are in
addition to those contained in 16.19.6.11[.A]
NMAC [Paragraphs
11.A.6-11.A.9; 11.A.12-11.A.14; 11.A.18; 11.A.20 and 11.1.21 (the remainder of
Sub-Section 11.A remains in force)]:
(1) Radionuclide
Dose Calibrator;
(2) Refrigerator;
(3) Single
or multiple channel scintillation counter with well-type NaI(T1) or Ge(Li)
detector;
(4) Radiochemical
fume hood and filter system;
(5) Area
rate meter;
(6) At
least two (2) GM survey meters;
(7) Microscope
and hemacytometer;
(8) Laminar
air flow hood and/or biologic safety cabinet;
(9) Syringe
and vial radiation shields;
(10) Lead-shielded
drawing station;
(11) Decontamination
supplies;
(12) Other
equipment as needed for radiation safety to workers and the public; or for performance
of quality control/quality assurance specified by standards of practice for the
individual setting and the products involved.
G. A nuclear
pharmacy shall operate in conformance with the United States Pharmacopeia General
Chapters: <825> Radiopharmaceuticals
– Preparation, Compounding, Dispensing, and Repackaging, and all other applicable chapters numbered
1000 or less.
[5/20/1994;
16.19.18.9 NMAC - Rn, 16 NMAC 19.18.9, 3/30/2002; A, 12/17/2019]
16.19.18.10 REQUIREMENTS FOR PROVISION OF RADIOPHARMACEUTICAL
SERVICES:
A. Medications
shall be dispensed from a nuclear pharmacy in accordance with the requirements
contained in [16 NMAC 19.6] 16.19.6 NMAC, except as provided for
in this section.
B. A
radiopharmaceutical shall be dispensed only to a licensed practitioner
authorized by the Nuclear Regulatory Commission or an equivalent agreement
state agency to possess, use and administer such drug. A radiopharmaceutical shall be dispensed only
upon receipt of a prescription 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.
C. In addition to
other labeling requirements of the Board for nonradioactive drugs, the outer
container shield of a radiopharmaceutical to be dispensed or transferred shall
also be labeled with the following information:
(1) the
standard radiation symbol;
(2) the
words "Caution -- Radioactive Materials";
(3) the
radionuclide;
(4) the
chemical form;
(5) the
amount of radioactivity and the calibration date and time;
(6) the
expiration date and time;
(7) if
a liquid, the volume;
(8) if
a solid, the number of dosage units or weight;
(9) if
a gas, the number of ampules or vials;
(10) the
name of the patient (required only for radiolabeled blood components and all
radiopharmaceuticals intended for therapeutic use).
D. The inner
container (e.g., syringe, vial, etc.) used to dispense or transfer a
radiopharmaceutical shall be labeled with the following information:
(1) the
standard radiation symbol;
(2) the
prescription or lot number;
(3) the
name of the radiopharmaceutical;
(4) the
name of the patient (required only for radiolabeled blood components and all radiopharmaceuticals
intended for therapeutic use).
E. A licensed
nuclear pharmacy, upon receiving a verbal prescription for a
radiopharmaceutical, shall immediately have the prescription reduced to writing
or recorded in a data processing system.
The writing [and/] or record shall contain at least the following
information, in addition to other requirements of the Board:
(1) the
name of the institution represented;
(2) the
date of the prescription;
(3) the
name and dose of the radiopharmaceutical;
(4) the
name of the procedure;
(5) the
requested date/time of calibration (tentative date/time of administration) of
the prescribed radiopharmaceutical;
(6) the
name of the patient (required for radiolabeled blood components and all
radiopharmaceuticals intended for therapeutic use.);
(7) any
specific instructions, if required.
F. Whenever a
radiopharmaceutical is dispensed under the authority of an Investigational New
Drug Application (INDA), the nuclear pharmacy records shall include an investigator's
protocol for the preparation of the radiopharmaceutical, a copy of the
Institutional Review Board approval form (or letter), and a letter from the
manufacturer (sponsor) indicating that the physician requesting the radiopharmaceutical is a qualified
investigator.
[G. Pharmacists
practicing at a facility licensed under 16 NMAC 19.18 are exempt from
16.19.4.22.5 NMAC through 16.19.4.22.7 NMAC.]
[5/20/1994;
16.19.18.10 NMAC - Rn, 16 NMAC 19.18.10, 3/30/2002; A, 12/17/2019]