New Mexico Register / Volume XXXVI,
Issue 22 / November 18, 2025
This is an
amendment to 16.19.18 NMAC, Section 1, 7 and 9 effective 11/18/2025
16.19.18.1 ISSUING AGENCY: [Regulation and Licensing Department -]
Board of Pharmacy.
[2/15/1989...2/15/1996;
16.19.18.1 NMAC - Rn, 16 NMAC 19.18.1, 3/30/2002; A, 12/17/2019; A, 11/18/2025]
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 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)] (1) Must
have successfully completed the requirements of Subparagraphs (a) and (b) of
this Paragraph.
(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.
(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.
[(3)] (2) 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]
Paragraph (1) [ and (2)] of Subsection C of 16.19.18.7 NMAC.
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.
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.
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.
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.
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.
[5/29/1994,
5/30/1998; 16.19.18.7 NMAC - Rn, 16 NMAC 19.18.7, 3/30/2002; A, 12/17/2019; A,
11/18/2025]
16.19.18.9 REQUIREMENTS FOR OPERATION OF A
NUCLEAR PHARMACY:
A. A nuclear
pharmacy shall meet the requirements of 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 16.19.6.10 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. A nuclear
pharmacy shall have the minimum equipment, accessories and space as necessary
for the manufacture of radiopharmaceuticals as specified by the Federal Atomic
Energy Commission, the Federal Food and Drug Administration, the U.S. Public
Health Service regulations and the New Mexico Radiation Protection Act
administered by the Environmental Improvement Agency. [The following minimum equipment
requirements, as appropriate for the scope of nuclear pharmacy services
provided, are in addition to those contained in 16.19.6.11 NMAC:
(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; A, 11/18/2025]