TITLE
16 OCCUPATIONAL AND
PROFESSIONAL LICENSING
CHAPTER
19 PHARMACISTS
PART
18 NUCLEAR PHARMACY
16.19.18.1 ISSUING AGENCY: Regulation and Licensing Department - Board
of Pharmacy.
[2/15/1889...2/15/1996;
16.19.18.1 NMAC - Rn, 16 NMAC 19.18.1, 3/30/2002; A, 12/17/2019]
16.19.18.2 SCOPE: All individuals and entities that
provide radiopharmaceutical products or services or engage in the practice of
nuclear pharmacy, including owners of nuclear pharmacies.
[2/15/1996;
16.19.18.2 NMAC - Rn, 16 NMAC 19.18.2, 3/30/2002]
16.19.18.3 STATUTORY AUTHORITY: 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. 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 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]
16.19.18.4 DURATION: Permanent.
[2/15/1996;
16.19.18.4 NMAC - Rn, 16 NMAC 19.18.4, 3/30/2002]
16.19.18.5 EFFECTIVE DATE: February 15, 1996 unless a different date is
cited at the end of a Section or Paragraph. This Part reformatted for inclusion into the
New Mexico Administrative Code (NMAC) effective 2/15/1996.
[2/15/1996;
A, 5/30/1998; 16.19.18.5 NMAC - Rn, 16 NMAC 19.18.5, 3/30/2002]
16.19.18.6 OBJECTIVE: The objective of Part 18 of Chapter
19 is to recognize and provide for the specialization of nuclear pharmacy and
to protect the public health and welfare of New Mexico citizens by establishing
standards for the practice.
[2/15/1996;
16.19.18.6 NMAC - Rn, 16 NMAC 19.18.6, 3/30/2002]
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) 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) 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.
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]
16.19.18.8 LICENSING REQUIREMENTS FOR A
NUCLEAR PHARMACY:
A. The licensing
provisions contained in this section are in addition to, and not a substitute
for, general licensing requirements for all pharmacies in New Mexico.
B. Any pharmacy
that will provide radiopharmaceutical services must obtain a nuclear pharmacy
license from the Board.
C. A nuclear
pharmacy shall employ one or more qualified nuclear pharmacists. The application for a nuclear pharmacy license
must include documentation that all pharmacists who provide radiopharmaceutical
services in the nuclear pharmacy meet the criteria specified for a qualified
nuclear pharmacist.
[5/20/1994;
16.19.18.8 NMAC - Rn, 16 NMAC 19.18.8, 3/30/2002]
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. 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]
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 16.19.6 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 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.
[5/20/1994;
16.19.18.10 NMAC - Rn, 16 NMAC 19.18.10, 3/30/2002; A, 12/17/2019]
HISTORY OF 16.19.18 NMAC:
Pre-NMAC History: The material in this part was derived from
that previously filed with the State Records Center and Archives:
Regulation
No. 18, Nuclear Pharmacy, 4/20/1994.
History of Repealed Material: [RESERVED]
Other History:
16
NMAC 19.18, Pharmacists - Nuclear Pharmacy, filed 2/2/1996, reformatted and
renumbered to 16.19.18 NMAC, Nuclear Pharmacy, effective 3/30/2002.