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, 1650 University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, (505)
841-9102.
[02-15-1889...02-15-96;
16.19.18.1 NMAC - Rn, 16 NMAC 19.18.1, 03-30-02]
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.
[02-15-96;
16.19.18.2 NMAC - Rn, 16 NMAC 19.18.2, 03-30-02]
16.19.18.3 STATUTORY AUTHORITY: Section 61-11-6.A.(1) 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) directs the Board to provide for the registration and annual
renewal of licenses of pharmacists. Pursuant to 61-11-6.A.(6), 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.
[02-15-96;
A, 05-30-98; 16.19.18.3 NMAC - Rn, 16 NMAC 19.18.3, 03-30-02]
16.19.18.4 DURATION: Permanent.
[02-15-96;
16.19.18.4 NMAC - Rn, 16 NMAC 19.18.4, 03-30-02]
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 2-15-96.
[02-15-96;
A, 05-30-98; 16.19.18.5 NMAC - Rn, 16 NMAC 19.18.5, 03-30-02]
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.
[02-15-96;
16.19.18.6 NMAC - Rn, 16 NMAC 19.18.6, 03-30-02]
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., 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;
(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 hours 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;
(v) radiopharmaceutical
chemistry; and
(c) 50 hours in the clinical use of
radiopharmaceuticals.
(3) "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) "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) "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) "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) "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.
[05-29-94,
05-30-98; 16.19.18.7 NMAC - Rn, 16 NMAC 19.18.7, 03-30-02]
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.
[05-20-94;
16.19.18.8 NMAC - Rn, 16 NMAC 19.18.8, 03-30-02]
16.19.18.9 REQUIREMENTS FOR OPERATION OF A
NUCLEAR PHARMACY:
A. A nuclear pharmacy shall meet the requirements of 16 NMAC
19.6 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, 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 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 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;
[05-20-94;
16.19.18.9 NMAC - Rn, 16 NMAC 19.18.9, 03-30-02]
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, 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.
[05-20-94;
16.19.18.10 NMAC - Rn, 16 NMAC 19.18.10, 03-30-02]
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, 4-20-94.
History
of Repealed Material: [RESERVED]
Other
History: 16 NMAC 19.18, Pharmacists -
Nuclear Pharmacy, filed 02-02-96, reformatted and renumbered to 16.19.18 NMAC,
Nuclear Pharmacy, effective 03-30-2002.