N.M. Admin. Code § 16.19.18.7

Current through Register Vol. 35, No. 20, October 22, 2024

Section 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.

N.M. Admin. Code § 16.19.18.7

05-29-94, 05-30-98; 16.19.18.7 NMAC - Rn, 16 NMAC 19.18.7, 03-30-02, Amended by New Mexico Register, Volume XXX, Issue 23, December 17, 2019, eff. 12/17/2019