Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:215 - Nuclear pharmacy services

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapter 315
NECESSITY, FUNCTION, AND CONFORMITY: The Kentucky Board of
				Pharmacy shall be responsible for imposing minimum standards in all settings
				where drug products are dispensed and to ensure the safety of all drug products
				provided to the citizens of the Commonwealth. This administrative regulation
				applies to pharmacies as defined in
				KRS
				315.010. The requirement of these
				administrative regulations are in addition to, and not in substitution of,
				other applicable administrative regulations promulgated by the Cabinet for
				Human Resources for radioactive materials and applicable administrative
				regulations promulgated by the Kentucky Board of Pharmacy.
Section 1. Definitions.
(1) "Nuclear pharmacy" means a pharmacy
			 providing radiopharmaceutical services.
(2) "Radiopharmaceutical services" means
			 those acts, services, operations and transactions necessary in the conduct,
			 operation, management and control of a nuclear pharmacy, including, for
			 example:
(a) The compounding, dispensing,
			 labeling and delivery of radiopharmaceuticals;
(b) The participation in radiopharmaceutical
			 utilization reviews; and
(c) The
			 proper and safe storage and distribution of radiopharmaceuticals.
(3) "Radiopharmaceutical" means
			 any substance defined as a drug in Section 201(g)(1) of the Federal Food, Drug
			 and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei
			 with the emission of nuclear particles or photons and includes any of those
			 drugs intended to be made radioactive. This includes nonradioactive reagent
			 kits and nuclide generators which are intended to be used in the preparation of
			 any such substance, but does not include drugs which are carbon-containing
			 compounds or potassium-containing compounds or potassium-containing salts which
			 contain trace quantities of naturally occurring radionuclides.
(4) "Radiopharmaceutical quality assurance"
			 means the performance of appropriate chemical, biological and physical tests on
			 radiopharmaceuticals and the interpretation of the resulting data to determine
			 their suitability for use in humans and animals, and it shall include, for
			 example, internal test assessment, authentication of product history and the
			 keeping of proper records.
(5)
			 "Internal test assessment" means conducting those tests necessary to insure the
			 integrity of the test.
(6)
			 "Authentication of product history" means identifying the purchase source, the
			 ultimate use or disposition and any intermediate handling of any components of
			 a radiopharmaceutical.
(7)
			 "Authorized practitioner" means a practitioner duly authorized by applicable
			 federal and state law to possess, use and administer radiopharmaceuticals. This
			 person shall be named on a radioactive materials license issued by the
			 Radiation Control Branch of the Cabinet for Human Resources.
(8) "Designated agent" means an individual
			 who shall be under the direct supervision of an authorized practitioner and who
			 shall be authorized to communicate that practitioner's instructions to a
			 nuclear pharmacy.
(9) "Nuclear
			 pharmacist" means a pharmacist licensed to practice in the Commonwealth of
			 Kentucky and who meets minimal standards of training and experience in the
			 handling of radioactive materials in accordance with the requirements of the
			 Radiation Control Branch of the Cabinet for Human Resources.
(10) "Direct supervision" means that the
			 supervising nuclear pharmacist shall be physically present in the general area
			 or location where the supportive personnel are performing supportive duties and
			 shall conduct in-process and final checks.