Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.500 - Nuclear Pharmacy-Minimum Standards for Operation

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: The board is amending all sections of the
				  current rule to update, modernize, and clarify rule
				  requirements.
PURPOSE: This rule defines minimum standards for the
				  operation of nuclear pharmacies and the preparation, labeling, dispensing,
				  delivering, compounding, and repackaging of radio pharmaceuticals pursuant to a
				  prescription drug or medication order. This regulation is intended to
				  supplement other regulations of the Board of Pharmacy, as well as those of
				  other state and/or federal agencies.
(1) Definitions.
(A) "Agreement state" means any state that
				has entered into an agreement under subsection 274b of the Atomic Energy Act of
				1954, as amended, in which the United States Nuclear Regulatory Commission has
				relinquished to such states the majority of its regulatory authority over
				source material, by product, and special nuclear material in quantities not
				sufficient to form a critical mass.
(B) "Authentication of product history" means
				identifying the purchasing source, the ultimate fate, and any intermediate
				handling of any component of a radio pharmaceutical or other drug.
(C) "Authorized address or location" means
				the building or buildings that are identified on the license and where
				by-product material may be received, prepared, used, or stored as defined by
				10 CFR
				35.2 or a temporary job site for providing
				mobile nuclear medicine services in accordance with
				10 CFR
				35.80.
(D) "Authorized nuclear pharmacist" (ANP)
				means a pharmacist who holds a current license issued by the board and who is
				either certified as a nuclear pharmacist by the Board of Pharmacy Specialties,
				has attained status as an authorized nuclear pharmacist, or an authorized user
				of radioactive material, as specified by the Nuclear Regulatory Commission or
				Agreement State regulations, including, but not limited to,
				10
				CFR 35.55,
				35.57
				and
				35.59.
(E) "Contingency prescription drug order"
				means a radioactive prescription drug order issued for contingency material for
				a diagnostic purpose.
(F)
				"Controlled access area" means an area outside of the restricted area but
				inside the pharmacy, access to which will be limited to the public.
(G) "NRC" means the United States Nuclear
				Regulatory Commission.
(H) "Nuclear
				pharmacy" means the location that provides radio pharmaceutical services and
				where radio pharmaceuticals and chemicals within the classification of legend
				drugs, are prepared, compounded, repackaged, dispensed, stored, sold, or used
				for nuclear medicine procedures. The term "nuclear pharmacy" does not include
				the nuclear medicine facilities of hospitals or clinics where radio
				pharmaceuticals are compounded or dispensed to patients under the supervision
				of a licensed physician, authorized by the Nuclear Regulatory Commission or
				Agreement State regulations. Nothing in this rule shall be construed as
				requiring a licensed clinical laboratory, which is also licensed by the Nuclear
				Regulatory Commission or Agreement State to handle radioactive materials, to
				obtain the services of a nuclear pharmacist, or to have a pharmacy permit,
				unless the laboratory is engaged in the commercial sale or resale of
				radio-pharmaceuticals.
(I) "Nuclear
				pharmacy technician" means a person who has successfully completed a nuclear
				pharmacy technician training program provided by an accredited college program
				or meets the American Pharmacist's Association's (APhA) Guidelines for Nuclear
				Pharmacy Technician Training Program or an equivalent company sponsored program
				that meets APhA guidelines for nuclear pharmacy technician training.
(J) "Practice of nuclear pharmacy" means a
				patient-oriented service that embodies the scientific knowledge and
				professional judgment required to improve and promote health through the
				assurance of the safe and efficacious use of radio pharmaceuticals and other
				drugs.
(K) "Preparing of radio
				pharmaceuticals" means the addition of a radioactive substance, or the use of a
				radioactive substance in preparation of a single-dose or multiple-dose
				medication, pursuant to the prescription drug order/contingency prescription
				drug order. Such preparing of radiopharmaceuticals includes, but is not limited
				to, loading and eluting of radionuclide generators, using manufactured reagent
				kits to prepare radiopharmaceuticals, preparing reagent kits, aliquoting
				reagents, and conducting quality control tests of
				radiopharmaceuticals.
(L)
				"Prescription drug order" means a prescription drug order issued for a specific
				patient for a diagnostic or therapeutic purpose.
(M) "Quality control testing" means, but is
				not limited to, the performance of appropriate chemical, biological, physical,
				radiochemical, and radionuclidic purity tests on radiopharmaceuticals and the
				interpretation of the resulting data to determine their suitability for use in
				humans and animals.
(N) "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. handling of any component of a
				radiopharmaceutical or other drug.
(O) "Radiopharmaceutical" means any drug
				which exhibits spontaneous disintegration of unstable nuclei with the emission
				of nuclear particles or photons 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.
(P)
				"Radiopharmaceutical services" means, but not limited to, the procurement,
				storage, handling, compounding, preparation, repackaging, labeling, quality
				control testing, dispensing, delivery, transfer, record-keeping, and disposal
				of radiochemicals, radiopharmaceuticals, and ancillary drugs; the participation
				in radiopharmaceutical selection and radiopharmaceutical utilization review,
				and also includes quality assurance procedures, radiological healthcare
				activities, any consulting activities associated with the use of
				radiopharmaceuticals, and any other activities required for provision of
				radiopharmaceutical care; the responsibility for advising, where necessary or
				where regulated, of therapeutic values, hazards and use of
				radiopharmaceuticals; and the offering or performing of those acts, services,
				operations, or transactions necessary in the conduct, operation management, and
				control of a nuclear pharmacy.
(Q)
				"Restricted area" means an area within the pharmacy that is secured from the
				Controlled Access Area and to which access is limited for the purpose of
				protecting individuals against exposure to radiation and radioactive
				materials.
(R) "Therapeutic
				prescription drug order" means a radioactive prescription drug issued for a
				specific patient for a therapeutic purpose.
(S) "Unit dose container" (e.g., shield or
				"pig") means a container designed to hold doses of radiopharmaceutical agents
				and to prevent or minimize/reduce the emission of radiation or radioactive
				materials by using appropriate shielding materials.