W. Va. Code R. § 15-1-13

Current through Register Vol. XLI, No. 24, June 14, 2024

Section 15-1-13 - Licensure and Control of Nuclear Pharmacies

13.1. General Requirements.

13.1.1. A pharmacy providing radiopharmaceutical services, and compounding or mixing prescription orders for radiopharmaceuticals shall obtain a Nuclear Pharmacy registration from the Board. The license will be issued after satisfactory inspection of the completed facilities. The license will be issued only when the pharmacist-in-charge is a qualified nuclear pharmacist and the pharmacy has been approved by the appropriate federal agency.

13.1.2. Pharmacies providing regular pharmacist care in addition to radiopharmaceutical services shall comply with all sections of this rule applicable to pharmacies in general.

13.2. Space.

13.2.1. The nuclear pharmacy area shall be separate from all other pharmacy areas for non-radioactive drugs and shall be secured from unauthorized personnel.

13.2.2. A pharmacy handling radiopharmaceuticals shall provide a radioactive storage and product decay area which meets the requirements of the appropriate federal agency and the 2023 United States Pharmacopeia (USP) Chapter 825 Radiopharmaceuticals.

13.3. Dispensing and labeling.

13.3.1. A prescription order for a radiopharmaceutical shall be dispensed in a package that is properly labeled. A pharmacy may furnish radiopharmaceuticals only to practitioners for administration to patients and for the occasional transfer to another pharmacist.

13.3.2. In addition to any label requirements of the Board for nonradioactive drugs, the immediate outside container of a radiopharmaceutical to be dispensed shall also be labeled with:

13.3.2.a. the standard radiation symbol;

13.3.2.b. The words "CAUTION-Radioactive Material";

13.3.2.c. the name of the radio nucleotide;

13.3.2.d. the chemical form;

13.3.2.e. The amount of radioactive material contained in millicuries or microcuries;

13.3.2.f. The volume in milliliters, if the material is a liquid;

13.3.2.g. The requested calibration time for the amount of radioactivity contained; and

13.3.2.h. The practitioner's name and the assigned lot number.

13.3.3. The immediate inner container shall be labeled with:

13.3.3.a. The standard radiation symbol;

13.3.3.b. The words "CAUTION-Radioactive Material"; and

13.3.3.c. The prescription number

13.3.4. The amount of radioactivity shall be determined by radiometric methods for each dose immediately prior to dispensing.

13.4. Distribution - Nuclear pharmacies may distribute approved radioactive drugs to any receiving pharmacy if the receiving pharmacy does not process the radioactive drugs in any manner nor violate or change the product packaging except that a licensed pharmacist may divide the product into individual doses.

W. Va. Code R. § 15-1-13