Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 17 - Nuclear Pharmacy › Section 535:15-17-5 - General requirements

Current through Vol. 41, No. 20, July 1, 2024
(a) A permit to
				operate a nuclear pharmacy shall only be issued to a person who is, or who
				employs a qualified nuclear pharmacist. All personnel performing tasks in the
				preparation and distribution of radiopharmaceuticals and ancillary drugs shall
				be under the direct supervision of a qualified nuclear pharmacist, who shall be
				in personal attendance when the pharmacy is open for business. The nuclear
				pharmacist-in-charge shall be responsible for all operations of the
				pharmacy.
(b) The permit to operate
				a nuclear pharmacy is effective only so long as the pharmacy also holds a
				current Radioactive Material License issued by the Oklahoma Department of
				Environmental Quality Control, or if in another state the Nuclear Regulatory
				Commission, or appropriate agreement state nuclear regulatory agency. Copies of
				inspection reports from Oklahoma Department of Environmental Quality Control,
				or if in another state the Nuclear Regulatory Commission, or appropriate
				agreement state nuclear regulatory agency shall be available for Board
				inspection.
(c) Nuclear pharmacies
				shall have adequate space and equipment, commensurate with the scope of
				services required and provided, meeting minimal space requirements established
				for all pharmacies in the state. All pharmacies handling radiopharmaceuticals
				shall include, but not be limited to, the following areas: radiopharmaceutical
				preparation/dispensing area; radioactive material shipping / receiving area;
				radioactive material storage area; and radioactive waste decay area.
(d) The nuclear pharmacy professional service
				area shall be secured from unauthorized personnel and must be totally enclosed
				and lockable.
(e) Nuclear
				pharmacies shall maintain records of acquisition, inventory and disposition of
				all radioactive drugs and other radioactive materials in accordance with Board
				and Nuclear Regulatory Commission statutes and regulations.
(f) Radiopharmaceutical preparation,
				compounding, dispensing and repackaging shall be done in accordance with
				accepted standards of practice as defined in <USP 825>. The Board
				recognizes that the preparation of radiopharmaceuticals involves the
				compounding skills of the nuclear pharmacist to assure that the final drug
				product meets accepted professional standards.
(1) Immediate use. A preparation (including
				preparations with minor deviations) and/or dispensing of a sterile
				radiopharmaceutical that is limited for a single patient. Only sterile
				conventionally manufactured drug products (e.g., NDA, ANDA) or drugs produced
				under an approved IND or RDRC protocol may be used. Administration must begin
				within 4 hours of the first container puncture or exposure of any critical site
				involved (e.g., syringe tip, needle hub, or needle) to ambient air, whichever
				is first. Beyond use date may be 4 hours.
(2) Facility design and controls must be in
				place to minimize the flow of lower-quality air into the more controlled areas.
				Air supplied to the classified areas should be introduced through HEPA filters
				that are located in the ceiling. Returns should be low on the wall unless a
				visual smoke study demonstrates an absence of stagnant airflow where
				particulate will accumulate.