Okla. Admin. Code § 535:15-17-5

Current through Vol. 42, No. 6, December 2, 2024

Section 535:15-17-5 - General requirements

(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.

(g) A radiopharmaceutical shall be dispensed only to a licensed prescriber authorized by the Oklahoma Department of Environmental Quality Control, or if in another state the Nuclear Regulatory Commission or appropriate agreement state nuclear regulatory agency to possess, use and administer such drug. A radiopharmaceutical shall be dispensed only upon receipt of a prescription or medication order from such licensed prescriber. Otherwise, a radiopharmaceutical may be transferred to a person who is authorized to possess and use such drug for non-clinical applications as described in 535:15-17-5 subsection (k) below. Separate records will be kept for these transfers and sales, see drug supplier permit rules in 535:15-7.

(h) A nuclear pharmacy, upon receiving an oral prescription order for a radiopharmaceutical, shall immediately have the prescription order reduced to writing, or recorded in a data processing system.

(1) This writing or record shall contain at least the following:

(A) the name of the institution and prescriber, or prescribers' agent;

(B) the date of dispensing (or calibration) and the calibration time of the radiopharmaceutical,

(C) the name of the procedure,

(D) the name of the radiopharmaceutical,

(E) the dose or quantity of the radiopharmaceutical,

(F) the serial number assigned to the order for the radiopharmaceutical,

(G) any specific instructions, and

(H) the initials of the pharmacist who dispensed the order.

(2) Whenever an order is for a therapeutic or blood-product radiopharmaceutical, the patient's name must be obtained and recorded prior to dispensing.

(i) [RESERVED]

(1) The immediate outer container shield for a radiopharmaceutical to be dispensed, shall be labeled with:

(A) the name and address of the pharmacy,

(B) the name of the prescriber,

(C) the date of dispensing (or calibration),

(D) the serial number assigned to the order for the radiopharmaceutical,

(E) the standard radiation symbol,

(F) the words "Caution Radioactive Material",

(G) the name of the procedure,

(H) the radionuclide and chemical form,

(I) the amount of radioactivity and the calibration date and time,

(J) if a liquid, the volume,

(K) if a solid, the number of items or weight,

(L) if a gas, the number of ampules or vials,

(M) the BUD and time, and,

(N) the name of the patient or the words e.g., "Per Physician's Orders" in the absence of a patient name.

(2) When the prescription is for a therapeutic or blood-product radiopharmaceutical, the patient's name shall appear on the label. The requirements of this sub-section shall be met when the name of the patient is readily retrievable from the physician upon demand.

(j) The inner container label of a radiopharmaceutical to be dispensed shall be labeled with, but not limited to:

(1) the standard radiation symbol,

(2) the identity of the radionuclide,

(3) the amount of radioactivity and the calibration date and time,

(4) the name of the procedure, and

(5) serial number of the radiopharmaceutical.

(k) When a radiopharmaceutical is dispensed under the authority of an Investigational New Drug Application (IND), the nuclear pharmacy records shall include an investigator's protocol for the preparation of the radiopharmaceutical, a copy of the institutional radiation safety committee or equivalent radioactive use oversight committee approval, a copy of the Institutional Review Board approval form (or letter), and a letter from the manufacturer (sponsor) indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

(l) Each nuclear pharmacy shall have an adequate library and a current copy of state and federal regulations governing the safe storage, handling, use, dispensing, transport and disposal of radiopharmaceuticals.

Okla. Admin. Code § 535:15-17-5

Added at 14 Ok Reg 3027, eff 7-11-97; Amended at 15 Ok Reg 3272, eff 7-13-98; Amended at 24 Ok Reg 2262, eff 7-1-07

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.

Amended by Oklahoma Register, Volume 34, Issue 24, September 1, 2017, eff. 9/11/2017

Amended by Oklahoma Register, Volume 40, Issue 22, August 1, 2023, eff. 9/1/2023