(A) Nuclear/radiologic pharmacy practice refers to 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 radiopharmaceuticals and other drugs. Nuclear/radiologic pharmacies also shall adhere to the regulations established by the Nuclear Regulatory Commission as they pertain to the practice of nuclear pharmacy.
The pharmacist-in-charge of a nuclear pharmacy must be a qualified nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals and ancillary drugs must be under the direct supervision of a qualified nuclear pharmacist.
(B) Revocation of the radioactive materials license from the Department of Health and Environmental Control voids the pharmacy permit immediately and the permit must be returned to the board within ten days.
(C) Copies of all regulatory inspection reports must be made available upon request for board inspection.
(D) The nuclear pharmacist-in-charge shall notify the Board of Pharmacy by letter of the outcome of any hearings that are conducted pursuant to citations for violations of state or federal laws or regulations governing radioactive materials. Notification must be within thirty days of the date of the hearing.
(E) Space and equipment must be adequate to the scope of services required and provided. All nuclear pharmacy facilities shall have a radiopharmaceutical preparations/dispensing area, a radioactive material shipping/receiving area, and a radioactive waste decay area. Airflow hoods must be certified annually for operational efficiency in accordance with federal standards by a qualified technician and must be recertified each time the hood is moved. Certification must be attached to the front of the hood and shall state the date certification was granted. Prefilters must be changed in accordance with manufacturer's specifications. Changes must be documented by date and initials. Documentation must be retained for two years.
(F) For purposes of this section, "qualified nuclear pharmacist" means a pharmacist who holds a current license issued by the South Carolina Board of Pharmacy, and who is either certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties, or meets minimal standards of training for status as an authorized user of radioactive material, as specified by the Nuclear Regulatory Commission.
HISTORY: 1998 Act No. 366, Section 1.