Section 61-05-01-03 - General requirements for nuclear pharmacies providing radiopharmaceutical services1. A nuclear pharmacy providing radiopharmaceutical services shall only be managed by a qualified nuclear pharmacist. All personnel performing tasks in the preparation and distribution of radioactive drugs shall be under the direct supervision of the nuclear pharmacist. The nuclear pharmacist is responsible for all operations of the licensed area and shall be physically present at all times that the pharmacy is open for business. In emergency situations, in the nuclear pharmacist's absence, the nuclear pharmacist may designate one or more other qualified licensed professionals, who are authorized users, listed by name, on a radioactive materials license, to have access to the licensed area. These individuals may obtain single doses of radiopharmaceuticals, only if the single dose is already prepared by a qualified nuclear pharmacist, for the immediate emergency and must document such withdrawals in the control system.2. Nuclear pharmacies providing radiopharmaceuticals shall have adequate space, commensurate with the scope of services required and provided, meeting minimal space requirements established for all pharmacies in the state. The area shall be separate from the pharmacy areas for nonradioactive drugs and shall be secured from unauthorized personnel. All nuclear pharmacies handling radiopharmaceuticals shall provide a radioactive storage and product decay area, occupying at least twenty-five square feet [2.32 square meters] of space, separate from and exclusive of the hot laboratory, compounding, dispensing, quality assurance, and office area. A nuclear pharmacy handling radioactive drugs exclusively may be exempted from the general space requirements for pharmacies by obtaining a waiver from the state board of pharmacy. Detailed floor plans shall be submitted to the state board of pharmacy before approval of the license.3. Nuclear pharmacies providing radiopharmaceutical services shall only dispense radiopharmaceuticals which comply with acceptable standards of radiopharmaceutical quality assurance.4. Nuclear pharmacies providing radiopharmaceutical services shall maintain records of acquisition and disposition of all radioactive drugs and byproduct material for the duration of the license.5. Nuclear pharmacies providing radiopharmaceutical services shall comply with all applicable laws and regulations of federal and state agencies, including those laws and regulations governing nonradioactive drugs.6. Radioactive drugs are to be dispensed only upon a request from a licensee authorized to possess, use, and administer radiopharmaceuticals. A pharmacist providing radiopharmaceutical services may transfer to authorized persons radioactive materials not intended for drug use, in accordance with North Dakota rules and regulations pertaining to radiation control.7. A radiopharmaceutical may be provided only to a facility licensed under article 33-10, with an authorized user for the radioactive drug requested. A nuclear pharmacy must have on file a copy of the current radioactive materials license for the licensed facility requesting any radioactive drug before the radioactive drug is permitted to be dispensed to that facility. The radioactive drug must be delivered to the authorized address in the license for receipt, logging in, testing for contamination, and determining the current activity and then the dose is available to be administered to a patient.8. In addition to any labeling requirements of the state board of pharmacy for nonradioactive drugs, the immediate outer container of a radioactive drug to be dispensed shall also be labeled with: a. The standard radiation symbol;b. The words "Caution-Radioactive Material";e. The amount of radioactive material contained, in millicuries or microcuries;f. If a liquid, the volume in milliliters; andg. The requested calibration time for the amount of radioactivity contained.9. The immediate container shall be labeled with:a. The standard radiation symbol;b. The words "Caution-Radioactive Material";c. The name, address, and telephone number of the pharmacy; andd. The prescription number.10. The amount of radioactivity shall be determined by dose calibrator or other appropriate radiometric methods for each individual dose immediately prior to dispensing.11. Nuclear pharmacies may redistribute national food and drug administration approved radioactive drugs if the pharmacy does not process the radioactive drugs in any manner nor violate the product packaging.N.D. Admin Code 61-05-01-03
Effective August 1, 1983; amended effective October 1, 2012.General Authority: NDCC 28-32-02, 43-15-10(9), 43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14), 43-15-36
Law Implemented: NDCC 43-15-10(9), 43-15-10(11), 43-15-10(12), 43-15-10(13), 43-15-10(14), 43-15-36