North Dakota Administrative Code › Title 61 - Pharmacy, Board of › Article 61-05 - Radiopharmaceutical Services › Chapter 61-05-01 - Radiopharmaceutical Services › Section 61-05-01-03 - General requirements for nuclear pharmacies providing radiopharmaceutical services

Current through Supplement No. 393, July, 2024
1. 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";
c. The
						radionuclide;
d. The chemical
						form;
e. The amount of radioactive
						material contained, in millicuries or microcuries;
f. If a liquid, the volume in milliliters;
						and
g. The requested calibration
						time for the amount of radioactivity contained.