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NORTH DAKOTA ADMINISTRATIVE CODE
TITLE 61. STATE BOARD OF PHARMACY
ARTICLE 5. RADIOPHARMACEUTICAL SERVICES
CHAPTER 1. RADIOPHARMACEUTICAL SERVICES
Date:
08/31/2009
Document:
61-05-01-03. General requirements for pharmacies providing radiopharmaceutical services.
1. A 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 in personal attendance at all times that the pharmacy is open for business. In emergency situations, in the pharmacist's absence, the pharmacist may designate one or more other qualified licensed professionals to have access to the licensed area. These individuals may obtain single doses of radiopharmaceuticals for the immediate emergency and must document such withdrawals in the control system.
2. 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 pharmacies handlingradiopharmaceuticals 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 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. Pharmacies providing radiopharmaceutical services shall only dispense radiopharmaceuticals which comply with acceptable standards of radiopharmaceutical quality assurance.
4. Pharmacies providing radiopharmaceutical services shall maintain records of acquisition and disposition of all radioactive drugs.
5. 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 prescription from a medical practitioner 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 prescription for a radiopharmaceutical shall be for an individual patient. A pharmacy may furnish radiopharmaceuticals for office use only to medical practitioners authorized to possess, use, and administer radiopharmaceuticals for an individual 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 cubic centimeters; (g) 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; and (d) the prescription number.
10. The amount of radioactivity shall be determined by radiometric methods for each individual dose immediately prior to dispensing.
11. Pharmacies may redistribute national drug administration approved radioactive drugs if the pharmacy does not process the radioactive drugs in any manner nor violate the product packaging.
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