N.D. Admin. Code 61-05-01-02
1. "Authentication of product history" includes identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical.
2. "Internal test assessment" includes conducting those tests of a quality assurance necessary to ensure the integrity of the test.
3. "Radiopharmaceutical quality assurance" includes the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.
4. "Radiopharmaceutical service" includes the compounding, dispensing, labeling, and delivery of radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance of radiopharmaceutical quality assurance; the responsibility for advising, where necessary or where regulated, of therapeutic values, hazards, and use of radiopharmaceuticals; and the offering or performing of those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of radiopharmaceuticals.
N.D. Admin Code 61-05-01-02
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