Iowa Admin. Code r. 657-16.2

Current through Register Vol. 47, No. 6, September 18, 2024
Rule 657-16.2 - Definitions

"Authentication of product history" means, but is not limited to, identifying the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical.

"Authorized nuclear pharmacist" means a person currently licensed to practice pharmacy in Iowa who meets the qualifications established by rule 657-16.3 (155A).

"Board" means the Iowa board of pharmacy.

"Internal test assessment" means, but is not limited to, conducting those tests of quality assurance necessary to ensure the integrity of the test.

"Nuclearpharmacy" means a pharmacy providing radiopharmaceutical services.

"Radioactive drug" or "radiopharmaceutical" means a drug or device that contains a radioactive substance and is used to diagnose or treat disease.

"Radiopharmaceutical quality assurance" means, but is not limited to, the performance of appropriate chemical, biological and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine the radiopharmaceuticals' suitability for use in humans and animals, including internal test assessment authentication of product history and the keeping of proper records.

"Radiopharmaceutical service" means, but is not limited to, the preparation, dispensing, labeling and delivery of radiopharmaceuticals; the compounding 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, as necessary or required, of the 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 a nuclear pharmacy.

Iowa Admin. Code r. 657-16.2

Amended by IAB December 20, 2017/Volume XL, Number 13, effective 1/24/2018