NAC639.5838. Records of nuclear pharmacy when radiopharmaceutical is dispensed pursuant to investigational new drug application: Contents.

If a radiopharmaceutical is dispensed pursuant to the authority of an investigational new drug application approved by the United States Food and Drug Administration, the records of a nuclear pharmacy must include:

     1. An investigator’s protocol for the preparation of the radiopharmaceutical;

     2. A copy of the approval form or letter of the internal review board of the institution; and

     3. A letter from the manufacturer or sponsor indicating that the physician requesting the radiopharmaceutical is a qualified investigator.

     (Added to NAC by Bd. of Pharmacy, eff. 11-9-95)