Section 639.5838 - Records of nuclear pharmacy when radiopharmaceutical is dispensed pursuant to investigational new drug application: ContentsIf 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; and3. A letter from the manufacturer or sponsor indicating that the physician requesting the radiopharmaceutical is a qualified investigator.Nev. Admin. Code § 639.5838
Added to NAC by Bd. of Pharmacy, eff. 11-9-95