Departures from manufacturer's instructions; elimination of recordkeeping requirements--NRC. Final rule.
The Nuclear Regulatory Commission (NRC) is amending its regulations to eliminate certain recordkeeping requirements related to the preparation and use of radiopharmaceuticals. Specifically, this rule eliminates recordkeeping requirements related to the justification for and a precise description of the departure, and the number of departures from the Food and Drug Administration (FDA) approved manufacturer's instructions. Both the NRC and the FDA staffs agree that the major trends in departures that may be identified by this recordkeeping are already discernible and collecting additional data is unnecessary.
D005568:Forms and Records Control / Q000331:legislation & jurisprudence*; D006077:Government Agencies / Q000331:legislation & jurisprudence; D008004:Licensure / Q000331:legislation & jurisprudence; D009683:Nuclear Medicine / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration