FDA Reviews PET Drug Production Paperwork
Published Date: 12/29/2025
Notice
Summary
The FDA is asking for public feedback on keeping rules that make sure PET drugs are made safely and correctly. This affects companies that produce these special medical drugs, helping keep patients safe without adding new costs. Comments are open until January 28, 2026, so now’s the time to speak up!
Analyzed Economic Effects
5 provisions identified: 0 benefits, 5 costs, 0 mixed.
Estimated annual recordkeeping burden
FDA estimates the total annual recordkeeping burden for 21 CFR part 212 at 98,833 hours covering 197,665 records. The agency provides breakdowns: Academia/Small Firms & High-Risk Component Manufacture Records: 76 recordkeepers, ~62,644 total records, ~50,862 hours; Corporate Firm Records: 91 recordkeepers, ~131,686 total records, ~45,728 hours; External Control Testing Laboratory Records: 23 recordkeepers, 3,335 total records, ~2,243 hours.
CGMP applies to PET drug makers
If you operate a positron emission tomography (PET) drug production facility — academic, hospital, or commercial — you must follow the FDA's Current Good Manufacturing Practice (CGMP) rules in 21 CFR part 212. The rule covers personnel, quality assurance, facilities and equipment, control of components, production/process controls, laboratory controls, finished product acceptance, packaging/labeling, distribution, complaint handling, and records.
Increase in burden from new small facilities
FDA reports the estimated burden increased by 14,348 hours and 12,851 records compared to prior estimates, and attributes this adjustment to an increase in the estimate of the number of small firms due to new facilities.
One-year record retention requirement
You must keep all records required by 21 CFR part 212 at the PET drug production facility or another reasonably accessible location, ensure they are legible and protected from deterioration or loss, and make them readily available for FDA review and copying. All records and documentation must be retained for at least 1 year from the date of final release (including conditional final release) of a PET drug product.
Sterility-failure disclosure burden
For sterility testing failures under 21 CFR 212.70, FDA estimates 11 respondents will make 3 disclosures each (33 total disclosures) with an average burden of 2.5 hours per disclosure, totaling 83 hours annually.
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