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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20727, Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
The FDA is officially classifying home test kits that detect non-viral germs causing sexually transmitted infections as Class II devices, meaning they have special safety rules but fewer hurdles than the strictest category. This change, effective October 9, 2026, helps make these tests safer and easier to get, benefiting patients and innovators alike. If you make or use these home test kits, this update means better access and clear safety standards without extra costs or delays.
Previous / Next Documents
Previous: 2025-23852, Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026
Starting October 1, 2025, companies that make or request orders for over-the-counter (OTC) drugs will pay new fees to the FDA for fiscal year 2026. These fees help the FDA keep OTC drugs safe and effective. If you’re a manufacturer or submitter, get ready for updated costs that will last through September 30, 2026.
Next: 2025-23862, Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA
The FDA has set the official review period for the drug ROMVIMZA, which helps the company extend its patent protection. This means the drug maker could get more time to exclusively sell ROMVIMZA, potentially affecting competition and profits. People can challenge the dates or the company’s effort in the review process by early and mid-2026 deadlines.