FDA Reviews Rules for Safe Drug Production Practices
Published Date: 2/20/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about making and handling medicines safely, including new tech in drug manufacturing. This affects drug makers and anyone involved in producing medicines, with a comment deadline of April 21, 2026. No big costs or changes yet—just a chance to help shape future rules!
Analyzed Economic Effects
5 provisions identified: 3 benefits, 2 costs, 0 mixed.
Estimated Annual Recordkeeping Burden
FDA estimates annual recordkeeping for CGMP as 1,260 API manufacturers (322,560 records at 0.82 hours each = 264,499 hours) and 3,270 finished pharmaceuticals manufacturers (977,730 records at 0.64 hours each = 625,747 hours). The total annual records are 1,300,319 with a total annual burden of 890,455 hours.
Medical Gas Burden Removed Here
FDA removed activities and burden attributable to medical gas requirements from this collection, resulting in a decrease of 396,293 hours and 639,491 responses annually; medical gas CGMP requirements are now under OMB control number 0910-0906.
60-Day Public Comment Window
The FDA is asking for public comment on its proposed information collection related to Current Good Manufacturing Practice (CGMP) and the Advanced Manufacturing Technologies (AMT) designation program. Comments must be submitted by April 21, 2026, through https://www.regulations.gov or by mail to the Dockets Management Staff.
AMT Designation Program Burden
The Advanced Manufacturing Technologies (AMT) designation program is included in the information collection; FDA estimates 20 recordkeepers with 20 total records for AMT activities and an average burden of 10 hours per record, totaling 200 hours annually.
No Capital or O&M Costs
FDA states there are no capital or operating and maintenance (O&M) costs associated with this information collection.
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Key Dates
Department and Agencies
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