FDA Seeks Comments on Drug Compounding Information Collection
Published Date: 11/24/2025
Notice
Summary
The FDA wants your thoughts on how they collect info about making special human drugs under sections 503A and 503B. This affects pharmacies and drug makers who customize medicines for patients. Comments are open until January 23, 2026, so speak up now—this could shape paperwork and processes, but no new fees are mentioned.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Paperwork and Reporting Burden Remains
FDA says the information collection supports registration and drug reporting for outsourcing facilities (section 503B), adverse event reporting (section 503B(b)(5)), and State memoranda of understanding under section 503A. FDA retained its currently approved burden estimates: a total of 17,191 annual responses and 9,214 total annual hours; for example, 503A reporting is estimated at 8,879 responses and 7,968 hours annually.
60-Day Comment Window for Compounding Rules
The FDA is asking for public comments on its information collection about human drug compounding under sections 503A and 503B. Comments may be submitted electronically or by mail and must be received by January 23, 2026; this is your chance to tell FDA about paperwork and process concerns, and the notice says no new fees are mentioned.
FDA Guidance Documents for Reporting
FDA references guidance documents to help compounding entities comply: "Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B" (January 3, 2017) and "Adverse Event Reporting for Outsourcing Facilities Under Section 503B" (October 8, 2015). These documents describe who must report, report formats, content, timing, and submission methods.
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Key Dates
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