Custom Drugs in Spotlight: FDA Info Collection Feedback
Published Date: 2/23/2026
Notice
Summary
The FDA is asking for public feedback on how it collects information about drug compounding, where pharmacists mix medicines just for patients who need them. This helps keep these special medicines safe and effective while making sure patients can still get them. Comments are open until March 25, 2026, so pharmacists and facilities should weigh in soon!
Analyzed Economic Effects
3 provisions identified: 0 benefits, 3 costs, 0 mixed.
503A Pharmacy Reporting and Recordkeeping Burden
Pharmacies that compound under section 503A have reporting and recordkeeping duties. FDA estimates 45 respondents with ~197 reports each (8,879 total annual responses) at 0.87 hours per response (7,968 total hours) for 503A reporting, plus 503A recordkeeping estimated at 90 responses at 1 hour each (90 total hours).
Adverse Event Reporting and Recordkeeping
Outsourcing facilities must submit adverse event reports under section 503B(b)(5) in accordance with 21 CFR 310.305(e)(1), generally within 15 calendar days with 15-day follow-ups as needed, and must maintain adverse event records for 10 years. FDA estimates 503B AER reporting covers 55 respondents with 55 total AERs (average 1.10 hours each = 61 hours) and associated recordkeeping estimated at 880 hours (55 respondents × 16 hours). Reports must be submitted electronically using Form FDA 3500A (OMB control number 0910-0291).
503B Outsourcing Facility Reporting Burden
If you operate or register an outsourcing compounding facility under section 503B, you must submit reports identifying the drugs you compound as required by sections 503B(b)(1)–(3). FDA estimates this activity covers about 75 respondents making ~108 reports each (8,111 total annual responses) at an average 0.2 hours per response, totaling 214 hours annually.
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