FDA Asks for Feedback on Drug Compounding Forms
Published Date: 5/26/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about making custom human drugs under special rules (Sections 503A and 503B). This affects pharmacies and drug makers who mix medicines just for patients. You’ve got until July 27, 2026, to share your comments—no cost changes yet, just a chance to help shape the paperwork process!
Analyzed Economic Effects
4 provisions identified: 0 benefits, 3 costs, 1 mixed.
Estimated Annual Paperwork Burden
FDA estimates the total annual reporting burden for human drug compounding at 9,500 hours and 17,461 responses. The agency provides a detailed breakdown (for example, 7,725 hours for 503A reporting and 880 hours for 503B recordkeeping of adverse events).
Adverse Event Reporting Deadlines and Records
Outsourcing facilities must submit serious and unexpected adverse event reports within 15 calendar days and submit follow-up reports within 15 calendar days of new information; they must retain adverse event records for 10 years and submit reports electronically via Form FDA 3500A, including current product labeling in the report.
503A Hospital/Health System Documentation Rules
Under FDA guidance for 503A compounding, a hospital or health system pharmacy relying on a prescriber's determination that a compounded drug is not essentially a copy must keep a statement from the prescriber that: (1) specifies the change from the commercially available product, (2) says the compounded drug will be administered only to patients for whom the change produces a significant difference, and (3) describes the intended patient population; those statements must be maintained on file.
New Cross‑Sector Stakeholder Group Burden
FDA added a cross-sector stakeholder group to this information collection: up to 30 stakeholders, about 9 meetings/activities each (270 responses total), adding an estimated 540 hours of respondent burden annually (about 2 hours per response).
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Key Dates
Department and Agencies
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