# 2025-20773: FDA Seeks Comments on Drug Compounding Information Collection

2025-20773, Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-24, effective Comments must be submitted by January 23, 2026. (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-20773
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-20773
- Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 52965
- Published: 2025-11-24
- Effective: Comments must be submitted by January 23, 2026.
- Comments close: 2026-01-23
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Seeks Comments on Drug Compounding Information Collection

## 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.

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection relating to human drug compounding.

## Effects PRIA read

- 60-Day Comment Window for Compounding Rules: benefit, low. 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…
- Paperwork and Reporting Burden Remains: cost, medium. 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 annu…
- FDA Guidance Documents for Reporting: benefit, low. 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 docu…

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## Sources
- [2025-20773 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/24/2025-20773/agency-information-collection-activities-proposed-collection-comment-request-human-drug-compounding)
- [2025-20773 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20773.pdf)

## Related
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- [Next: 2025-20774, Agency Information Collection Activities; Submission for Office of Management a…](https://policyrisk.com/federal-register/2025-20774)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-20773 (as of 2026-06-08).