Data / Federal rules / 2024-05801
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration published this proposed rule in the Federal Register on March 20, 2024. Comments closed on June 18, 2024.
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What the agency says
The Food and Drug Administration is proposing to establish criteria for the lists of drug products or categories of drug products that present demonstrable difficulties for compounding (Demonstrable Difficulties for Compounding Lists or DDC Lists) under certain sections of the Federal Food, Drug, and Cosmetic Act. Additionally, the Agency is proposing to identify the first three categories of drug products on both DDC Lists. Drug products or categories of drug products that appear on the DDC Lists cannot qualify for certain statutory exemptions, and therefore may not be compounded under, either section 503A or section 503B, respectively.
Key facts
- Document number
- 2024-05801
- Type
- Proposed rule
- Action
- Proposed rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- March 20, 2024
- Comments due
- June 18, 2024
- Dates
- Either electronic or written comments on the proposed rule must be submitted by June 18, 2024.
- Docket
- Docket No. FDA-2023-N-0061
- Regulation ID (RIN)
- 0910-AI31
- Code of Federal Regulations
- 21 CFR 216
- Topics
- Drugs; Prescription drugs
- Pages
- 13
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on drugs · Rules on prescription drugs · Published in March 2024
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.