Data / Federal rules / 2024-31356
Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
The Food and Drug Administration published this final rule in the Federal Register on January 6, 2025. Comments closed on April 7, 2025.
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What the agency says
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Complying With 21 CFR 211.110." This guidance, when finalized, will describe considerations for complying with the requirements for ensuring batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency's mission to protect and promote the public health. FDA encourages industry representatives and manufactures who are interested in using innovative control strategies to contact the Agency.
Key facts
- Document number
- 2024-31356
- Type
- Final rule
- Action
- Availability of draft guidance
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- January 6, 2025
- Comments due
- April 7, 2025
- Dates
- Submit either electronic or written comments on the draft guidance by April 7, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Docket
- Docket No. FDA-2024-D-5374
- Code of Federal Regulations
- 21 CFR 211
- Pages
- 3
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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.