# Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
> **Food and Drug Administration** · Availability of draft guidance. · Published 2025-01-06 · 90 FR 563
## Document
- **Document number:** 2024-31356
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 90 FR 563
- **CFR reference:** 21 CFR 211
- **Publication date:** 2025-01-06
- **HHS docket:** Docket No. FDA-2024-D-5374
## Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Complying With 21 CFR 211.110."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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2025/01/06/2024-31356/considerations-for-complying-with-21-cfr-211110-draft-guidance-for-industry-availability)
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