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Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Container Closure Systems for Human Drugs and Biological Products." This document provides guiding principles for evaluating the quality of container closure systems (CCSs) used to package drugs and biological products, for human use. This includes CCSs that are also device constituent parts of combination products and CCSs used to package the drug or biological product constituent parts of combination products.
- Document type
- Notice
- Federal Register document number
- 2026-16638
- Published
- Aug 14, 2026
- Action
- Notice of availability.
- Docket
- FDA-2026-D-7957
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by October 13, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- CMC (chemistry, manufacturing & controls) Medical devices
Source: Federal Register API, document 2026-16638. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.