RegulatoryGuideline · draft
Container Closure Systems for Human Drugs and Biological Products
🇺🇸 FDA · Fri 14 Aug 2026
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Container Closure Systems for Human Drugs and Biological Products."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.
Official guideline text: FDA ↗
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