The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Container Closure Systems for Human Drugs and Biological Products."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.
US Federal Register - FDA Guidance Notices · August 14, 2026
Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry
Original title: Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability
FDA draft guidance on evaluating quality of container closure systems for drugs, biologics, and combination products.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.