Container Closure Systems for Human Drugs and Biological Products August 2026

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/container-closure-systems-human-drugs-and-biological-products?utm_medium=email&utm_source=govdelivery FDA issues Draft Guidance on Container Closure Systems for Human Drugs and Biological Products Today, FDA is announcing the availability of a draft guidance for industry titled, “Container Closure Systems for Human Drugs and Biological Products.” This draft guidance provides recommendations regarding pharmaceutical quality considerations (e.g., chemistry, manufacturing, and controls (CMC)) for container closure systems (CCSs) used for human drugs and biological products. It discusses both general principles and specific considerations for the development and assessment of CCSs for drug products and drug substances. https://www.federalregister.gov/documents/2026/08/14/2026-16638/container-closure-systems-for-human-drugs-and-biological-products-draft-guidance-for-industry?utm_medium=email&utm_source=govdelivery FDA intends to issue additional, topic-specific guidances to further address areas such as evaluation of novel CCSs and information about specific quality attributes and testing. This draft guidance applies to applications for human drugs and biological products, including amendments and supplements to approved applications, as well as to combination products. It also applies to certain drug products marketed without an approved application under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Public comments on the draft guidance can be submitted to the docket. When finalized, this draft guidance will replace FDA’s previous guidances Container Closure Systems for Packaging Human Drugs and Biologics (May 1999) and Container Closure Systems for Packaging Human Drugs and Biologics — Questions and Answers (May 2002), and reflect updated recommendations based on advances in science and technology.