FDA announces new Draft Guidance on Container Closure Systems

On August 14, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of a new draft guidance entitled “Container Closure Systems for Human Drugs and Biological Products.” The document sets out the FDA’s current thinking on how to assess the quality of container closure systems (CCSs) used to package human drugs and biological products.

Container closure systems are a critical element of product quality. In addition to protecting a drug or biological product during storage and distribution, they must help ensure that the product maintains its quality, safety, and effectiveness throughout its shelf life. Depending on the product and the packaging configuration, relevant considerations may include protection against moisture, oxygen, light, and microbial contamination, as well as compatibility between the product and its packaging. The draft guidance is intended to provide a structured, risk-based framework for addressing these considerations.

The document focuses on the quality assessment and quality control of packaging materials and components. It applies to applications for human drugs and biological products, including amendments and supplements to approved applications. The scope also covers CCSs that serve as device constituent parts of combination products, as well as systems used to package the drug or biological product constituent parts of combination products. In addition, the guidance addresses drug products legally marketed under section 505G of the Federal Food, Drug, and Cosmetic Act without an approved application under section 505.

The FDA’s approach is explicitly risk based. Accordingly, the nature and extent of the evaluation should reflect the specific characteristics of the product, the container closure system, and its intended use. Companies should therefore be able to demonstrate that the selection, qualification, and control of a CCS are scientifically justified and appropriately linked to the relevant quality risks. The draft guidance provides general principles, while further topic-specific guidance is expected to add more detailed recommendations in selected areas.

The planned additional guidance is expected to address approaches for evaluating and characterizing novel container closure systems, as well as specific quality attributes and testing considerations. It is also intended to provide further information on extractables and leachables assessments and the associated toxicological risk evaluations. These topics may be particularly relevant for innovative or complex packaging systems, where the interaction between packaging materials and the drug product requires a more detailed assessment.

Anyone interested may submit comments by 13 October 2026 so that these can be taken into account before the final version is drawn up. Read the draft guidance document "Container Closure Systems for Human Drugs and Biological Products" on the FDA’s website.