FDA: Draft Guidance on Assessing Container Closure Systems for Drugs and Biologics

On 14 August 2026, the US Food and Drug Administration (FDA) announced the publication of a new draft guidance document entitled ‘Container Closure Systems for Human Drugs and Biological Products’. The document sets out the FDA’s current thinking on the evaluation of the quality of container closure systems (CCS) used for the packaging of human drugs and biological products.

Container closure systems are intended not only to protect the medicinal product during storage and transport, but also to ensure that its quality, safety and efficacy are maintained throughout its shelf life. Depending on the product and packaging, protection against moisture, oxygen, light or microbiological contamination, as well as compatibility between the product and the packaging, can play an important role.

The new FDA guidance is intended to help companies assess these aspects using a structured and risk-based approach. The nature and scope of the required assessment should be guided by the specific characteristics of the product, the packaging system and the intended use. For companies, this means that the selection and control of a CCS should be justified in a transparent manner and tailored to the relevant quality risks. The Draft Guidance provides general principles for this; supplementary, topic-specific guidance documents are intended to address further details at a later date. 

The recommendations apply to

• Submissions for medicinal products for human use and biological products, including amendments and supplements to already authorised submissions.
• Container closure systems used as components of combination products.

The planned amendments cover the following topics:

• Evaluation and characterisation of novel container closure systems
• Specific quality attributes and testing requirements
• Recommendations on extractables and leachables testing and the associated toxicological risk assessments. 

These topics can be of particular importance for the assessment of material compatibility and product safety, especially in the case of complex or innovative packaging systems. 

Interested parties may submit comments by 13 October 2026 so that these can be taken into account before the final version is drawn up. Please refer to the draft guidance ‘Container Closure Systems for Human Drugs and Biological Products’ on the FDA’s website.

Source:

FDA: FDA issues draft guidance on assessing container and closure systems for drugs and biologics