FDA releases first updated guidance in 27 years on container and closure systems for drugs and biologics

The FDA announced a draft guidance that updates the agency’s recommendations for evaluating container and closure systems used in the packaging of new drugs and biologics.

This revision is the first such update in 27 years, reflecting advances in technology and a growing focus on ensuring the quality and safety of pharmaceutical packaging throughout the product lifecycle.

The guidance outlines expectations for manufacturers to assess material compatibility, integrity testing, and risk management, aiming to help industry meet regulatory standards and protect patients.