By David Swain
Last updated on September 16, 2026
FDA recently announced the availability of a draft guidance for comment entitled “Container Closure Systems for Human Drugs and Biological Products”. The document is intended to provide guiding principles for evaluating the quality of container closure systems (CCSs) used to package drug products, including OTC drug topical products. Comments on the draft guidance are due by October 13, 2026. After considering comments the FDA will develop and publish the final guidance document.
The draft guidance directs manufacturers of drug products to evaluate CCSs using a risk-based framework, including quality assessment and quality control of packaging materials and components. The recommendations primarily address drug manufacturers’ selection of CCSs and does not address filling, packaging, labeling, or other packaging operations.
Key Risk-Based Considerations
FDA recommends assessing the suitability of a CCS based on the characteristics of both the drug formulation and the packaging system, with particular attention to potential interactions between the product and packaging materials. Key considerations include the safety of packaging materials, the protection the closure gives to the formula, the performance and stability of the product within the CCS, the manufacturing process potential deviations, and the conditions used in storing and handling the container during transportation and use.
Bottom Line for Topical OTC Products
The FDA draft guidance reinforces that container closure selection is a product-specific, risk-based consideration—not simply a packaging specification exercise. For topical liquids, particularly formulations containing alcohol, manufacturers should have a documented rationale demonstrating that the selected CCS is:
- Compatible
- Protective
- Safe
- Controlled
- Stable
The most significant practical consideration for OTC topical products is likely to be documented assessment of formulation/package interactions, stability, protection, and potential leachables, supported by an appropriate level of testing based on the risks of the formulation and CCS.
The draft guidance signals a new emphasis for FDA which will likely start appearing as findings in FDA GMP 483s and GMP Warning Letters. Manufacturers should act now to ensure these formal risk assessments of CCSs are completed and available in their files for the next FDA audit.
SRC Ready to Help
Scientific & Regulatory Consultants, Inc., is available to evaluate current risk assessments on file with an OTC drug manufacturer and/or begin proactively completing these risk assessments in preparation for the next FDA audit.
