Health Law Daily Wrap Up, EXPERT INSIGHTS—FDA Issues Draft Guidance On Container Closure Systems For Human Drugs And Biological Products, (Aug 25, 2026)

Law Firms Mentioned:Steptoe LLP

By Joan Sylvain Baughan and Elisabeth Lewis of Steptoe LLP

On August 14, 2026, the US Food and Drug Administration (FDA) announced the availability of a new draft guidance for industry on "Container Closure Systems for Human Drugs and Biological Products" (the Draft Guidance).[1] Once finalized, this guidance will supersede FDA's 1999 guidance, "Container Closure Systems for Packaging Human Drugs and Biologics," and the related 2002 Questions and Answers document. While the 1999 guidance focused on the information on container closure systems (CCSs) that should be submitted to FDA in connection with drug submissions such as New Drug Applications (NDAs), the new Draft Guidance takes a slightly different slant in outlining considerations and providing recommendations for evaluating the quality of CCSs for pharmaceutical use both at the development stage (for both New Drug and Over-the-Counter (OTC) Generally Recognized as Safe and Effective (GRASE) drugs) and in support of drug submissions. FDA cites the development of novel drug products and new container closure technologies, which have led to advancements in the design, construction, and evaluation of new CCSs, as triggers for the need for additional testing and evaluation.

The Draft Guidance therefore sets out FDA's current thinking on a risk-based framework for evaluating the pharmaceutical quality of container closure systems used to package human drugs and biological products. It also includes in its scope CCSs that are device constituent parts of combination products (e.g., prefilled syringes, autoinjectors, metered dose inhalers) and CCSs used to hold the drug or biological product constituent part of a combination product. Like the previous guidance, the new Draft Guidance does not address packaging operations or child-resistant packaging.

The risk-based framework described in the Draft Guidance applies to CCS selection as well as to ongoing quality control. The framework addresses five general factors: (1) the safety of the packaging material; (2) protection against ingress, leakage, and environmental stressors; (3) performance, including drug-delivery functions where the CCS also serves as a device constituent part; (4) impacts of manufacturing processes such as sterilization, washing, or lyophilization on the CCS; and (5) the product's intended storage and handling, including cold-chain and freeze-thaw considerations. Placing a greater degree of emphasis on leachables (which differ from extractables in that leachables are present in the actual packaged drug product) than the 1999 guidance, the new Draft Guidance makes clear that selection of a CCS for a drug should be based on the characteristics of both the drug and the CCS. The Draft Guidance goes on to discuss the specific considerations that apply to common dosage forms by route of administration. FDA acknowledges that the likelihood of packaging/product interaction varies by dosage form and route of administration; however, the Draft Guidance explicitly states that even "low risk" categories such as oral and topical products are not risk-free and still warrant an adequate safety assessment. Nevertheless, the Agency continues to indicate that, for solid oral dosage forms, referencing FDA's Food Additive Regulations (in 21 C.F.R. Parts 174-186) may be acceptable in that regard.

In addition to discussing the risk-based factors for use in selecting an appropriate CCS, the Draft Guidance provides recommendations for quality assessment and ongoing quality control programs mapped across oral, injectable, inhalation, and topical/transdermal/transmucosal product classes. These recommendations provide that toxicological risk assessments for all leachables exceeding a recommended Qualification Threshold (QT) or Threshold of Toxicological Concern (TTC)-based Acceptable Intake (AI) (whichever is lower) should be performed. Notably, FDA also reaffirms its position that postconsumer recycled plastic should not be used to manufacture a primary packaging component. If postconsumer recycled plastic is used in a secondary packaging component, then the safety and compatibility of the material for its intended use should be addressed appropriately.

The comment period for this Draft Guidance is open until October 13, 2026. Although FDA guidance documents are nonbinding and do not create new legal obligations, this Draft Guidance, once finalized, will direct how FDA reviewers will evaluate CCS information. We are available to assist companies in preparing and submitting comments to FDA on the Draft Guidance, so please do not hesitate to contact us if this is of interest.

Joan Sylvain Baughan and Elisabeth Lewis

Steptoe LLP

1330 Connecticut Avenue, NW

Washington, DC 20036

United States

Tel.: +1 202-429 3000

E-mail: mche@steptoe.com

URL: www.steptoe.com/

Footnotes

1 Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability, 91 Fed. Reg. 52700 (Aug. 14, 2026).

Attorneys: Joan Sylvain Baughan and Elisabeth Lewis (Steptoe LLP).

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