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GUIDANCE DOCUMENT

Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry August 2019

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2017-D-2163
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist applicants, manufacturers, packagers, and distributors (collectively referred to as firms) who choose to include child-resistant packaging (CRP) statements in their drug product labeling. The guidance discusses what information should be included to support CRP statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications. In addition to recommendations for labeling of prescription drug products, this guidance also includes recommendations for labeling both for nonprescription drug products approved under an NDA or ANDA and those that are marketed under the Over-the-Counter (OTC) Drug Review. This guidance is intended to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.

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All written comments should be identified with this document's docket number: FDA-2017-D-2163.

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