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GUIDANCE DOCUMENT

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

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Final Level 1 Guidance

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

Docket Number:
2019-17433
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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-17433 .