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GUIDANCE DOCUMENT

Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry August 2017

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2017-D-2163
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics 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), biologic license applications (BLAs), and supplements to these applications. 

 

 

 

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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