U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry
  1. Regulatory Information

GUIDANCE DOCUMENT

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

Draft

Not for implementation. Contains non-binding recommendations.

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

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. 

 

 

 

3


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.