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# Drug Labeling Child-Resistant Packaging Statements
- URL: https://www.fdaweb.com/drug-labeling-child-resistant-packaging-statements/
- Published: 2019-08-13T12:00:00.000Z
- Updated: 2026-09-15T01:43:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144759

FDA has issued a final guidance, *Child-Resistant Packaging Statements in Drug Product Labeling*, to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging statements in their drug product labeling. The [document](https://www.fda.gov/media/129881/download?utm%5Fcampaign=SBIA%3A%20FDA%20Announces%20Availability%20of%20Final%20Guidance%20-%20Child-Resistant%20Packaging&utm%5Fmedium=email&utm%5Fsource=Eloqua) discusses what information should be included to support child-resistant packaging statements in labeling for NDAs, ANDAs, BLAs, and supplements to these applications.

The 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 drug review. It is intended to help ensure that such labeling is clear, useful, informative and, to the extent possible, consistent in content and format.

Included in the guidance are Introduction, Discussion, Labeling (prescription drug products and nonprescription drug products), and Process for Including Statements Regarding Child-Resistant Packaging on the Labeling (prescription and nonprescription drug products approved under an application and nonprescription drug products marketed under the OTC drug review).