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Pharmaceuticals / Regulatory Affairs

FDA Finalizes Guidance on Child-Resistant Packaging Labeling Statements

Aug. 19, 2019

The FDA issued final guidance on child-resistant packaging (CRP) statements in prescription and non-prescription drug product labeling.

Labeling statements should describe child-resistant packaging using words, not abbreviations or symbols, the agency says.

Drugmakers may include child-resistant packaging information on carton labeling and container labels if there is enough room. “Statements about CRP are most appropriately displayed on the side panels of the carton labeling and container labels” close to storage information, the agency says.

FDA regulations don’t dictate where to place CRP statements on nonprescription drug product labeling, but the agency advises firms that opt to include the statement in drug facts labeling to place it under the subheader “Other information” along with the storage statement.

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