Home » FDA Releases Draft Labeling Guidance on Child-Resistant Packaging
FDA Releases Draft Labeling Guidance on Child-Resistant Packaging
August 4, 2017
Drug companies must ensure their products meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2.
Companies are not required to make a statement about whether packaging is child-resistant, but if they do the statement should appear under the heading, “How should I store drug X?” on consumer drug labels, in wording such as “Drug X comes in a child-resistant package,” the guidance said.
Companies should not claim that child-resistant packaging is “child-proof,” as the standards for child-resistant packaging are not designed to eliminate the risk of accidental ingestion completely.
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