FDA Releases Draft Labeling Guidance on Child-Resistant Packaging

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meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2.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.