Regulatory News

Child-Resistant Packaging Statements in Drug Labels: FDA Drafts Guidance

The US Food and Drug Administration (FDA) on Wednesday published draft guidance to help ensure child-resistant packaging (CRP) statements in drug labels is clear, useful, informative and, to the extent possible, consistent in content and format.

The draft, now open for comments, is meant to assist applicants, manufacturers, packagers and distributors in determining what information should be included to support the CRP statements.

Background

Child-resistant packaging is meant to help prevent children from ingesting drugs, and FDA says it advocates that all drugs, irrespective of the type of packaging, be stored safely out of reach and sight of children to further the overall public health efforts to address this safety issue.

"Because health care professionals and consumers may not be able to determine on visual inspection whether the packaging is child-resistant, a labeling statement may help to identify this attribute," the agency explains.

The draft guidance notes that to ensure CRP statements on labeling are not false or misleading, they should only be used when the drug packaging has been shown to comply with the applicable US Consumer Product Safety Commission (CPSC) regulatory standards and test procedures for CRP.

Guidance

FDA, while stressing that the CRP statements should be linked clearly to a particular package, says that if a firm chooses to include information about CRP in the prescribing information, such information "should appear in the HOW SUPPLIED/STORAGE AND HANDLING section as this is generally where practitioners look to ascertain information about a product's packaging."

Information about the CRP in patient labeling, FDA adds, "should appear under a heading titled 'How should I store Drug X?' The description should be consistent with the CRP statement(s) included in the HOW SUPPLIED/STORAGE AND HANDLING section of the full prescribing information."

And if a firm chooses to include information about the CRP on carton labeling and container labels, FDA says it may do so "as long as there is sufficient space to include such information in addition to information required to be included. If space permits, a firm may also include a storage statement in conjunction with the CRP statement to recommend that the package be kept out of reach of children, particularly for those packages which may be dispensed directly to patients."

The guidance also features details on nonprescription drug products and nonprescription drug products marketed under an OTC monograph.

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