In a Federal Register announcement today (here), the FDA announced the availability of a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling. The guidance provides information on the type of statement that may be made on child-resistant packaging for drug products.
As a reminder, the FDA has not regulated child-resistant packaging since 1973, when jurisdiction was transferred from the FDA to the U.S. Consumer Products Safety Commission (CPSC). However, “[B]ecause of FDA’s authority to regulate labeling for prescription and nonprescription drug products, if firms choose to make statements in their labeling for such products about child-resistant packaging, such statements must comply with FDA’s statutory and regulatory requirements.”
The FR notice goes on to say:
The guidance explains that to ensure that CRP statements on labeling are not false or misleading, such statements should only be used when the drug product packaging has been shown to comply with CPSC regulatory standards and test procedures for CRP, as applicable. This guidance is intended to apply to FDA-regulated drug products that bear CRP statements, regardless of whether CRP is required for such products under 16 CFR 1700. For example, bulk packages of prescription drugs that are shipped to pharmacies for repackaging by a pharmacist are not required to utilize CRP, but a firm may nevertheless choose to use CRP (and a CRP statement) for such drugs.
Drugs that fail to make appropriate label statements or where products fail to meet the CPSC requirements are considered to be misbranded. Industry has always had questions concerning the appropriate wording and placement of CRC labeling statements and this guidance should provide the industry with current FDA expectations and recommendations for Rx and OTC application products, as well as OTC monograph products, relative to how, what, and where to place the container’s child-resistant information.
A complete copy of the guidance can be found here.