FDA issues finalized guidance of Labeling statements on the Child Resistant Packaging


The FDA recently issued finalized labeling statements, which it released two years ago, in context to the Child Resistant Packaging (CRP) for over-the-counter (OTC) and prescription drugs. Although the 16 CFR 1700 enlists the products that are subjected to special packaging standards, the drugmakers can choose to comply with the CRP even when it is not necessary. This can be for bulk packages of prescription drugs distributed to pharmacies for repackaging.

The guidance further explains that the CRP labeling statements must not be misleading and provide false information and must only be used when the drug packaging entirely complies with the CPCS (Consumer Product Safety Commission) regulatory standards and CRF test procedures. The guidance also provides finalized statements for content and CRP statements formats for various sections in labels and containers for prescription drugs.