Have you seen the FDA’s guidance on child-resistant packaging statements in drug product labelling?

This guidance released by the United States (US) Food and Drug Administration (FDA) is intended to assist firms who choose to display child-resistant packaging (CRP) statements on their product’s labelling.

The guidance also discusses the information required in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs) and supplement to these applications, to support the use of CRP statements in labelling, for both prescription and non-prescription drug products.

During an FDA review of an NDA, ANDA, BLA or non-prescription drug application, data related to container closure systems are evaluated, such as the type of closure employed, the stability of the product in the container closure system, and whether the closure design is suitable for the product. CRPs are a type of container closure system which include safety caps and puncture-resistant and peel-push blisters. As healthcare professionals and patients may not be able to determine whether packaging is child-resistant solely by visual inspection, labelling statements are extremely useful in identifying this characteristic.

Generally, if a drug product is packaged using CRP, the CRP labelling statement should be in words and not abbreviated as this can be commonly misunderstood. Placement of the CRP statement must not interfere with other mandatory labelling information, and the statement should comply with the US Consumer Product Safety Commission’s (CPSC) regulatory standards.

Further in the guidance, detailed considerations are made for including CRP information in the prescribing information section, patient information section and carton and container labels. Then, the guidance outlines, with examples, the processes and verifications needed to include CRP statement information on original NDA, ANDA and BLA submissions or post-approval changes to packaging or labelling.

For non-prescription drug products marketed under an Over-the-Counter (OTC) drug review, FDA regulations do not specify where to place CRP statements and there is no designated process for submission of a written verification. However, if firms decide to include a CRP statement on their labelling, data demonstrating that the packaging meets the CPSC standards and follows the FDA guidance, should be retained.

“This guidance is intended to help ensure that such labelling is clear, useful, informative, and, to the extent possible, consistent in content and format.” The FDA maintains that all drug products, irrespective of the labelling and packaging, should be stored safely out of reach and sight of children to further reduce the risk of accidental paediatric ingestion. To view the full guidance, click here.