New FDA guidance on Child-Resistant Packaging

The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include child-resistant packaging statements in their drug product labeling. The guideline specifies that CRP statements on the product labeling should be verified by a written verification that the CRP meets the Consumer Product Safety Commission (CPSC) standards. The agency also recommends that applicants / manufacturers etc. retain the data demonstrating that the packaging meets applicable CPSC standards.

Prescription Drug Products and Nonprescription Drug Products Approved Under an Application

Original NDA, BLA, or ANDA submission

A written verification that the CRP meets the CPSC standards under 16 CFR 1700 should appear in the container closure section of Module 3.2.P.7 Container Closure System of the Electronic Common Technical Document (eCTD).

An example of the written verification may be “We verify in this submission that the following package (or packages) meet CPSC’s standards under 16 CFR 1700".

Postapproval Change

If there is a postapproval change to the package or labeling of a product, it should be referred to appropriate regulations and guidances to determine the appropriate pathway to implement these changes. Submissions for changes to add CRP statements on the labeling should verify that the CRP meets the CPSC’s standards and the written verification (see example above) should appear in the detailed container closure description section of Module 3.2.P.7 of the eCTD.

Nonprescription Drug Products Marketed Under the OTC Drug Review

There is no defined process for submission of a written verification to FDA that a nonprescription drug product meets the CPSC’s standards. However, if manufacturers decide to include a CRP statement on the labeling of a nonprescription drug product marketed under an OTC monograph, they should retain the data demonstrating that the packaging meets the CPSC standards and follow the labeling recommendations provided.

For more information please see FDA´s final guidance Child-Resistant Packaging Statements in Drug Product Labeling.

Go back

GMP Conferences by Topics