Child Resistant Packaging: FDA Finalizes Guidance on Labeling Statements

Regulatory NewsRegulatory News | 13 August 2019 |  By 

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on child-resistant packaging (CRP) statements that should be included in the labeling of prescription and over-the-counter (OTC) drugs.
The seven-page final guidance comes two years after FDA released the draft version for comment. FDA says it considered the comments submitted to the public docket and has edited the guidance for clarity.
Under US Consumer Product Safety Commission (CPSC) regulations, certain consumer products, including many prescription and OTC drugs, are subject to special packaging standards. The products subject to special packaging standards are listed in 16 CFR 1700, though FDA notes that drugmakers may choose to use CRP even when it is not required, such as for bulk packages of prescription drugs distributed to pharmacies for repackaging.
Similarly, FDA says the guidance applies to all FDA-regulated drugs that bear CRP statements, “regardless of whether CRP is required.”
FDA also says that all drugs “should be stored safely out of reach and sight of children” to further reduce the risk of accidental exposure and points out that CRP “is not designed to completely eliminate the possibility of an accidental pediatric ingestion.”
“This 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,” FDA writes.
The guidance provides recommendations for the content and format of CRP statements in various sections of labeling as well as on the cartons and containers for prescription and nonprescription drugs.
The guidance also provides examples of the types of information that should be included in CRP statements, such as descriptions of how a drug is supplied, statements indicating that a drug comes in a child-resistant package and instructions for product storage.
Additionally, the guidance provides recommendations regarding the process for including CRP statements in the labeling for prescription and nonprescription drugs approved under an application.
FDA notes that while there is no defined process for verifying that CRP statements for OTC monograph products meet CPSC standards, firms “should retain the data demonstrating that the packaging meets applicable CPSC standards and follow the labeling recommendations in this guidance.”
FDA, Federal Register Notice


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