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CPSC Clarifies PPPA Certification Obligations for Drugmakers

Date: Dec 17, 2008


The Consumer Product Safety Commission (CPSC) recently added several new "frequently asked questions" about the Consumer Product Safety Improvements Act (CPSIA) aimed at clarifying the certification process for drugs required to be packaged in child-resistant packaging. Child-resistant packaging is required on certain drugs for children and for adults under the Poison Prevention Packaging Act (PPPA). Therefore, any importer or domestic party that packages a drug product using child-resistant materials must issue a general certificate of conformity under the provisions of of the CPSIA. Any child resistant and senior friendly testing data obtained in accordance with the procedures described under 16 C.F.R. 1700.20 may be used to support the certification, and it should be noted that test results do not have an expiration date. While drugs and any associated items for dosing, including cups and droppers, are not within the jurisdiction of the CPSC as they are regulated by the federal Food and Drug Administration (FDA), the FAQs also specify that any dosing dropper that is also used as a cap for a product requires a certificate as well. Items that are exempted from the PPPA are bulk drugs shipped to pharmacies, empty containers, and clinical trial drugs. Retail or in-store pharmacies who purchase child-resistant packaging should obtain certifications of PPPA compliance for the packaging they use but under §102 of the CPSIA retailers do not need to create certifications and certifications do not need to be provided to consumers.

The CPSC's FAQs and other information about the CPSIA are available at http://www.cpsc.gov/ABOUT/Cpsia/cpsia.html.