Certification Requirements Under the PPPA: Frequently Asked Questions

Does CPSC regulate children’s drugs and do they need to be certified to the new CPSIA standards?

CPSC does not regulate children’s drugs and their accompanying dosing devices such as dosing cups or separate dosing droppers. These products are excluded from the definition of "consumer product" under the Consumer Product Safety Act. However, the CPSC regulates the child-resistant packaging for certain drugs as required by the Poison Prevention Packaging Act (PPPA). If any drug, for children or adults, is required by a CPSC regulation to be in child-resistant packaging, the importer or the domestic party that packages the children’s drug must issue a certificate of conformity with the special packaging requirements of the PPPA.

Does a dosing cup or similar device that accompanies a children’s drug need a certificate of compliance?

No. A dosing cup or similar device that accompanies a children’s drug is not a “children’s product” under the new CPSIA because it is not a consumer product. By definition these items are considered outside the scope of consumer products under the CPSA. However, a dosing dropper that can be used in lieu of a cap as a closure mechanism on a children’s drug would be subject to the PPPA’s special packaging requirements and require certification.

Who must certify that a substance required to be in special packaging is properly packaged?

The importer or the domestic party that packages a PPPA regulated substance in special packaging must issue the general conformity certificate. The child resistance and senior friendly testing data (also known as protocol data) obtained in accordance with the procedures described under 16 C.F.R. 1700.20 may be used by the importer or domestic packager to support its certification. The packager can rely upon this data as the basis for the reasonable testing program. There is no expiration date on these tests and no requirement to retest so long as the tests adequately reflect the current packaging used. (Commission staff does not consider the European tests (ISO 8317, EN 14375, and EN862) to be the equivalent of the tests required by the CPSC regulations.)

Do bulk drugs sold to pharmacies need certificates of conformity?

No. Bulk drugs provided to pharmacies are not subject to the special packaging requirements of the PPPA and therefore no certificate is required.

Do I have to certify my empty vials and caps?

No. The empty container is not subject to the special packaging requirements of the PPPA and does not require certification.

 

Do clinical trial drugs that go directly to the physician need a certification?

No. Certifications are not required for direct delivery of a clinical trial drug to a physician.

 

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This communication has been prepared for general informational purposes only and is based upon the facts and information presented. This communication does not, and is not intended to, constitute legal advice and has not been reviewed or approved by the Commission, and does not necessarily represent their views. Any views expressed in this communication may be changed or superseded by the Commission.