CPSC Posts FAQs on General Certification of Conformity for Products Subject to the PPPA

December 11, 2008

By Anne Marie Murphy

We have previously reported on the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) (here, here, and here), which makes a number of changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”).  Section 102(a)(1) of the CPSIA amends the Consumer Product Safety Act (“CPSA”) to require each importer or domestic manufacturer of any product that is subject to any CPSC rule, ban, standard, or regulation to issue a certificate that the product complies with such CPSC requirements.  The certificate must be “based on a test of each product or upon a reasonable testing program.”  This certification applies to drugs and dietary supplements that require child-resistant packaging (“CRP”) under the Poison Prevention Packaging Act (“PPPA”).

Yesterday, the CPSC posted on its website new Frequently Asked Questions (“FAQs”) that address the certification as it applies to PPPA products.  The FAQs confirmed the following:

  • The CPSC does not regulate drugs, including drugs intended for children, because such products are excluded from the definition of “consumer product” under the CPSA.  The CPSC does, however, regulate CRP for those products that are subject to the PPPA.
  • The importer of a PPPA-regulated product already in CRP or the domestic party that packages a PPPA-regulated substance in CRP must issue the general conformity certificate.
  • The child resistance and senior friendly testing data obtained with the procedures described at 16 C.F.R. § 1700.20 may be relied upon as the “reasonable testing program” to support the certification.  There is no expiration date for such testing, and the testing need not be repeated unless the packaging is changed.
  • There is no requirement to provide certification for the following types of shipments:  bulk drug product provided to pharmacies; empty vials and caps; and clinical trial drugs provided to physicians. 
Categories: Drug Development