CPSC Issues List of FAQs on Certification and Products Subject to the Special Packaging Requirements of the Poison Prevention Packaging Act
The US Consumer Product Safety Commission (CPSC) has issued a brief list of Frequently Asked Questions (FAQs) on the certification requirements specified at Section 102 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) and their applicability to products regulated under the Poison Prevention Packaging Act (PPPA). This additional guidance follows public statements by CPSC staff that aspirin and over-the-counter (OTC) and prescription drugs, among other items, subject to the special packaging requirements of the PPPA and manufactured after November 12, 2008 must be accompanied by a certificate of compliance (also called 'general certificate of conformity') prior to import or distribution in the United States.
According to the FAQs, the importer or domestic entity that packages a PPPA-regulated substance must issue a certificate stating the packaging complies with the special packaging requirements of the PPPA. As indicated in an earlier Arent Fox alert, it appears that private labelers and foreign manufacturers are not required to issue the certificate of compliance at this time.
The CPSIA requires the certificate of compliance to be based upon “a test of each product or upon a reasonable testing program.” According to the FAQs, the packager can rely upon the testing data for child resistance and senior friendly packaging obtained in accordance with the procedures discussed at 16 CFR § 1700.20 as the basis for the reasonable testing program. The FAQs further state that there is no expiration date on these tests and that packagers do not have to retest, provided the tests adequately reflect the current packaging used.1
With respect to dosing cups or similar devices that accompany a children’s drug, the FAQs state that such products are not considered “children’s products” and, thus, do not require certificates of compliance. If, however, a dosing dropper could be used in lieu of a cap as a closure mechanism on a children’s drug, then it would be subject to the PPPA’s special packaging requirements and require certification.
Finally, the FAQs identify some products that do not require certificates of compliance because they are exempt from the special packaging requirements of the PPPA. For example, empty containers, including empty vials and caps, do not need certificates. Clinical trial drugs that are delivered directly to a physician and bulk drugs that are provided to pharmacies also do not require certification.
For more information about the certification requirements for products subject to the special packaging requirements of the PPPA, please contact any of the individuals below.
Related Document:
1CPSC staff does not consider ISO 8317, EN 14375, and EN 862 to be the equivalent of the tests required at 16 C.F.R. Part 1700.
Georgia Ravitz
ravitz.georgia@arentfox.com
202.857.8939
James R. Ravitz
ravitz.james@arentfox.com
202.857.8903
Scott A. Cohn
cohn.scott@arentfox.com
212.484.3984
Robert G. Edwards
edwards.robert@arentfox.com
202.857.6346
Amy S. Colvin
colvin.amy@arentfox.com
202.857.6338