The Purpose of the PPPA
Enacted in 1970, the PPPA (available in PDF and Text), requires a number of household substances to be packaged in child-resistant packaging. The packaging required by the PPPA must be designed or constructed to be significantly difficult for children under five years of age to open within a reasonable time, and not difficult for normal adults to use properly. For the sake of the elderly and handicapped who might have difficulty opening such containers, the Act provides that a regulated product available for purchase on store shelves may be packaged in one non-complying size provided it carries a warning that it is not recommended for use in households with children, and provided that the product is also supplied in complying popular size packages. Regulated prescription drugs may be dispensed in non-child-resistant packaging upon the specific request of the prescribing doctor or the patient. The Environmental Protection Agency regulates economic poisons, such as pesticides. Since the regulation has been in effect, there have been remarkable declines in reported deaths from ingestions by children of toxic household products including medications.
Help companies understand the meaning and application of CPSC's laws.
The Federal regulations for the PPPA are found in Title 16 CFR parts 1700 through 1702.
Frequently Asked Questions (FAQs) pertaining to Section 102 (of the Consumer Product Safety Improvement Act - CPSIA) Certification and the Poison Prevention Packaging Act - Posted 12/10/2008
Does the 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.
These FAQs are unofficial descriptions and interpretations of various features of CPSIA and do not replace or supersede the statutory requirements of the new legislation. These FAQs were prepared by CPSC staff, have not been reviewed or approved by, and may not necessarily reflect the views of, the Commission. Some FAQs may be subject to change based on Commission action.
Documents Relating to the PPPA
- Drugs dispensed for household use in clinical trials (pdf)
The PPPA is available above in text and PDF format. PDF (Portable Document Format) requires use of Adobe Acrobat Reader.
The PDF version of the PPPA has a clickable hyperlinked table of contents. To activate this feature, open the document in Acrobat Reader, click on the Navigation Pane icon, next to the printer icon. If the table of contents does not appear, click on the "Bookmarks." tab. The statutory citations in red are clickable hyperlinks to the statutory text.
All five statutes are available in a single book, with an index, from the Office of the Secretary, Consumer Product Safety Commission, Washington, D.C. 20207