The Consumer Product Safety Commission (CPSC) enforces laws intended to protect the public against unreasonable risks of injuries and deaths associated with consumer products, which include pharmaceuticals. Two statutes applicable to OTC products are:
Poison Prevention Packaging Act (PPPA)
The PPPA requires specified products to be packaged in child-resistant packaging. While there are certain exemptions that allow companies to market non-complying package sizes (for use by the elderly or in households without young children), the list of affected products includes many OTC and prescription drugs.
Consumer Product Safety Improvement Act (CPSIA)
This Act is applicable only to those OTC drug products that are also subject to the provisions of the PPPA. It requires that manufacturers provide General Certificates of Conformity (to their distributors and retailers) that certify the products meet the requirements of the PPPA based on a reasonable testing program.
EAS Consulting Group can provide guidance and assistance to your company to ensure your products are in compliance with these CPSC requirements.