The information in this section is intended for visitors outside the United States.
The Consumer Product Safety Improvement Act of 2008 (CPSIA) requires that every manufacturer of a product that is subject to a consumer product safety rule, ban, standard, or regulation enforced by the Consumer Product Safety Commission (CPSC) issue a general conformity certificate that certifies that the product (the child-resistant package) complies with all applicable regulations. This requirement applies to products that are imported or domestically manufactured (U.S.A.).
The regulation that applies to Gilead products is the Poison Prevention Packaging Act (PPPA). The certificate must certify that based on a reasonable test program, the package complies with PPPA rules, bans, standards, and regulations.
The certificate must "accompany" each shipment of product and the CPSC permits electronic certificates to satisfy this requirement. An electronic certificate will be deemed to accompany a shipment if the certificate can be accessed via a world wide web URL or other electronic means as soon as the product enters domestic commerce or in the case of imports, when the product is available for customs inspection into the United States.
The details and requirements of the general conformity certificates under the CPSIA are published in 16 C.F.R. Part 1110 Certificates of Compliance. Additional information on CPSIA can be found on the CPSC website by clicking here.
To access a certificate, click on the link for the applicable product below. Note: only the products requiring special packaging (per 16 CFR § 1700) are included on this list.
emtricitabine 100 mg/tenofovir disoproxil fumarate 150 mg
emtricitabine 133 mg/tenofovir disoproxil fumarate 200 mg
emtricitabine 167 mg/tenofovir disoproxil fumarate 250 mg