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.


Gilead Products

  • Name
    Dosage
    Type
  • efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
    Tablets
  • emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg
    Tablets
  • emtricitabine, 200 mg
    Capsules
  • emtricitabine 10 mg/mL
    Oral Solution
  • ledipasvir 90 mg/sofosbuvir 400 mg
    Tablets
  • adefovir dipivoxil, 10 mg
    Tablets
  • ambrisentan, 5 mg
    Tablets
  • ambrisentan, 5 mg
    Tablets
  • ambrisentan, 10 mg
    Tablets
  • ambrisentan, 10 mg
    Tablets
  • ranolazine extended release tablets, 500 mg
    Tablets
  • ranolazine extended release tablets, 1000 mg
    Tablets
  • sofosbuvir, 400 mg
    Tablets
  • elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
    Tablets
  • emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
    Tablets
  • tenofovir disoproxil fumarate 40 mg/g
    Oral Powder
  • tenofovir disoproxil fumarate, 150 mg
    Tablets
  • tenofovir disoproxil fumarate, 200 mg
    Tablets
  • tenofovir disoproxil fumarate, 250 mg
    Tablets
  • tenofovir disoproxil fumarate, 300 mg
    Tablets
  • idelalisib, 100 mg
    Tablets
  • idelalisib, 150 mg
    Tablets