Consumer Product Safety

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
Atripla® efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg Tablets
Biktarvy® bictegravir 50 mg/emtricitabine 200 mg /tenofovir alafenamide 25 mg Tablets
Blister Packs
bictegravir 50 mg/emtricitabine 200 mg /tenofovir alafenamide 25 mg Tablets
Low Dose
bictegravir 30 mg/emtricitabine 120 mg /tenofovir alafenamide 15 mg Tablets
Complera® emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg Tablets
Descovy® emtricitabine 200 mg/tenofovir alafenamide 25 mg Tablets
Blister Packs
emtricitabine 200 mg/tenofovir alafenamide 25 mg Tablets
Low Dose
emtricitabine 120 mg/tenofovir alafenamide 15 mg Tablets
Emtriva® emtricitabine, 200 mg Capsules
Emtriva® emtricitabine 10 mg/mL Oral Solution
Epclusa® sofosbuvir 400 mg/velpatasvir 100 mg Tablets
Genvoya® elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg Tablets
Harvoni® ledipasvir 90 mg/sofosbuvir 400 mg Tablets
Hepsera® adefovir dipivoxil, 10 mg Tablets
Letairis® ambrisentan, 5 mg Tablets
Letairis® ambrisentan, 10 mg Tablets
Letairis® ambrisentan, 10 mg Tablets
Odefsey® emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg Tablets
Tybost® cobicistat, 150 mg tablet Tablets
Ranexa® ranolazine extended release tablets, 500 mg Tablets
Ranexa® ranolazine extended release tablets, 1000 mg Tablets
Sovaldi® sofosbuvir, 400 mg Tablets
Stribild® elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg Tablets
Truvada® emtricitabine 100 mg/tenofovir disoproxil fumarate 150 mg Tablets
Truvada® emtricitabine 133 mg/tenofovir disoproxil fumarate 200 mg Tablets
Truvada® emtricitabine 167 mg/tenofovir disoproxil fumarate 250 mg Tablets
Truvada® emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg Tablets
Vemlidy® tenofovir alafenamide 25 mg Tablets
Viread® tenofovir disoproxil fumarate 40 mg/g Oral Powder
Viread® tenofovir disoproxil fumarate, 150 mg Tablets
Viread® tenofovir disoproxil fumarate, 200 mg Tablets
Viread® tenofovir disoproxil fumarate, 250 mg Tablets
Viread® tenofovir disoproxil fumarate, 300 mg Tablets
Vosevi™ sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg Tablets
Zydelig® idelalisib, 100 mg Tablets
Zydelig® idelalisib, 150 mg Tablets