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 |
| Complera® | emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg | Tablets |
| Descovy® | emtricitabine 200 mg/tenofovir alafenamide 25 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 |