Drug and Device Accountability Act of 2008
Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.
Drug and Device Accountability Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a drug or device to be misbranded unless certain conditions related to registration of establishments, identification of prior transactions, labeling for country of manufacture, and provision of required information on importation are met.
Includes in the definition of "drug" a precursor ingredient.
Repeals the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs.
Expands the information required to be included for registration of establishments.
Deems a drug to be adulterated if certain conditions related to verification of identity and purity, identification of establishments, consistency with current manufacturing technologies, and conformity with good distribution and import practices are not met.
Sets forth provisions governing importation of a drug.
Sets forth required actions, including cessation of distribution, if there is a reasonable probability that a drug intended for human use would cause serious, adverse health consequences or death.
Establishes actions manufacturers must take regarding any defective drug.
Sets forth additional required certifications for submissions related to drugs and devices regarding accuracy of information submitted and personal knowledge of such information.
Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device.
Directs the Secretary of Health and Human Services to establish and maintain a corps of inspectors dedicated to inspections of foreign establishments and foreign facilities.
Authorizes the Secretary to conduct investigations, subpoena witnesses, and compel attendance of witnesses as necessary to carry out authority under the FFDCA or provisions governing the regulation of biological products.
Requires reports to the Secretary regarding certain civil actions involving a regulated product.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Introduced in Senate Formatted Text PDF Formatted XML
Cite this page
U.S. Congress. (2026). S. 3409: Drug and Device Accountability Act of 2008. 110th Congress. Open America. https://openamerica.io/bill/110-S-3409/
"S. 3409: Drug and Device Accountability Act of 2008." 110th Congress, 2026, Open America, https://openamerica.io/bill/110-S-3409/.
S. 3409, 110th Cong. (2026), https://openamerica.io/bill/110-S-3409/.
[S. 3409: Drug and Device Accountability Act of 2008](https://openamerica.io/bill/110-S-3409/)