Skip to main content
S 1584 112th Congress Senate

Drug Safety and Accountability Act of 2011

Official title: A bill to provide for additional quality control of drugs.

Introduced: September 23, 2011 Introduced by: Bennet, Michael F. Democratic · Colorado See on congress.gov
Health Administrative remediesBusiness recordsDrug safety, medical device, and laboratory regulationEmployment discrimination and employee rights
More subjectsShow fewer subjects
Government information and archivesPrescription drugs
This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Sep 20, 2011
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 20, 2011
Introduced in Senate
 Ask about this bill AI · grounded in the bill text

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.

AI answers can be imperfect; always confirm against the full bill text.

 Latest action September 20, 2011

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Plain-English summary Congressional Research Service

Drug Safety and Accountability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require each registered drug producer to have in effect and implement a quality management plan to ensure the quality and safety of: (1) each drug, (2) each active and inactive ingredient of each drug, and (3) materials used in the manufacture of each active ingredient. Authorizes the Secretary of Health and Human Services (HHS) to order an establishment to promptly revise its quality management plan in response to a significant threat to public health.

Requires each registered drug producer to report on each producer, manufacturer, distributor, and shipper involved in the production of a drug or the production or transport of the active ingredients of a drug. Requires the Secretary to develop and maintain information systems to track and assess every establishment that is involved in the manufacturing, preparation, propagation, compounding, or processing of a drug or active ingredient of a drug.

Deems a drug to be adulterated if it was produced in an establishment that does not comply with the requirements of this Act.

Gives the Secretary authority to: (1) order an immediate cessation of distribution, or a recall, of a drug; and (2) administer oaths and issue subpoenas.

Revises provisions regarding civil penalties for FFDCA violations related to drugs for human use, including to consider each day a violation continues to be a separate violation.

Authorizes the Secretary to share information subject to a trade secret exemption with: (1) other federal, state, or local agencies, foreign government agencies, and relevant international organizations; and (2) the public, as necessary to protect the public health.

Sets forth whistleblower protection provisions.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1584: Drug Safety and Accountability Act of 2011. 112th Congress. Open America. https://openamerica.io/bill/112-S-1584/
MLA
"S. 1584: Drug Safety and Accountability Act of 2011." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-S-1584/.
Bluebook (legal)
S. 1584, 112th Cong. (2026), https://openamerica.io/bill/112-S-1584/.
Markdown link
[S. 1584: Drug Safety and Accountability Act of 2011](https://openamerica.io/bill/112-S-1584/)
Report a problem