3.0.0 1584 2023-01-11T13:22:17Z 2023-01-11T13:22:17Z Senate S S 2011-09-20 112 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2011-09-20T22:32:37Z 2011-09-20 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2011-09-20 Introduced in Senate IntroReferral 10000 9 Library of Congress B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO N B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2011-09-22 False B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2011-09-23 False Health Administrative remedies Business records Drug safety, medical device, and laboratory regulation Employment discrimination and employee rights Government information and archives Prescription drugs Health 00 2011-09-20 Introduced in Senate 2011-10-04T19:17:01Z 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.

]]> Drug Safety and Accountability Act of 2011 Display Title Drug Safety and Accountability Act of 2011 Official Title as Introduced A bill to provide for additional quality control of drugs. Introduced in Senate IS Short Titles as Introduced Drug Safety and Accountability Act of 2011 Introduced in Senate 2011-09-20T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112s1584is/xml/BILLS-112s1584is.xml 2011-09-20 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.