H.R. 1483: Drug Safety Enhancement Act of 2011

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H.R. 1483: Drug Safety Enhancement Act of 2011

112th Congress · introduced 2011-04-12 · Health · Latest: Referred to the Subcommittee on Health.

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Official title

Drug Safety Enhancement Act of 2011

Plain summary

Drug Safety Enhancement Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand drug establishment registration requirements to include foreign drug establishments and establishments manufacturing, preparing, propagating, compounding, or processing excipients of drugs (i.e., inactive drug additives). Requires the Secretary of Health and Human Services (HHS) to collect registration fees. Requires drug manufacturers to: (1) implement an effective quality system that requires compliance with current good manufacturing practices and timely communication of product quality issues; (2) establish risk management procedures that ensure effective risk assessment, control, and communication; and (3) establish procedures that ensure the safety, identity, quality, strength, purity, and security of all drugs and other materials used by the manufacturer. Requires drug establishments to maintain records on the supply chain of the drug, ingredients, and raw materials. Establishes the frequency of inspections of drug establishments. Prohibits delaying or limiting an inspection. Gives the Secretary authority to order the recall of, detain, destroy, and seize drugs as necessary. Establishes civil and criminal penalties for violations of FFDCA provisions. Authorizes the Secretary to require documentation of an imported drug and refuse admission if such documentation is not provided. Requires the Secretary to: (1) require drug importers to register and to comply with good importer practices, (2) require a customs broker with respect to drugs to register, and (3) establish a corps of inspectors dedicated to inspections of foreign drug facilities and establishments. Requires drug establishments, importers, and customs brokers to have a unique identifier. Deems a finished dosage form drug to be misbranded if the manufacturer's website does not list country of origin labeling for each active pharmaceutical ingredient and the place of manufacture of the finished dosage form of such drug. Gives the Commissioner of the Food and Drug Administration (FDA) subpoena authority. Establishes whistleblower protections.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

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PSI Sci description of the legislative step (not an opinion).

The strongest published arguments

Alternatives

Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.

How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Dingell, John D. [D-MI-15] · 15 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Frank Pallone, Jr. (D-NJ), Diana DeGette (D-CO), James P. McGovern (D-MA), Eleanor Holmes Norton (D-DC), Marcy Kaptur (D-OH)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Sources

• Congressional Research Service summary (Introduced in House)
• Congress.gov
• Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-112hr1483.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/112/hr>

Record fed-us-cong112-hr1483 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112