3.0.0 2726 2023-01-11T13:18:53Z 2023-01-11T13:18:53Z House H HR 2009-06-04 111 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2009-06-08T18:14:38Z Referred to 2009-06-04T14:03:51Z 2009-06-08 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2009-06-04 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2009-06-04 Introduced in House IntroReferral Intro-H 9 Library of Congress 2009-06-04 Introduced in House IntroReferral 1000 9 Library of Congress I000057 Rep. Israel, Steve [D-NY-2] STEVE ISRAEL D NY 2 N A000022 Rep. Ackerman, Gary L. [D-NY-5] GARY ACKERMAN D NY L. 5 2009-06-18 False Health Administrative law and regulatory procedures Business records Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Fraud offenses and financial crimes Government information and archives Government studies and investigations Health information and medical records Health programs administration and funding Manufacturing Marketing and advertising Prescription drugs Retail and wholesale trades Health 00 2009-06-04 Introduced in House 2009-08-29T14:18:57Z Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services (HHS) within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred.

Deems a drug to be misbranded if it is not manufactured in accordance with the use of technologies that the Secretary determines are technically feasible and will assist in preventing such violations.

Requires the Secretary to establish alternative requirements to the extent that such requirements provide greater certainty on the chain of custody and are technically feasible.

Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations.

Requires the Secretary to educate the public and health care professionals on counterfeit drugs.

Directs the Secretary: (1) upon a finding of reasonable probability that a drug intended for human use would cause serious health consequences or death, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering or prescribing the drug; and (2) amend the order to include a recall if necessary.

]]> Counterfeit Drug Enforcement Act of 2009 Display Title Counterfeit Drug Enforcement Act of 2009 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes. Introduced in House IH Short Titles as Introduced Counterfeit Drug Enforcement Act of 2009 Short Titles as Introduced Tim Fagan's Law Introduced in House 2009-06-04T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111hr2726ih/xml/BILLS-111hr2726ih.xml 2009-06-08 Referred to the Subcommittee on Health. 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.