3.0.0 6160 2019-11-15T21:20:25Z 2019-11-15T21:20:25Z House H HR 2012-07-19 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. KEATING:H.R. 6160.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8 of the United States Constitution.[Page H5078]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-07-20T14:03:11Z Referred to 2012-07-19T14:02:00Z 2012-07-20 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-07-19 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-07-19 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-07-19 Introduced in House IntroReferral 1000 9 Library of Congress K000375 Rep. Keating, William R. [D-MA-10] William Keating D MA R. 10 N B001228 Rep. Bono Mack, Mary [R-CA-45] MARY BONO MACK R CA 45 2012-07-19 True R000395 Rep. Rogers, Harold [R-KY-5] HAROLD ROGERS R KY 5 2012-07-19 True L000562 Rep. Lynch, Stephen F. [D-MA-9] Stephen Lynch D MA F. 9 2012-07-19 True R000011 Rep. Rahall, Nick J., II [D-WV-3] NICK RAHALL D WV J. 3 2012-07-19 True T000326 Rep. Towns, Edolphus [D-NY-10] EDOLPHUS TOWNS D NY 10 2012-07-19 True T000266 Rep. Tierney, John F. [D-MA-6] JOHN TIERNEY D MA F. 6 2012-07-19 True B001260 Rep. Buchanan, Vern [R-FL-13] Vern Buchanan R FL 13 2012-08-02 False H001050 Rep. Hanabusa, Colleen W. [D-HI-1] Colleen Hanabusa D HI W. 1 2012-08-02 False R000583 Rep. Rooney, Thomas J. [R-FL-16] Thomas Rooney R FL J. 16 2012-08-02 False Health Administrative law and regulatory procedures Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug, alcohol, tobacco use Food and Drug Administration (FDA) Prescription drugs Health 00 2012-07-19 Introduced in House 2012-10-10T19:00:54Z Stop Tampering of Prescription Pills Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for tamper-resistant drugs: (1) containing as an active moiety (the part of the drug that makes it work the way it does) a controlled substance classified as opium, an opiate, or a derivative; (2) formulated for oral administration; (3) exhibiting physicochemical properties making them significantly more difficult or ineffective in altering the drug's characteristics for purposes of misuse or abuse; and (4) containing one or more additional ingredients intended to deter abuse through potential pharmacological effects.

Requires the Secretary to refuse a new drug application for any new (brand name) drug containing opium, an opiate, or a derivative as an active moiety that is not tamper-resistant if a tamper-resistant drug containing the same active moiety has been approved and has not been discontinued from marketing. Authorizes the Secretary to approve an application failing to meet such requirements, however, if approval is necessary to prevent or alleviate a drug shortage or otherwise address a significant unmet public health need.

Requires an abbreviated new (generic) drug application for a tamper-resistant drug to include testing information demonstrating that the generic drug resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Authorizes the Secretary to deny approval of a generic application if the listed drug is tamper-resistant and one or more of the generic drug's active moieties differ in any material respect from those of the listed drug.

Declares that an approved generic drug shall not be considered bioequivalent to, or as having the same therapeutic effect as, a listed drug if the listed drug becomes tamper-resistant unless and until the generic drug demonstrates that it resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug.

Prescribes requirements governing when a drug which is not tamper-resistant may have its approval withdrawn or suspended.

]]> Stop Tampering of Prescription Pills Act of 2012 Short Titles as Introduced Stop Tampering of Prescription Pills Act of 2012 Display Title Stop Tampering of Prescription Pills Act of 2012 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to incentivize the development of tamper-resistant drugs. Introduced in House 2012-07-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr6160ih/xml/BILLS-112hr6160ih.xml 2012-07-20 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.