3.0.0 486 2019-11-15T21:18:17Z 2019-11-15T21:18:17Z House H HR 2013-02-04 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. KEATING:H.R. 486.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8 of the United States Constitution.[Page H344]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-02-08T22:21:51Z Referred to 2013-02-04T19:04:20Z 2013-02-08 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-02-04 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-02-04 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-02-04 Introduced in House IntroReferral 1000 9 Library of Congress K000375 Rep. Keating, William R. [D-MA-9] William Keating D MA R. 9 N R000395 Rep. Rogers, Harold [R-KY-5] HAROLD ROGERS R KY 5 2013-02-04 True R000011 Rep. Rahall, Nick J., II [D-WV-3] NICK RAHALL D WV J. 3 2013-02-04 True L000562 Rep. Lynch, Stephen F. [D-MA-8] Stephen Lynch D MA F. 8 2013-02-04 True H001050 Rep. Hanabusa, Colleen W. [D-HI-1] Colleen Hanabusa D HI W. 1 2013-02-04 True B001260 Rep. Buchanan, Vern [R-FL-16] Vern Buchanan R FL 16 2013-02-04 True M000133 Rep. Markey, Edward J. [D-MA-5] Edward Markey D MA J. 5 2013-03-13 False T000266 Rep. Tierney, John F. [D-MA-6] JOHN TIERNEY D MA F. 6 2013-03-13 False A000055 Rep. Aderholt, Robert B. [R-AL-4] ROBERT ADERHOLT R AL B. 4 2013-03-13 False K000220 Rep. Kingston, Jack [R-GA-1] JACK KINGSTON R GA 1 2013-03-14 False K000379 Rep. Kennedy, Joseph P., III [D-MA-4] Joseph Kennedy D MA P. 4 2013-03-14 False R000583 Rep. Rooney, Thomas J. [R-FL-17] Thomas Rooney R FL J. 17 2013-03-14 False W000672 Rep. Wolf, Frank R. [R-VA-10] FRANK WOLF R VA R. 10 2013-03-21 False G000569 Rep. Grimm, Michael G. [R-NY-11] Michael Grimm R NY G. 11 2013-04-11 False M000312 Rep. McGovern, James P. [D-MA-2] JAMES MCGOVERN D MA P. 2 2014-02-04 False S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2014-07-10 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 2013-02-04 Introduced in House 2013-03-04T22:37:53Z Stop Tampering of Prescription Pills Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for abuse-deterrent 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 abuse-deterrent if an abuse-deterrent 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 an abuse-deterrent 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 abuse-deterrent 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 abuse-deterrent 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 abuse-deterrent may have its approval withdrawn or suspended.

]]> Stop Tampering of Prescription Pills Act of 2013 Short Titles as Introduced Stop Tampering of Prescription Pills Act of 2013 Display Title Stop Tampering of Prescription Pills Act of 2013 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to incentivize the development of abuse-deterrent drugs. Introduced in House 2013-02-04T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr486ih/xml/BILLS-113hr486ih.xml 2013-02-08 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.