Stop Tampering of Prescription Pills Act of 2012

Summary

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 Prescribes requirements governing when a drug which is not tamper-resistant may have its approval withdrawn or suspended.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 19 July 2012

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 19 July 2012

   Introduced

   Introduced in House

   Source: IntroReferral

3. 19 July 2012

   Introduced

   Introduced in House

   Source: IntroReferral

4. 20 July 2012

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 19 July 2012 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 19 July 2012

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 19 July 2012

  ViewDownloadOpen at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in House

  summary · EN · 19 July 2012

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Keating, William R. [D-MA-9] · D · Sponsor
• Rep. Bono, Mary [R-CA-44] · R · Sponsor
• Rep. Rogers, Harold [R-KY-5] · R · Sponsor
• Rep. Lynch, Stephen F. [D-MA-8] · D · Sponsor
• Rep. Rahall, Nick J., II [D-WV-3] · D · Sponsor
• Rep. Towns, Edolphus [D-NY-10] · D · Sponsor
• Rep. Tierney, John F. [D-MA-6] · D · Sponsor
• Rep. Buchanan, Vern [R-FL-16] · R · Cosponsor
• Rep. Hanabusa, Colleen [D-HI-1] · D · Cosponsor
• Rep. Rooney, Thomas J. [R-FL-17] · R · Cosponsor
• · hsif00 · Standing

Related records

No cross-record relationships stored yet.