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 Prescribes requirements governing when a drug which is not tamper-resistant may have its approval withdrawn or suspended.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 19 July 2012

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• Introduced in House (PDF)

  Introduced in House · EN · 19 July 2012

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• Introduced in House

  summary · EN · 19 July 2012

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