H.R. 486: Stop Tampering of Prescription Pills Act of 2013

Feb 04, 2013
Referred to Committee
0% chance of being enacted
Track this bill
William Keating
Representative for Massachusetts's 9th congressional district
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Last Updated
Feb 04, 2013
9 pages
Related Bills
H.R. 6160 (112th) was a previous version of this bill.

Referred to Committee
Last Action: Jul 19, 2012


This bill was assigned to a congressional committee on February 4, 2013, which will consider it before possibly sending it on to the House or Senate as a whole.

Introduced Feb 04, 2013
Referred to Committee Feb 04, 2013
Reported by Committee ...
Passed House ...
Passed Senate ...
Signed by the President ...

3% chance of getting past committee.
0% chance of being enacted.

Only 11% of bills made it past committee and only about 3% were enacted in 2011–2013. [show factors | methodology]

Full Title

To amend the Federal Food, Drug, and Cosmetic Act to incentivize the development of abuse-deterrent drugs.


No summaries available.

14 cosponsors (7D, 7R) (show)

House Energy and Commerce


The committee chair determines whether a bill will move past the committee stage.

Primary Source

THOMAS.gov (The Library of Congress)

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H.R. stands for House of Representatives bill.

A bill must be passed by both the House and Senate in identical form and then be signed by the president to become law.

The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

We don’t have a summary available yet.

Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

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.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

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