Stop Tampering of Prescription Pills Act of 2013
Latest action · Feb 8, 2013 Referred to the Subcommittee on Health.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedFeb 4, 2013
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 15
Members who signed on, in the order they did. Signatures ran from Feb 4, 2013 to Jul 10, 2014, with 5 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-HI | Colleen Hanabusa | Original | Feb 4, 2013 |
| R-KY | Harold Rogers | Original | Feb 4, 2013 |
| D-WV | Nick J. Rahall II | Original | Feb 4, 2013 |
| D-MA | Stephen F. Lynch | Original | Feb 4, 2013 |
| R-FL | Vern Buchanan | Original | Feb 4, 2013 |
| D-MA | Edward J. Markey | Mar 13, 2013 | |
| D-MA | John F. Tierney | Mar 13, 2013 | |
| R-AL | Robert B. Aderholt | Mar 13, 2013 | |
| R-GA | Jack Kingston | Mar 14, 2013 | |
| D-MA | Joseph P. Kennedy III | Mar 14, 2013 | |
| R-FL | Thomas J. Rooney | Mar 14, 2013 | |
| R-VA | Frank R. Wolf | Mar 21, 2013 | |
| R-NY | Michael G. Grimm | Apr 11, 2013 | |
| D-MA | James P. McGovern | Feb 4, 2014 | |
| D-IL | Janice D. Schakowsky | Jul 10, 2014 |
Actions 3
Everything that happened, newest first.
- Feb 8, 2013Referred to the Subcommittee on Health.
- Feb 4, 2013Introduced in House
- Feb 4, 2013Referred to the House Committee on Energy and Commerce.
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 1
Each version as it was printed, newest first.
- Feb 4, 2013Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.