Skip to main content
HR 6160 112th Congress House

Stop Tampering of Prescription Pills Act of 2012

Official title: To amend the Federal Food, Drug, and Cosmetic Act to incentivize the development of tamper-resistant drugs.

Introduced: July 19, 2012 Introduced by: Keating, William R. Democratic · Massachusetts See on congress.gov
Health Administrative law and regulatory proceduresAdministrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulation
More subjectsShow fewer subjects
Drug, alcohol, tobacco useFood and Drug Administration (FDA)Prescription drugs
This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 20, 2012
Referred to the Subcommittee on Health.
Jul 19, 2012
Referred to the House Committee on Energy and Commerce.
Jul 19, 2012
Introduced in House
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Latest action July 20, 2012

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 6160: Stop Tampering of Prescription Pills Act of 2012. 112th Congress. Open America. https://openamerica.io/bill/112-HR-6160/
MLA
"H.R. 6160: Stop Tampering of Prescription Pills Act of 2012." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-6160/.
Bluebook (legal)
H.R. 6160, 112th Cong. (2026), https://openamerica.io/bill/112-HR-6160/.
Markdown link
[H.R. 6160: Stop Tampering of Prescription Pills Act of 2012](https://openamerica.io/bill/112-HR-6160/)
Report a problem