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HR 486 113th Congress House Health Administrative law and regulatory procedures Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug, alcohol, tobacco use Food and Drug Administration (FDA) Prescription drugs

Stop Tampering of Prescription Pills Act of 2013

Introduced: March 21, 2013 Introduced by: Keating, William R. Democratic · Massachusetts See on congress.gov
This bill died when the 113th Congress ended
It never became law before the 113th Congress (2013–2014) 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
Feb 8, 2013
Referred to the Subcommittee on Health.
Feb 4, 2013
Referred to the House Committee on Energy and Commerce.
Feb 4, 2013
Introduced in House
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 Plain-English summary Congressional Research Service

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.

What's happening now February 8, 2013

Referred to the Subcommittee on Health.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 486: Stop Tampering of Prescription Pills Act of 2013. 113th Congress. Open America. https://openamerica.io/bill/113-HR-486/
MLA
"H.R. 486: Stop Tampering of Prescription Pills Act of 2013." 113th Congress, 2026, Open America, https://openamerica.io/bill/113-HR-486/.
Bluebook (legal)
H.R. 486, 113th Cong. (2026), https://openamerica.io/bill/113-HR-486/.
Markdown link
[H.R. 486: Stop Tampering of Prescription Pills Act of 2013](https://openamerica.io/bill/113-HR-486/)
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