H.R. 486 · 113th Congress
Stop Tampering of Prescription Pills Act of 2013
Key: what the circles and colors mean
Each circle is a bill. The ring fills as it moves through Congress:
Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.
Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.
Never voted on. It didn't reach a floor vote before the 113th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
KeatingSponsor15 cosponsors · 8 D, 7 R
R
Buchanan
CH
D
Hanabusa
SL
D
Lynch
NR
D
Rahall
HR
R
Rogers
RA
R
Aderholt
EM
D
Markey
JT
D
Tierney
JK
R
Kingston
JK
D
Kennedy
TR
R
Rooney
FW
R
Wolf
MG
R
Grimm
JM
D
McGovern
JS
D
Schakowsky5 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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…
What it does: CRS summary · Introduced in House · Feb 4, 2013
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Stop Tampering of Prescription Pills Act of 2013
Latest action (Feb 8, 2013): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Feb 4, 2013
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.