Stop Oxy Abuse Act of 2011 - Directs the Commissioner of Food and Drugs (FDA), within 90 days, to take such actions as may be necessary to modify the approval of, and limit any subsequent approval of, any drug containing controlled-release oxycodone hychloride to use for the relief of severe-only pain instead of moderate-to-severe pain.
Applies any such modification to drugs introduced into interstate commerce 180 days after enactment of this Act.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1316 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 1316
To direct the Commissioner of Food and Drugs to modify the approval of
any drug containing controlled-release oxycodone hydrochloride to limit
such approval to use for the relief of severe-only instead of moderate-
to-severe pain, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 1, 2011
Mrs. Bono Mack (for herself, Mr. Rogers of Kentucky, Mr. Lynch, Mr.
Wolf, Mr. Buchanan, and Mr. Mack) introduced the following bill; which
was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To direct the Commissioner of Food and Drugs to modify the approval of
any drug containing controlled-release oxycodone hydrochloride to limit
such approval to use for the relief of severe-only instead of moderate-
to-severe pain, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Stop Oxy Abuse Act of 2011''.
SEC. 2. LIMITING APPROVAL OF DRUGS CONTAINING CONTROLLED-RELEASE
OXYCODONE HYDROCHLORIDE TO USE FOR RELIEF OF SEVERE-ONLY
PAIN.
(a) In General.--Not later than 90 days after the date of the
enactment of this Act, the Commissioner of Food and Drugs shall take
such actions as may be necessary--
(1) to modify the approval of any drug containing
controlled-release oxycodone hydrochloride under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) to
limit such approval to use for the relief of severe-only
instead of moderate-to-severe pain; and
(2) to limit any subsequent approval of a drug containing
controlled-release oxycodone hydrochloride under such section
to use for the relief of severe-only pain.
(b) Applicability.--Any modification required by subsection (a)(1)
shall apply to drugs introduced or delivered for introduction into
interstate commerce on or after the date that is 180 days after the
date of the enactment of this Act.
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Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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