Text: H.R.1366 — 113th Congress (2013-2014)All Information (Except Text)

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Introduced in House (03/21/2013)


113th CONGRESS
1st Session
H. R. 1366


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

March 21, 2013

Mr. Lynch (for himself, Mr. Fitzpatrick, Mr. Rogers of Kentucky, Mr. Rahall, Mr. Keating, Mr. Wolf, and Ms. Slaughter) 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 2013”.

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.