H.R. 1316 – Reading Mode

112th CONGRESS

1st Session

H. R. 1316

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.

Short title

This Act may be cited as the Stop Oxy Abuse Act of 2011.

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.