To amend the Federal Food, Drug, and Cosmetic Act with respect to the sale or trade of prescription drugs that were knowingly caused to be adulterated or misbranded, and for other purposes.

May 24, 2005

Mr. SHAW introduced the following bill; which was referred to the Committee on Energy and Commerce

To amend the Federal Food, Drug, and Cosmetic Act with respect to the sale or trade of prescription drugs that were knowingly caused to be adulterated or misbranded, 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 `Prescription Drug Tampering Prevention Act of 2005'.

SEC. 2. SALE OR TRADE OF PRESCRIPTION DRUGS KNOWINGLY CAUSED TO BE ADULTERATED OR MISBRANDED; KNOWING PURCHASE OR TRADE.

Section 303(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)) is amended by adding at the end the following paragraph:

`(3) Notwithstanding paragraph (1) or (2), in the case of a person who violates section 301(a), 301(b), or 301(c) with respect to a drug that is subject to section 503(b)(1)(B), if the person knowingly caused the drug to be adulterated or misbranded and sells or trades the drug, or the person purchases or trades for the drug knowing or having reason to know that the drug was knowingly caused to be adulterated or misbranded, the person shall be fined in accordance with title 18, United States Code, or imprisoned for any term of years or for life, or both.'.

SEC. 3. OTHER CRIMINAL PENALTIES; CLARIFICATION REGARDING FINES.

Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)) is amended--

(1) in subsection (a)--

(A) in paragraph (1), by striking `shall be imprisoned' and all that follows and inserting the following: `shall be fined in accordance with title 18, United States Code, or imprisoned not more than one year, or both.'; and

(B) in paragraph (2), by striking `shall be imprisoned' and all that follows and inserting the following: `shall be fined in accordance with title 18, United States Code, or imprisoned not more than three years, or both.'; and

(2) in subsection (b)(1), in the matter after and below subparagraph (D), by striking `shall be imprisoned' and all that follows an inserting the following: `shall be fined in accordance with title 18, United States Code, or imprisoned not more than 10 years, or both.'.

END