To amend the Federal Food, Drug, and Cosmetic Act to provide for the implementation of the program under section 804 of such Act, and for other purposes.

February 13, 2003

Mr. BERRY (for himself, Mrs. EMERSON, Mr. TAYLOR of Mississippi, Mr. HOLDEN, Mr. ALEXANDER, Mr. TURNER of Texas, Mr. SCOTT of Georgia, Ms. LORETTA SANCHEZ of California, Mr. MOORE, Mr. HILL, Mr. STENHOLM, Mr. CRAMER, Ms. HARMAN, Mr. ISRAEL, Ms. SLAUGHTER, Ms. WOOLSEY, Mr. SANDERS, Mr. CROWLEY, Mr. FROST, and Mr. HINCHEY) introduced the following bill; which was referred to the Committee on Energy and Commerce

To amend the Federal Food, Drug, and Cosmetic Act to provide for the implementation of the program under section 804 of such Act, 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 Price Reduction Act'.

SEC. 2. IMPLEMENTATION OF SECTION 804 OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) IN GENERAL- Section 804 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) is amended--

(1) by striking subsection (l); and

(2) by redesignating subsection (m) as subsection (l).

(b) REGULATIONS- The Secretary of Health and Human Services shall promulgate a final rule for carrying out section 804 of the Federal Food, Drug, and Cosmetic Act not later than one year after the date of the enactment of this Act. The effective date for such final rule may not be later than 30 days after the date on which the final rule is promulgated.

(c) LABELING- Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:

`(w) If it is a covered product imported into the United States pursuant to section 804, unless, upon commercial distribution of such product in the United States, the product bears labeling that identifies the country from which the product was imported, that provides the name and address of the importer of the product, and that provides the name and address of the person who exported the product to the United States.'.

END