S.Amdt. 1601

SA 1601. Mr. VITTER submitted an amendment intended to be proposed by him to the bill S. 1042, to authorize appropriations for fiscal year 2006 for military activities of the Department of Defense, for military construction, and for defense activities of the Department of Energy, to prescribe personnel strengths for such fiscal year for the Armed Forces, and for other purposes; which was ordered to lie on the table; as follows:

At the end of the amendment, insert the following:

SEC. __. EFFECT OF CERTAIN PROVISIONS.

(a) Counterfeit-resistant Technologies.--

(1) Incorporation of counterfeit-resistant technologies into prescription drug packaging.--Notwithstanding any other provision of this title (or the amendments made by this title), the Secretary of Health and Human Services shall require that the packaging of any drug subject to section 503(b) incorporate--

(A) overt optically variable counterfeit-resistant technologies that are--

(i) visible to the naked eye, providing for visual identification of product authenticity without the need for readers, microscopes, lighting devices, or scanners;

(ii) similar to that used by the Bureau of Engraving and Printing to secure United States currency;

(iii) manufactured and distributed in a highly secure, tightly controlled environment; and

(iv) incorporate additional layers of non-visible covert security features up to and including forensic capability. described in paragraph (2) and comply with the standards of paragraph (3); or

(B) technologies that have an equivalent function of security, as determined by the Secretary.

(2) Standards for packaging.--For the purpose of making it more difficult to counterfeit the packaging of drugs subject to section 503(b), manufacturers of the drugs shall incorporate the technologies described in paragraph (2) into multiple elements of the physical packaging of the drugs, including blister packs, shrink wrap, package labels, package seals, bottles, and boxes.

(3) Effective date.--This subsection shall take effect 180 days after the date of enactment of this title.

(b) Website Information.--The Secretary of Health and Human Services shall publish, on the Internet website of the Food and Drug Administration described under section __4(g) of this title, information regarding the suspension and termination of any registration of a registered importer or exporter under section 804 of the Federal Food, Drug, and Cosmetic Act (as added by this title).

(c) User Fees.--Notwithstanding any other provisions of title (and the amendments made by this title), the Secretary may prohibit a registrant that is required to pay a user fee under section __4(e)(9) of this title and that fails to pay such user fee within 30 days after the date on which it is due, from importing or offering for importation a prescription drug under section 804 of the Federal Food, Drug, and Cosmetic Act (as added by this title) until such fee is paid.