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Full Text of this Amendment

SA 1063. Mr. DORGAN (for himself and Ms. Snowe) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the appropriate place in the amendment, insert the following:
SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES.
(a) In General.--Notwithstanding any other provision of this Act, the requirement that the Secretary of Health and Human Services certify that the implementation of the title of this Act relating to the Importation of Prescription Drugs will pose no additional risk to the public's health and safety and will result in a significant reduction in the cost of covered products to the American consumer shall not apply to the requirement that the Secretary, not later than 18 months after the
date of enactment of this Act, require that the packaging of any prescription drug incorporates--
(1) a standardized numerical identifier unique to each package of such drug, applied at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing); and
(2)(A) overt optically variable counterfeit-resistant technologies that--
(i) are visible to the naked eye, providing for visual identification of product authenticity without the need for readers, microscopes, lighting devices, or scanners;
(ii) are similar to that used by the Bureau of Engraving and Printing to secure United States currency;
(iii) are manufactured and distributed in a highly secure, tightly controlled environment; and
(iv) incorporate additional layers of nonvisible convert security features up to and including forensic capability, as described in subsection (b); or
(B) technologies that have a function of security comparable to that described in subparagraph (A), as determined by the Secretary.
(b) Standards for Packaging.--For the purpose of making it more difficult to counterfeit the packaging of drugs subject to this section, the manufacturers of such drugs shall incorporate the technologies described in subsection (a) into at least 1 additional element of the physical packaging of the drugs, including blister packs, shrink wrap, package labels, package seals, bottles, and boxes.


(As printed in the Congressional Record for the Senate on May 8, 2007.)