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Full Text of this Amendment

SA 1036. Mr. CORKER submitted an amendment intended to be proposed to amendment SA 990 submitted by Mr. Dorgan (for himself, Ms. Snowe, Mr. Grassley, Mr. McCain, Ms. Stabenow, Mr. Nelson of Florida, Mr. Pryor, Mr. Sanders, Mr. Whitehouse, and Mrs. McCaskill) 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:

On page 88 of the amendment, strike lines 5 through 7 and insert the following:
``(B) the packaging, repackaging, labeling, relabeling, or distribution of a prescription drug.
``(o) Prohibition on Commingling.--
``(1) IN GENERAL.--A registered importer shall not commingle a prescription drug imported into the United States under this section with another prescription drug unless such other prescription drug is imported from a permitted country.
``(2) LABEL.--A registered importer (including an Internet pharmacy) that dispenses a prescription drug imported from a permitted country shall affix on each dispensed container of the prescription drug the label required under paragraph (3), unless such a label is already affixed to the container.
``(3) REQUIREMENTS.--Each prescription drug imported under this section shall be in a container that bears a label stating, in prominent and conspicuous type--
``(A) the lot number of the prescription drug;
``(B) the name, address, and phone number of the exporter of the drug, regardless of whether the exporter is registered;
``(C) the following statement: `This drug has been imported from __XXXX.' with the name of the permitted country from which the prescription drug has imported in the blank space;

``(D) a unique identifier code provided by the Secretary that modifies the national drug code of the prescription drug to indicate that the drug has been imported;
``(E) a statement that discloses the originating country of the drug; and
``(F) that the container complies with any other applicable requirement of this Act.''.



(As printed in the Congressional Record for the Senate on May 3, 2007.)