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Full Text of this Amendment
At the appropriate place in the amendment, insert the following:
SEC. __. REQUIRED FDA APPROVAL OF DRUGS.
Notwithstanding any other provision of this title (and the amendment made by this title) a prescription drug may only be imported by a pharmacist, wholesaler, or individual under this title (or amendments) if--
(1) such drug complies with section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)(including with respect to being safe and effective for the intended use of the prescription drug) and with sections 501 and 502 of such Act (21 U.S.C. 351 and 352);
(2) the importer of such drug complies with subsections (d)(1) and (e) of section 804 of such Act (21 U.S.C. 384(d)(1) and (e)), as in effect on the day before the date of enactment of this Act; and
(3) the drug or importer of such drug complies with any additional requirements determined by the Secretary of Health and Human Services to be appropriate as a safeguard to protect the public health or as a means to facilitate the importation of prescription drugs.
(As printed in the Congressional Record for the Senate on May 3, 2007.)