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Drug Import Fairness Act of 2000
(Engrossed in House ) 106th CONGRESS 2d Session H. R. 3240 AN ACT To amend the Federal Food, Drug, and Cosmetic Act to clarify certain responsibilities of the Food and Drug Administration with respect to the importation of drugs into the United States. HR 3240 EH 106th CONGRESS 2d Session H. R. 3240 --- AN ACT To amend the Federal Food, Drug, and Cosmetic Act to clarify certain responsibilities of the Food and Drug Administration with respect to the importation of drugs into the United States. 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 `Drug Import Fairness Act of 2000'. SEC. 2. FINDINGS. The Congress finds as follows: (1) Pharmacists, patients, and other persons sometimes have reason to import into the United States drugs that have been approved by the Food and Drug Administration (`FDA'). (2) There have been circumstances in which-- (A) a person seeking to import such a drug has received a notice from FDA that importing the drug violates or may violate the Federal Food, Drug, and Cosmetic Act; and (B) the notice failed to inform the person of the reasons underlying the decision to send the notice. (3) FDA should not send a warning notice regarding the importation of a drug without providing to the person involved a statement of the underlying reasons for the notice. SEC. 3. CLARIFICATION OF CERTAIN RESPONSIBILITIES OF FOOD AND DRUG ADMINISTRATION WITH RESPECT TO IMPORTATION OF DRUGS INTO UNITED STATES. Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following subsection: `(g)(1) With respect to a drug being imported or offered for import into the United States, the Secretary may not send a warning notice to a person (including a pharmacist or wholesale importer) unless the following conditions are met: `(A) The notice specifies, as applicable to the importation of the drug, that the Secretary has made a determination that-- `(i) importation is in violation of section 801(a) because the drug is or appears to be adulterated, misbranded, or in violation of section 505; `(ii) importation is in violation of section 801(a) because the drug is forbidden or restricted in sale in the country in which it was produced or from which it was exported; `(iii) importation by any person other than the manufacturer of the drug is in violation of section 801(d); or `(iv) importation is otherwise in violation of Federal law. `(B) The notice does not specify any provision described in subparagraph (A) that is not applicable to the importation of the drug. `(C) The notice states the reasons underlying such determination by the Secretary, including a brief application to the principal facts involved of the provision of law described in subparagraph (A) that is the basis of the determination by the Secretary. `(2) The term `warning notice', with respect to the importation of a drug, means a communication from the Secretary (written or otherwise) notifying a person, or clearly suggesting to the person, that importing the drug is, or appears to be, a violation of this Act.'. Passed the House of Representatives June 29 (legislative day, June 28), 2000.
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