Page:United States Statutes at Large Volume 114 Part 2.djvu/854

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114 STAT. 1549A-40 PUBLIC LAW 106-387—APPENDIX "(aa) The importation of a covered product in violation of section 804, the falsification of any record required to be maintained or provided to the Secretary under such section, or any other violation of regulations under such section.". (2) ENHANCED PENALTIES. —Section 303(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(b)) is amended by adding at the end the following: "(6) Notwithstanding subsection (a), any person who is a manufacturer or importer of a covered product pursuant to section 804(a) and knowingly fails to comply with a requirement of section 804(e) that is applicable to such manufacturer or importer, respectively, shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.". (e) For an additional amount for "Salaries and expenses". Food and Drug Administration, $23,000,000, solely to carry out the "Medicine Equity and Drug Safety Act of 2000", to be available only upon submission of an official budget request and justification for such amount by the President to the Congress. SEC. 746. (a) SHORT TITLE. — This section may be cited as the "Prescription Drug Import Fairness Act of 2000". (b) FINDINGS.— The Congress finds as follows: (1) Patients and their families 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) an individual 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 individual 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 individual involved a statement of the underlying reasons for the notice. (c) CLARIFICATION OF CERTAIN RESPONSIBILITIES OF FOOD AND DRUG ADMINISTRATION WITH RESPECT TO IMPORTATION OF PRESCRIPTION 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 prescription drug being imported or offered for import into the United States, the Secretary, in the case of an individual who is not in the business of such importations, may not send a warning notice to the individual 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 or appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported; "(iii) importation is or appears to be in violation of section 801(d)(1); or