[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3240 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 3240

 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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            November 5, 1999

   Mr. Gutknecht (for himself, Mr. Foley, Mr. Coburn, and Mr. Paul) 
 introduced the following bill; which was referred to the Committee on 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
 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 1999''.

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.''.
                                 <all>