I
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) in-
troduced the following bill; which was referred to the Committee on Com-
merce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
clarify certain responsibilities of the Food and Drug Ad-
ministration with respect to the importation of drugs
into the United States.
Be it enacted by the Senate and House of Representa-
tives 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 re-
garding 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 RE-
SPECT 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 of-
fered for import into the United States, the Secretary may
not send a warning notice to a person (including a phar-
macist or wholesale importer) unless the following condi-
tions 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 sec-
tion 505;
‘‘(ii) importation is in violation of section
801(a) because the drug is forbidden or re-
stricted 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.’’.
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