I
106TH CONGRESS
1ST SESSION
H. R. 1885
To amend the Federal Food, Drug, and Cosmetic Act to provide for facili-
tating the importation into the United States of certain drugs that
have been approved by the Food and Drug Administration.
IN THE HOUSE OF REPRESENTATIVES
MAY 20, 1999
Mr. BERRY (for himself, Mr. SANDERS, Mrs. EMERSON, Mr. ROHRABACHER,
Mr. ABERCROMBIE, and Mr. LEWIS of Georgia) introduced the following
bill; which was referred to the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
provide for facilitating the importation into the United
States of certain drugs that have been approved by the
Food and Drug Administration.
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 ‘‘International Prescrip-
tion Drug Parity Act’’.
SEC. 2. FACILITATION OF IMPORTATION OF DRUGS AP-
PROVED BY FOOD AND DRUG ADMINISTRA-
TION.
(a) IN GENERAL.—Section 801(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is
amended—
(1) by redesignating paragraphs (3) and (4) as
paragraphs (4) and (5), respectively; and
(2) by striking ‘‘(d)(1)’’ and all that follows
through the end of paragraph (2) and inserting the
following:
‘‘(d)(1) If a covered drug (as defined in paragraph
(3)) is domestically approved and is manufactured in a
State and then exported, or is domestically approved and
is for commercial distribution manufactured in a foreign
establishment registered under section 510, the manufac-
turer shall, as a condition of maintaining the domestic ap-
proval of the drug, comply with the following:
‘‘(A) For each shipment of the drug that is
manufactured in compliance with current good man-
ufacturing practice and other standards under sec-
tion 501, the manufacturer shall maintain a record
that identifies the shipment and states the fact of
such compliance, without regard to whether the ship-
ment is intended for importation into the United
States.
‘‘(B) For each such shipment, the manufacturer
shall maintain a record that identifies the shipment
and provides the labeling required for the drug pur-
suant to section 501 and pursuant to the application
for domestic approval, without regard to whether the
shipment is intended for importation into the United
States.
‘‘(C) Upon the request of a person who intends
to import into the United States drugs from such
shipment (and who meets applicable legal require-
ments to be an importer of covered drugs), the man-
ufacturer shall provide to the person a copy of each
of the records maintained under subparagraphs (A)
and (B) with respect to the shipment.
‘‘(2) For the purpose of facilitating the importation
into the United States of covered drugs, the Secretary
shall by regulation establish the following criteria:
‘‘(A) Criteria regarding the records required in
paragraph (1) and the use of the records to dem-
onstrate the domestic approval of the drugs and
compliance of the drugs with sections 501 and 502.
‘‘(B) Such criteria regarding the labeling of the
drugs as the Secretary determines to be appropriate.
‘‘(C) Criteria regarding the amount of charges
that may be imposed by manufacturers of the drugs
for maintaining and providing the records specified
in subparagraph (A).
‘‘(3) For purposes of this subsection:
‘‘(A) The term ‘covered drug’ means a drug
that is described in section 503(b) or is composed
wholly or partly of insulin.
‘‘(B) The term ‘domestically approved’, with re-
spect to a drug, means a drug for which an applica-
tion is approved under section 505, or as applicable,
under section 351 of the Public Health Service Act.
The term ‘domestic approval’, with respect to a
drug, means approval of an application for a drug
under such a section.’’.
(b) CONFORMING AMENDMENT.—Section 801(d) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(d)) is amended in paragraph (5) (as redesignated by
subsection (a)(1) of this section) by striking ‘‘paragraph
(3)’’ each place such term appears and inserting ‘‘para-
graph (4)’’.
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