I

106TH CONGRESS

1ST SESSION H. R. 1885

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.

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘International Prescrip5 tion Drug Parity Act’’.
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1 SEC. 2. FACILITATION OF IMPORTATION OF DRUGS AP2 PROVED BY FOOD AND DRUG ADMINISTRA3 TION.

4 (a) IN GENERAL.—Section 801(d) of the Federal

5 Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is

6 amended—

7 (1) by redesignating paragraphs (3) and (4) as

8 paragraphs (4) and (5), respectively; and

9 (2) by striking ‘‘(d)(1)’’ and all that follows

10 through the end of paragraph (2) and inserting the

11 following:

12 ‘‘(d)(1) If a covered drug (as defined in paragraph

13 (3)) is domestically approved and is manufactured in a

14 State and then exported, or is domestically approved and

15 is for commercial distribution manufactured in a foreign

16 establishment registered under section 510, the manufac17 turer shall, as a condition of maintaining the domestic ap18 proval of the drug, comply with the following:

19 ‘‘(A) For each shipment of the drug that is

20 manufactured in compliance with current good man21 ufacturing practice and other standards under sec22 tion 501, the manufacturer shall maintain a record

23 that identifies the shipment and states the fact of

24 such compliance, without regard to whether the ship25 ment is intended for importation into the United

26 States.
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1 ‘‘(B) For each such shipment, the manufacturer

2 shall maintain a record that identifies the shipment

3 and provides the labeling required for the drug pur4 suant to section 501 and pursuant to the application

5 for domestic approval, without regard to whether the

6 shipment is intended for importation into the United

7 States.

8 ‘‘(C) Upon the request of a person who intends

9 to import into the United States drugs from such

10 shipment (and who meets applicable legal require11 ments to be an importer of covered drugs), the man12 ufacturer shall provide to the person a copy of each

13 of the records maintained under subparagraphs (A)

14 and (B) with respect to the shipment.

15 ‘‘(2) For the purpose of facilitating the importation

16 into the United States of covered drugs, the Secretary

17 shall by regulation establish the following criteria:

18 ‘‘(A) Criteria regarding the records required in

19 paragraph (1) and the use of the records to dem20 onstrate the domestic approval of the drugs and

21 compliance of the drugs with sections 501 and 502.

22 ‘‘(B) Such criteria regarding the labeling of the

23 drugs as the Secretary determines to be appropriate.

24 ‘‘(C) Criteria regarding the amount of charges

25 that may be imposed by manufacturers of the drugs
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1 for maintaining and providing the records specified

2 in subparagraph (A).

3 ‘‘(3) For purposes of this subsection:

4 ‘‘(A) The term ‘covered drug’ means a drug

5 that is described in section 503(b) or is composed

6 wholly or partly of insulin.

7 ‘‘(B) The term ‘domestically approved’, with re8 spect to a drug, means a drug for which an applica9 tion is approved under section 505, or as applicable,

10 under section 351 of the Public Health Service Act.

11 The term ‘domestic approval’, with respect to a

12 drug, means approval of an application for a drug

13 under such a section.’’.

14 (b) CONFORMING AMENDMENT.—Section 801(d) of

15 the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

16 381(d)) is amended in paragraph (5) (as redesignated by

17 subsection (a)(1) of this section) by striking ‘‘paragraph

18 (3)’’ each place such term appears and inserting ‘‘para19 graph (4)’’.

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