I 

108TH CONGRESS 

1ST SESSION H. R. 2629

To provide for the importation of drugs into the United States from Canada 

and Mexico, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 26, 2003

Mr. CROWLEY (for himself, Mr. SANDERS, Mr. CASE, Mr. HINCHEY, and Mrs. 

MALONEY) introduced the following bill; which was referred to the Committee on Ways and Means, and in addition to the Committee on Energy 

and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL

To provide for the importation of drugs into the United 

States from Canada and Mexico, and for other purposes.

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 ‘‘New Aid for Trust5 worthy, Affordable Drugs Act (NAFTA Drugs Act)’’. 

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1 SEC. 2. HARMONIZATION OF DRUG LAWS REGARDING IM2 PORTATION INTO NAFTA COUNTRIES FROM 

3 OTHER NAFTA COUNTRIES. 

4 Section 803 of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 383) is amended by adding at the end the 

6 following subsection: 

7 ‘‘(d)(1) Consistent with the North American Free 

8 Trade Agreement approved by the Congress under section 

9 101(a) of Public Law 103–182 (referred to in this sub10 section as ‘NAFTA’), the United States Trade Represent11 ative shall seek to enter into agreements with other 

12 NAFTA countries to harmonize regulatory requirements 

13 for drugs such that drugs approved for commercial dis14 tribution in any NAFTA country may be imported or ex15 ported from any NAFTA country into any NAFTA coun16 try. 

17 ‘‘(2) The United States Trade Representative shall 

18 carry out this subsection in consultation with the Sec19 retary and the Commissioner of Food and Drugs. 

20 ‘‘(3) The United States Trade Representative may 

21 enter into a harmonization agreement under paragraph 

22 (1) only if such Representative determines as follows: 

23 ‘‘(A) That the proposed agreement provides for 

24 regulatory standards for drugs that are consistent 

25 with the requirements of this Act. 

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1 ‘‘(B) That the proposed agreement provides 

2 for—

3 ‘‘(i) the display of a seal on the labeling of 

4 the drugs involved, whose purpose is to indicate 

5 that the drugs meet the standards of the har6 monization agreement and may be imported as 

7 provided in paragraph (1); 

8 ‘‘(ii) uniform standards applicable to the 

9 display of such a seal in any NAFTA country; 

10 and 

11 ‘‘(iii) approval of such a seal by the appro12 priate health authority in any NAFTA country 

13 before the display of the seal in that country, 

14 for the purpose of ensuring that the seal com15 plies with the uniform standards described in 

16 clause (ii). 

17 ‘‘(C) That the proposed agreement provides 

18 that a drug may not be imported into a NAFTA 

19 country from another NAFTA country unless the la20 beling of the drug bears a seal described in subpara21 graph (B). 

22 ‘‘(D) That the proposed agreement provides for 

23 a system of unique tracking numbers to indicate—

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1 ‘‘(i) the manufacturer of the drug involved, 

2 the NAFTA country of origin, and the whole3 sale distributors of the drug; and 

4 ‘‘(ii) in the case of a prescription drug, the 

5 pharmacy that dispenses the drug. 

6 ‘‘(E) That the proposed agreement provides 

7 for—

8 ‘‘(i) the placement of a seal described in 

9 subparagraph (B) on the labeling of a drug only 

10 by a pharmacy registered in accordance with 

11 this subparagraph; 

12 ‘‘(ii) registration of pharmacies in each 

13 NAFTA country by the appropriate health au14 thority in each such country for the purpose of 

15 authorizing such pharmacies to place a seal de16 scribed in subparagraph (B) on the labeling of 

17 drugs; and 

18 ‘‘(iii) uniform standards applicable to such 

19 registration. 

20 ‘‘(F) That the proposed agreement—

21 ‘‘(i) requires drug manufacturers to reim22 burse the Secretary of Health and Human 

23 Services for benefits derived by such manufac24 turers from research performed by the National 

25 Institutes of Health; and 

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1 ‘‘(ii) authorizes use of such reimbursement 

2 to pay the expenses incurred by the Food and 

3 Drug Administration in approving seals under 

4 subparagraph (B) and registering pharmacies 

5 under subparagraph (E). 

6 ‘‘(G) That the proposed agreement prohibits 

7 any discrimination by any person in the manufac8 ture, distribution, or sale of any drug that bears a 

9 seal described in subparagraph (B), on the basis of 

10 a prospective customer’s citizenship or residency in 

11 a NAFTA country, or on the basis of a request for 

12 shipment of the drug to any NAFTA country. 

13 ‘‘(4) The authority of the United States Trade Rep14 resentative to enter a harmonization agreement under 

15 paragraph (1) terminates one year after the date of the 

16 enactment of New Aid for Trustworthy, Affordable Drugs 

17 Act (NAFTA Drugs Act). 

18 ‘‘(5) For purposes of this subsection, the term 

19 ‘NAFTA country’ means each of the United States, Can20 ada, and the United Mexican States—

21 ‘‘(A) for such time as NAFTA is in force with 

22 respect to such country; and 
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1 ‘‘(B) in the case of each of Canada and the 

2 United Mexican States, for such time as the United 

3 States applies NAFTA to such country.’’.

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