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 Com-
mittee on Ways and Means, and in addition to the Committee on Energy 
and Commerce, for a period to be subsequently determined by the Speak-
er, in each case for consideration of such provisions as fall within the ju-
risdiction 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.
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 ‘‘New Aid for Trust-
worthy, Affordable Drugs Act (NAFTA Drugs Act)’’. 
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SEC. 2. HARMONIZATION OF DRUG LAWS REGARDING IM-
PORTATION INTO NAFTA COUNTRIES FROM 
OTHER NAFTA COUNTRIES. 
Section 803 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 383) is amended by adding at the end the 
following subsection: 
‘‘(d)(1) Consistent with the North American Free 
Trade Agreement approved by the Congress under section 
101(a) of Public Law 103–182 (referred to in this sub-
section as ‘NAFTA’), the United States Trade Represent-
ative shall seek to enter into agreements with other 
NAFTA countries to harmonize regulatory requirements 
for drugs such that drugs approved for commercial dis-
tribution in any NAFTA country may be imported or ex-
ported from any NAFTA country into any NAFTA coun-
try. 
‘‘(2) The United States Trade Representative shall 
carry out this subsection in consultation with the Sec-
retary and the Commissioner of Food and Drugs. 
‘‘(3) The United States Trade Representative may 
enter into a harmonization agreement under paragraph 
(1) only if such Representative determines as follows: 
‘‘(A) That the proposed agreement provides for 
regulatory standards for drugs that are consistent 
with the requirements of this Act. 
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‘‘(B) That the proposed agreement provides 
for—
‘‘(i) the display of a seal on the labeling of 
the drugs involved, whose purpose is to indicate 
that the drugs meet the standards of the har-
monization agreement and may be imported as 
provided in paragraph (1); 
‘‘(ii) uniform standards applicable to the 
display of such a seal in any NAFTA country; 
and 
‘‘(iii) approval of such a seal by the appro-
priate health authority in any NAFTA country 
before the display of the seal in that country, 
for the purpose of ensuring that the seal com-
plies with the uniform standards described in 
clause (ii). 
‘‘(C) That the proposed agreement provides 
that a drug may not be imported into a NAFTA 
country from another NAFTA country unless the la-
beling of the drug bears a seal described in subpara-
graph (B). 
‘‘(D) That the proposed agreement provides for 
a system of unique tracking numbers to indicate—
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‘‘(i) the manufacturer of the drug involved, 
the NAFTA country of origin, and the whole-
sale distributors of the drug; and 
‘‘(ii) in the case of a prescription drug, the 
pharmacy that dispenses the drug. 
‘‘(E) That the proposed agreement provides 
for—
‘‘(i) the placement of a seal described in 
subparagraph (B) on the labeling of a drug only 
by a pharmacy registered in accordance with 
this subparagraph; 
‘‘(ii) registration of pharmacies in each 
NAFTA country by the appropriate health au-
thority in each such country for the purpose of 
authorizing such pharmacies to place a seal de-
scribed in subparagraph (B) on the labeling of 
drugs; and 
‘‘(iii) uniform standards applicable to such 
registration. 
‘‘(F) That the proposed agreement—
‘‘(i) requires drug manufacturers to reim-
burse the Secretary of Health and Human 
Services for benefits derived by such manufac-
turers from research performed by the National 
Institutes of Health; and 
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‘‘(ii) authorizes use of such reimbursement 
to pay the expenses incurred by the Food and 
Drug Administration in approving seals under 
subparagraph (B) and registering pharmacies 
under subparagraph (E). 
‘‘(G) That the proposed agreement prohibits 
any discrimination by any person in the manufac-
ture, distribution, or sale of any drug that bears a 
seal described in subparagraph (B), on the basis of 
a prospective customer’s citizenship or residency in 
a NAFTA country, or on the basis of a request for 
shipment of the drug to any NAFTA country. 
‘‘(4) The authority of the United States Trade Rep-
resentative to enter a harmonization agreement under 
paragraph (1) terminates one year after the date of the 
enactment of New Aid for Trustworthy, Affordable Drugs 
Act (NAFTA Drugs Act). 
‘‘(5) For purposes of this subsection, the term 
‘NAFTA country’ means each of the United States, Can-
ada, and the United Mexican States—
‘‘(A) for such time as NAFTA is in force with 
respect to such country; and
‘‘(B) in the case of each of Canada and the 
United Mexican States, for such time as the United 
States applies NAFTA to such country.’’.
Æ
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