I 
108TH CONGRESS 
2D SESSION 
H. R. 4790 
To amend the Federal Food, Drug, and Cosmetic Act to authorize the 
importation of prescription drugs from Canada and certain other coun-
tries, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 9, 2004 
Mr. JOHN introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
authorize the importation of prescription drugs from 
Canada and certain other countries, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Drug Importation Promotion and Safety Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Importation of prescription drugs; Office of Drug Importation Pro-
motion and Safety; other general provisions.
Sec. 3. Commercial importation. 
Sec. 4. Personal importation; Internet pharmacies. 
Sec. 5. Personal importation; entering United States in possession of prescrip-
tion drugs; compassionate use. 
Sec. 6. Particular products; suspension of authority for importation. 
Sec. 7. Registration of importation facilities. 
Sec. 8. Enforcement; regulations; effective dates. 
Sec. 9. Licensing of Internet pharmacies. 
Sec. 10. Chain of custody of prescription drugs; network for notifications re-
garding counterfeit drugs. 
SEC. 2. IMPORTATION OF PRESCRIPTION DRUGS; OFFICE 
OF DRUG IMPORTATION PROMOTION AND 
SAFETY; OTHER GENERAL PROVISIONS. 
Chapter VIII of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 381 et seq.) is amended— 
(1) by inserting after the chapter heading the 
following: 
‘‘Subchapter A—General Provisions’’; and 
(2) by adding at the end the following: 
‘‘Subchapter B—Importation of Prescription 
Drugs 
‘‘SEC. 811. GENERAL PROVISIONS. 
‘‘(a) OFFICE OF DRUG IMPORTATION PROMOTION 
AND SAFETY.—There is established within the Office of 
the Commissioner of Food and Drugs an office to be 
known as the Office of Drug Importation Promotion and 
Safety, which shall be headed by an Associate Commis-
sioner appointed by the Commissioner. The Commissioner 
of Food and Drugs shall carry out this subchapter acting 
through such Associate Commissioner.
‘‘(b) ANNUAL REPORT.—The Secretary shall annu-
ally submit to the Congress a report on activities carried 
out under this subchapter, including a determination by 
the Secretary of whether prescription drugs imported 
under this subchapter are safe and effective. 
‘‘(c) DEFINITIONS.—For purposes of this subchapter: 
‘‘(1) DRUG IMPORTATION FACILITY.—The term 
‘drug importation facility’ means a person, other 
than an individual importing a prescription drug 
under section 814, located outside the United States 
(other than a transporter) that engages in the dis-
tribution or dispensing of a prescription drug that is 
imported or offered for importation into the United 
States. 
‘‘(2) INTERNET PHARMACY.—The term ‘Inter-
net pharmacy’ means a person, other than an indi-
vidual importing a prescription drug under section 
814, that offers to dispense in the United States a 
prescription drug through an Internet website in 
interstate commerce, regardless of whether the phys-
ical location of the principal place of business of the 
Internet pharmacy is in the United States or in an-
other country. 
‘‘(3) PHARMACY.—The term ‘pharmacy’ means 
a person, other than an individual importing a pre-