I 
108TH CONGRESS 
1ST SESSION 
H. R. 616
To amend the Internal Revenue Code of 1986 with respect to the purchase 
of prescription drugs by individuals who have attained retirement age, 
and to amend the Federal Food, Drug, and Cosmetic Act with respect 
to the importation of prescription drugs and the sale of such drugs 
through Internet sites. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 5, 2003
Mr. PAUL introduced the following bill; which was referred to the Committee 
on Energy and Commerce, and in addition to the Committee on Ways 
and Means, for a period to be subsequently determined by the Speaker, 
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned 
A BILL 
To amend the Internal Revenue Code of 1986 with respect 
to the purchase of prescription drugs by individuals who 
have attained retirement age, and to amend the Federal 
Food, Drug, and Cosmetic Act with respect to the impor-
tation of prescription drugs and the sale of such drugs 
through Internet sites.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years beginning more 
than 1 year after the date of the enactment of this Act. 
TITLE II—AMENDMENTS TO FED-
ERAL FOOD, DRUG, AND COS-
METIC ACT 
SEC. 201. FACILITATION OF IMPORTATION OF DRUGS AP-
PROVED BY FOOD AND DRUG ADMINISTRA-
TION. 
(a) IN GENERAL.—Chapter VIII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 
is amended—
(1) by striking section 804; and 
(2) in section 801(d)—
(A) by striking paragraph (2); and 
(B) by striking ‘‘(d)(1)’’ and all that fol-
lows through the end of paragraph (1) and in-
serting the following: 
‘‘(d)(1)(A) A person who meets applicable legal re-
quirements to be an importer of drugs described in sub-
paragraph (B) may import such a drug (without regard 
to whether the person is a manufacturer of the drug) if 
the person submits to the Secretary an application to im-
port the drug and the Secretary approves the application.
‘‘(B) For purposes of subparagraph (A), the drugs 
described in this subparagraph are drugs that are subject 
to section 503(b)(1) or that are composed wholly or partly 
of insulin. 
‘‘(C) The Secretary shall approve an application 
under subparagraph (A) if the application demonstrates 
that the drug to be imported meets all requirements under 
this Act for the admission of the drug into the United 
States, including demonstrating that—
‘‘(i) an application for the drug has been ap-
proved under section 505, or as applicable, under 
section 351 of the Public Health Service Act; and 
‘‘(ii) the drug is not adulterated or misbranded. 
‘‘(D) Not later than 60 days after the date on which 
an application under subparagraph (A) is submitted to the 
Secretary, the Secretary shall—
‘‘(i) approve the application; or 
‘‘(ii) refuse to approve the application and pro-
vide to the person who submitted the application the 
reason for such refusal. 
‘‘(E) This paragraph may not be construed as affect-
ing any right secured by patent.’’. 
(b) CONFORMING AMENDMENTS.—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 (2) and (3), respectively; and 
(2) in paragraph (3) (as so redesignated) by 
striking ‘‘paragraph (3)’’ each place such term ap-
pears and inserting ‘‘paragraph (2)’’. 
SEC. 202. INTERNET SALES OF PRESCRIPTION DRUGS. 
Section 503(b) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353(b)) is amended by adding at 
the end the following paragraph: 
‘‘(6)(A) With respect to the interstate sale of a pre-
scription drug through an Internet site, the Secretary may 
not with respect to such sale take any action under this 
Act against any of the persons involved if—
‘‘(i) the sale was made in compliance with this 
Act and with State laws that are applicable to the 
sale of the drug; and 
‘‘(ii) accurate information regarding compliance 
with this Act and such State laws is posted on the 
Internet site. 
‘‘(B) For purposes of subparagraph (A), the sale of 
a prescription drug by a person shall be considered to be 
an interstate sale of the drug through an Internet site if—
‘‘(i) the purchaser of the drug submits the pur-
chase order for the drug, or conducts any other part
of the sales transaction for the drug, through an 
Internet site; and 
‘‘(ii) pursuant to such sale, the person intro-
duces the drug into interstate commerce or delivers 
the drug for introduction into such commerce. 
‘‘(C) Subparagraph (A) may not be construed as au-
thorizing the Secretary to enforce any violation of State 
law. 
‘‘(D) For purposes of this paragraph, the term ‘pre-
scription drug’ means a drug that is subject to paragraph 
(1).’’. 
SEC. 203. REGULATIONS OF SECRETARY OF HEALTH AND 
HUMAN SERVICES; EFFECTIVE DATE. 
(a) REGULATIONS.—Before the expiration of the pe-
riod specified in subsection (b), the Secretary of Health 
and Human Services shall promulgate regulations to carry 
out the amendments to the Federal Food, Drug, and Cos-
metic Act that are made by sections 201 and 202. 
(b) EFFECTIVE DATE.—The amendments to the Fed-
eral Food, Drug, and Cosmetic Act that are made by sec-
tions 201 and 202 take effect upon the expiration of the 
one-year period beginning on the date of the enactment 
of this Act, without regard to whether the regulations re-
quired in subsection (a) have been promulgated.
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