I 
112TH CONGRESS 
1ST SESSION 
H. R. 147 
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 
JANUARY 5, 2011 
Mr. PAUL 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 with 
respect to the importation 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, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Prescription Drug Af-
fordability Act’’. 
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SEC. 2. 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 
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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; 
(2) in subclause (III) of paragraph (2)(A)(i) (as 
redesignated by this subsection), by striking ‘‘para-
graph (4)’’ and inserting ‘‘paragraph (3)’’; and 
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(3) in paragraph (3) (as redesignated by this 
subsection), by striking ‘‘paragraph (3)’’ each place 
such term appears and inserting ‘‘paragraph (2)’’. 
SEC. 3. 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, the Controlled Substances Act, and State laws 
that are applicable to the sale of the drug; and 
‘‘(ii) accurate information regarding compliance 
with this Act, the Controlled Substances 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 
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‘‘(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. 4. 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 2 and 3. 
(b) EFFECTIVE DATE.—The amendments to the Fed-
eral Food, Drug, and Cosmetic Act that are made by sec-
tions 2 and 3 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 required 
in subsection (a) have been promulgated. 
Æ 
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