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. 

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 ‘‘Prescription Drug Af5 fordability Act’’. 


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1 SEC. 2. FACILITATION OF IMPORTATION OF DRUGS AP2 PROVED BY FOOD AND DRUG ADMINISTRA3 TION. 

4 (a) IN GENERAL.—Chapter VIII of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 

6 is amended— 

7 (1) by striking section 804; and 

8 (2) in section 801(d)— 

9 (A) by striking paragraph (2); and 

10 (B) by striking ‘‘(d)(1)’’ and all that fol11 lows through the end of paragraph (1) and in12 serting the following: 

13 ‘‘(d)(1)(A) A person who meets applicable legal re14 quirements to be an importer of drugs described in sub15 paragraph (B) may import such a drug (without regard 

16 to whether the person is a manufacturer of the drug) if 

17 the person submits to the Secretary an application to im18 port the drug and the Secretary approves the application. 

19 ‘‘(B) For purposes of subparagraph (A), the drugs 

20 described in this subparagraph are drugs that are subject 

21 to section 503(b)(1) or that are composed wholly or partly 

22 of insulin. 

23 ‘‘(C) The Secretary shall approve an application 

24 under subparagraph (A) if the application demonstrates 

25 that the drug to be imported meets all requirements under 


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1 this Act for the admission of the drug into the United 

2 States, including demonstrating that— 

3 ‘‘(i) an application for the drug has been ap4 proved under section 505, or as applicable, under 

5 section 351 of the Public Health Service Act; and 

6 ‘‘(ii) the drug is not adulterated or misbranded. 

7 ‘‘(D) Not later than 60 days after the date on which 

8 an application under subparagraph (A) is submitted to the 

9 Secretary, the Secretary shall— 

10 ‘‘(i) approve the application; or 

11 ‘‘(ii) refuse to approve the application and pro12 vide to the person who submitted the application the 

13 reason for such refusal. 

14 ‘‘(E) This paragraph may not be construed as affect15 ing any right secured by patent.’’. 

16 (b) CONFORMING AMENDMENTS.—Section 801(d) of 

17 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

18 381(d)) is amended— 

19 (1) by redesignating paragraphs (3) and (4) as 

20 paragraphs (2) and (3), respectively; 

21 (2) in subclause (III) of paragraph (2)(A)(i) (as 

22 redesignated by this subsection), by striking ‘‘para23 graph (4)’’ and inserting ‘‘paragraph (3)’’; and 


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1 (3) in paragraph (3) (as redesignated by this 

2 subsection), by striking ‘‘paragraph (3)’’ each place 

3 such term appears and inserting ‘‘paragraph (2)’’. 

4 SEC. 3. INTERNET SALES OF PRESCRIPTION DRUGS. 

5 Section 503(b) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 353(b)) is amended by adding at 

7 the end the following paragraph: 

8 ‘‘(6)(A) With respect to the interstate sale of a pre9 scription drug through an Internet site, the Secretary may 

10 not with respect to such sale take any action under this 

11 Act against any of the persons involved if— 

12 ‘‘(i) the sale was made in compliance with this 

13 Act, the Controlled Substances Act, and State laws 

14 that are applicable to the sale of the drug; and 

15 ‘‘(ii) accurate information regarding compliance 

16 with this Act, the Controlled Substances Act, and 

17 such State laws is posted on the Internet site. 

18 ‘‘(B) For purposes of subparagraph (A), the sale of 

19 a prescription drug by a person shall be considered to be 

20 an interstate sale of the drug through an Internet site if— 

21 ‘‘(i) the purchaser of the drug submits the pur22 chase order for the drug, or conducts any other part 

23 of the sales transaction for the drug, through an 

24 Internet site; and 


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1 ‘‘(ii) pursuant to such sale, the person intro2 duces the drug into interstate commerce or delivers 

3 the drug for introduction into such commerce. 

4 ‘‘(C) Subparagraph (A) may not be construed as au5 thorizing the Secretary to enforce any violation of State 

6 law. 

7 ‘‘(D) For purposes of this paragraph, the term ‘pre8 scription drug’ means a drug that is subject to paragraph 

9 (1).’’. 

10 SEC. 4. REGULATIONS OF SECRETARY OF HEALTH AND 

11 HUMAN SERVICES; EFFECTIVE DATE. 

12 (a) REGULATIONS.—Before the expiration of the pe13 riod specified in subsection (b), the Secretary of Health 

14 and Human Services shall promulgate regulations to carry 

15 out the amendments to the Federal Food, Drug, and Cos16 metic Act that are made by sections 2 and 3. 

17 (b) EFFECTIVE DATE.—The amendments to the Fed18 eral Food, Drug, and Cosmetic Act that are made by sec19 tions 2 and 3 take effect upon the expiration of the one20 year period beginning on the date of the enactment of this 

21 Act, without regard to whether the regulations required 

22 in subsection (a) have been promulgated. 

Æ 


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