I 

108TH CONGRESS 

1ST SESSION H. R. 2652

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

sale of prescription drugs through the Internet. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 26, 2003

Mr. STUPAK 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 sale of prescription drugs through the Internet.

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 ‘‘Internet Pharmacy 

5 Consumer Protection Act’’. 

6 SEC. 2. INTERNET SALES OF PRESCRIPTION DRUGS. 

7 (a) IN GENERAL.—Chapter 5 of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend9 ed by inserting after section 503A the following section: 
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1 ‘‘SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS. 

2 ‘‘(a) IN GENERAL.—A person may not introduce a 

3 prescription drug into interstate commerce or deliver the 

4 prescription drug for introduction into such commerce 

5 pursuant to a sale of the drug by such person if—

6 ‘‘(1) the purchaser of the drug submitted the 

7 purchase order for the drug, or conducted any other 

8 part of the sales transaction for the drug, through 

9 an Internet site; and 

10 ‘‘(2) such site, or any other Internet site used 

11 by such person for purposes of sales of a prescrip12 tion drug, fails to meet each of the requirements 

13 specified in subsection (b) (other than a site or 

14 pages on a site that are not intended to be accessed 

15 by purchasers or prospective purchasers). 

16 ‘‘(b) REQUIREMENTS.—With respect to an Internet 

17 site, the requirements referred to in paragraph (2) of sub18 section (a) for a person to whom such subsection applies 

19 are as follows: 

20 ‘‘(1) The site shall include a page that provides 

21 the following information: 

22 ‘‘(A) The name of such person; the address 

23 of the principal place of business of the person 

24 with respect to sales of prescription drugs 

25 through the Internet; and the telephone number 

26 for such place of business. 
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1 ‘‘(B) Each State in which the person is au2 thorized by law to dispense prescription drugs. 

3 ‘‘(C) The name of each individual who 

4 serves as a pharmacist for purposes of the site, 

5 and each State in which the individual is au6 thorized by law to dispense prescription drugs. 

7 ‘‘(D) If the person provides for medical 

8 consultations through the site for purposes of 

9 providing prescriptions, the name of each indi10 vidual who provides such consultations; each 

11 State in which the individual is licensed or oth12 erwise authorized by law to provide such con13 sultations; and the type or types of health pro14 fessions for which the individual holds such li15 censes or other authorizations. 

16 ‘‘(2) Each other page of the site (if any) shall 

17 include either a link to the page referred to in para18 graph (1) or the information described in such para19 graph. 

20 ‘‘(3) A link to which paragraph (2) applies shall 

21 be clearly visible on the page involved, shall not be 

22 of a size smaller than other links on the page (if 

23 any), and shall include in the caption for the link ei24 ther the word ‘licensing’ or the word ‘licenses’. 
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1 ‘‘(c) PRIMARY ENFORCEMENT AUTHORITY FOR

2 STATES.—

3 ‘‘(1) IN GENERAL.—With respect to the pur4 chase of a prescription drug, if a State has in effect 

5 requirements for Internet sites that are no less 

6 stringent than the requirements established in sub7 section (b) for such sites, and has adequate proce8 dures for the enforcement of the requirements, the 

9 State has primary enforcement responsibility for any 

10 violation involving such a purchase made from with11 in the State. 

12 ‘‘(2) DETERMINATION.—The Secretary shall by 

13 regulation establish a procedure through which a 

14 State can, upon the request of the State, obtain 

15 from the Secretary a determination of whether 

16 under paragraph (1) the State has primary enforce17 ment responsibility. Not later than 180 days after 

18 the date of the enactment of the Internet Pharmacy 

19 Consumer Protection Act, the Secretary shall issue 

20 a proposed rule for purposes of the preceding sen21 tence. 

22 ‘‘(d) DEFINITIONS.—For purposes of this section: 

23 ‘‘(1) The term ‘Internet’ means collectively the 

24 myriad of computer and telecommunications facili25 ties, including equipment and operating software, 
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1 which comprise the interconnected world-wide net2 work of networks that employ the Transmission 

3 Control Protocol/Internet Protocol, or any prede4 cessor or successor protocols to such protocol, to 

5 communicate information of all kinds by wire or 

6 radio. 

7 ‘‘(2) The term ‘link’, with respect to the Inter8 net, means one or more letters, words, numbers, 

9 symbols, or graphic items that appear on a page of 

10 an Internet site for the purpose of serving, when ac11 tivated, as a method for executing an electronic com12 mand—

13 ‘‘(A) to move from viewing one portion of 

14 a page on such site to another portion of the 

15 page; 

16 ‘‘(B) to move from viewing one page on 

17 such site to another page on such site; or 

18 ‘‘(C) to move from viewing a page on one 

19 Internet site to a page on another Internet site. 

20 ‘‘(3) The term ‘page’, with respect to the Inter21 net, means a document or other file accessed at an 

22 Internet site. 

23 ‘‘(4) The term ‘prescription drug’ means a drug 

24 subject to section 503(b). 
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1 ‘‘(5)(A) The terms ‘site’ and ‘address’, with re2 spect to the Internet, mean a specific location on the 

3 Internet that is determined by Internet protocol 

4 numbers. Such term includes the domain name, if 

5 any. 

6 ‘‘(B) The term ‘domain name’ means a method 

7 of representing an Internet address without direct 

8 reference to the Internet Protocol numbers for the 

9 address, including methods that use the designations 

10 ‘.com’, ‘.edu’, ‘.gov’, and ‘.org’. 

11 ‘‘(C) The term ‘Internet Protocol numbers’ in12 cludes any successor protocol for determining a spe13 cific location on the Internet.’’. 

14 (b) INCLUSION AS PROHIBITED ACT.—Section 301 of 

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

16 331) is amended by inserting after paragraph (k) the fol17 lowing: 

18 ‘‘(l) The introduction or delivery for introduction into 

19 interstate commerce of a prescription drug in violation of 

20 section 503B.’’. 

21 SEC. 3. EFFECTIVE DATE. 

22 The amendments made by section 2 take effect upon 

23 the expiration of the 60-day period beginning on the date 

24 of the enactment of this Act, without regard to whether 

25 a final rule to implement such amendments has been pro-
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1 mulgated by the Secretary of Health and Human Services 

2 under section 701(a) of the Federal Food, Drug, and Cos3 metic Act. The preceding sentence may not be construed 

4 as affecting the authority of such Secretary to promulgate 

5 such a final rule.

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