I 

108TH CONGRESS 

2D SESSION H. R. 3880

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 

MARCH 3, 2004

Mr. TOM DAVIS of Virginia (for himself and Mr. WAXMAN) 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) REQUIREMENTS REGARDING INFORMATION ON

3 INTERNET SITE.—

4 ‘‘(1) IN GENERAL.—A person may not dispense 

5 a prescription drug pursuant to a sale of the drug 

6 by such person if—

7 ‘‘(A) the purchaser of the drug submitted 

8 the purchase order for the drug, or conducted 

9 any other part of the sales transaction for the 

10 drug, through an Internet site; and 

11 ‘‘(B) such site, or any other Internet site 

12 used by such person for purposes of sales of a 

13 prescription drug, fails to meet each of the re14 quirements specified in paragraph (2) (other 

15 than a site or pages on a site that are not in16 tended to be accessed by purchasers or prospec17 tive purchasers or that provide an Internet in18 formation location tool within the meaning of 

19 section 231(e)(5) of the Communications Act of 

20 1934 (47 U.S.C. 231(e)(5)). 

21 ‘‘(2) REQUIREMENTS.—With respect to an 

22 Internet site, the requirements referred to in sub23 paragraph (B) of paragraph (1) for a person to 

24 whom such paragraph applies are as follows: 
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1 ‘‘(A) Each page of the site shall include ei2 ther the following information or a link to a 

3 page that provides the following information: 

4 ‘‘(i) The name of such person; the ad5 dress of the principal place of business of 

6 the person with respect to sales of pre7 scription drugs through the Internet; and 

8 the telephone number for such place of 

9 business. 

10 ‘‘(ii) Each State in which the person 

11 is authorized by law to dispense prescrip12 tion drugs. 

13 ‘‘(iii) The name of each individual 

14 who serves as a pharmacist for purposes of 

15 the site, and each State in which the indi16 vidual is authorized by law to dispense pre17 scription drugs. 

18 ‘‘(iv) If the person provides for med19 ical consultations through the site for pur20 poses of providing prescriptions, the name 

21 of each individual who provides such con22 sultations; each State in which the indi23 vidual is licensed or otherwise authorized 

24 by law to provide such consultations or 

25 practice medicine; and the type or types of 
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1 health professions for which the individual 

2 holds such licenses or other authorizations. 

3 ‘‘(B) A link to which paragraph (1) applies 

4 shall be displayed in a clear and prominent 

5 place and manner, and shall include in the cap6 tion for the link the words ‘licensing and con7 tact information’. 

8 ‘‘(b) INTERNET SALES WITHOUT APPROPRIATE

9 MEDICAL RELATIONSHIPS.—

10 ‘‘(1) IN GENERAL.—A person may not dispense 

11 a prescription drug, or sell such a drug, if—

12 ‘‘(A) for purposes of such dispensing or 

13 sale, the purchaser communicated with the per14 son through the Internet; 

15 ‘‘(B) the patient for whom the drug was 

16 dispensed or purchased did not, when such 

17 communications began, have a prescription for 

18 the drug that is valid in the United States; 

19 ‘‘(C) pursuant to such communications, the 

20 person provided for the involvement of a practi21 tioner, or an individual represented by the per22 son as a practitioner, and the practitioner or 

23 such individual issued a prescription for the 

24 drug that was purchased; 
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1 ‘‘(D) the person knew, or had reason to 

2 know, that the practitioner or the individual re3 ferred to in subparagraph (C) did not, when 

4 issuing the prescription, have a qualifying med5 ical relationship with the patient; and 

6 ‘‘(E) the person received payment for the 

7 dispensing or sale of the drug. 

8 For purposes of subparagraph (E), payment is re9 ceived if money or other other valuable consideration 

10 is received. 

11 ‘‘(2) QUALIFYING MEDICAL RELATIONSHIP.—

12 ‘‘(A) IN GENERAL.—With respect to 

13 issuing a prescription for a drug for a patient, 

14 a practitioner has a qualifying medical relation15 ship with the patient for purposes of this sec16 tion if at least one in-person medical evaluation 

17 of the patient has been conducted by the practi18 tioner. 

19 ‘‘(B) IN-PERSON MEDICAL EVALUATION.—

20 A medical evaluation by a practitioner is an in21 person medical evaluation for purposes of this 

22 section if the practitioner is in the physical 

23 presence of the patient as part of conducting 

24 the evaluation, without regard to whether por-
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1 tions of the evaluation are conducted by other 

2 health professionals. 

3 ‘‘(3) RULES OF CONSTRUCTION.—

4 ‘‘(A) INDIVIDUALS REPRESENTED AS

5 PRACTITIONERS.—A person who is not a practi6 tioner (as defined in subsection (d)(2)) lacks 

7 legal capacity under this section to have a 

8 qualifying medical relationship with any patient. 

9 ‘‘(B) APPLICABILITY OF REQUIRE10 MENTS.—Paragraph (1) may not be construed 

11 as having any applicability beyond this section, 

12 and does not affect any State law, or interpre13 tation of State law, concerning the practice of 

14 medicine. 

15 ‘‘(C) STANDARD PRACTICE OF PHAR16 MACY.—Paragraph (1) may not be construed as 

17 prohibiting any conduct that is a standard prac18 tice in the practice of pharmacy. 

19 ‘‘(c) ACTIONS BY STATES.—

20 ‘‘(1) IN GENERAL.—Whenever an attorney gen21 eral of any State has reason to believe that the in22 terests of the residents of that State have been or 

23 are being threatened or adversely affected because 

24 any person has engaged or is engaging in a pattern 

25 or practice that violates section 301(l), the State 
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1 may bring a civil action on behalf of its residents in 

2 an appropriate district court of the United States to 

3 enjoin such practice, to enforce compliance with such 

4 section (including a nationwide injunction), to obtain 

5 damages, restitution, or other compensation on be6 half of residents of such State, to obtain reasonable 

7 attorneys fees and costs if the State prevails in the 

8 civil action, or to obtain such further and other relief 

9 as the court may deem appropriate. 

10 ‘‘(2) NOTICE.—The State shall serve prior writ11 ten notice of any civil action under paragraph (1) or 

12 (5)(B) upon the Secretary and provide the Secretary 

13 with a copy of its complaint, except that if it is not 

14 feasible for the State to provide such prior notice, 

15 the State shall serve such notice immediately upon 

16 instituting such action. Upon receiving a notice re17 specting a civil action, the Secretary shall have the 

18 right—

19 ‘‘(A) to intervene in such action; 

20 ‘‘(B) upon so intervening, to be heard on 

21 all matters arising therein; and 

22 ‘‘(C) to file petitions for appeal. 

23 ‘‘(3) CONSTRUCTION.—For purposes of bring24 ing any civil action under paragraph (1), nothing in 

25 this chapter shall prevent an attorney general of a 
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1 State from exercising the powers conferred on the 

2 attorney general by the laws of such State to con3 duct investigations or to administer oaths or affir4 mations or to compel the attendance of witnesses or 

5 the production of documentary and other evidence. 

6 ‘‘(4) VENUE; SERVICE OF PROCESS.—Any civil 

7 action brought under paragraph (1) in a district 

8 court of the United States may be brought in the 

9 district in which the defendant is found, is an inhab10 itant, or transacts business or wherever venue is 

11 proper under section 1391 of title 28, United States 

12 Code. Process in such an action may be served in 

13 any district in which the defendant is an inhabitant 

14 or in which the defendant may be found. 

15 ‘‘(5) ACTIONS BY OTHER STATE OFFICIALS.—

16 ‘‘(A) Nothing contained in this section 

17 shall prohibit an authorized State official from 

18 proceeding in State court on the basis of an al19 leged violation of any civil or criminal statute of 

20 such State. 

21 ‘‘(B) In addition to actions brought by an 

22 attorney general of a State under paragraph 

23 (1), such an action may be brought by officers 

24 of such State who are authorized by the State 
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1 to bring actions in such State on behalf of its 

2 residents. 

3 ‘‘(d) DEFINITIONS.—

4 ‘‘(1) INTERNET-RELATED DEFINITIONS.—For 

5 purposes of this section: 

6 ‘‘(A) The term ‘Internet’ means collectively 

7 the myriad of computer and telecommunications 

8 facilities, including equipment and operating 

9 software, which comprise the interconnected 

10 world-wide network of networks that employ the 

11 transmission control protocol/internet protocol, 

12 or any predecessor or successor protocols to 

13 such protocol, to communicate information of 

14 all kinds by wire or radio. 

15 ‘‘(B) The term ‘link’, with respect to the 

16 Internet, means one or more letters, words, 

17 numbers, symbols, or graphic items that appear 

18 on a page of an Internet site for the purpose 

19 of serving, when activated, as a method for exe20 cuting an electronic command—

21 ‘‘(i) to move from viewing one portion 

22 of a page on such site to another portion 

23 of the page; 
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1 ‘‘(ii) to move from viewing one page 

2 on such site to another page on such site; 

3 or 

4 ‘‘(iii) to move from viewing a page on 

5 one Internet site to a page on another 

6 Internet site. 

7 ‘‘(C) The term ‘page’, with respect to the 

8 Internet, means a document or other file 

9 accessed at an Internet site. 

10 ‘‘(D)(i) The terms ‘site’ and ‘address’, with 

11 respect to the Internet, mean a specific location 

12 on the Internet that is determined by Internet 

13 Protocol numbers. Such term includes the do14 main name, if any. 

15 ‘‘(ii) The term ‘domain name’ means a 

16 method of representing an Internet address 

17 without direct reference to the Internet Protocol 

18 numbers for the address, including methods 

19 that use designations such as ‘.com’, ‘.edu’, 

20 ‘.gov’, ‘.net’, or ‘.org’. 

21 ‘‘(iii) The term ‘Internet Protocol num22 bers’ includes any successor protocol for deter23 mining a specific location on the Internet. 

24 ‘‘(2) OTHER DEFINITIONS.—For purposes of 

25 this section: 
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1 ‘‘(A) The term ‘practitioner’ means a prac2 titioner referred to in section 503(b)(1) with re3 spect to issuing a written or oral prescription. 

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

5 drug that is subject to section 503(b)(1). 

6 ‘‘(C) The term ‘qualifying medical relation7 ship’, with respect to a practitioner and a pa8 tient, has the meaning indicated for such term 

9 in subsection (b). 

10 ‘‘(e) INTERACTIVE COMPUTER SERVICE; ADVER11 TISING.—No provider of an interactive computer service, 

12 as defined in section 230(f)(2) of the Communications Act 

13 of 1934 (47 U.S.C. 230(f)(2)), or of advertising services 

14 shall be liable under this section for dispensing or selling 

15 prescription drugs in violation of this section on account 

16 of another person’s selling or dispensing such drugs, pro17 vided that the provider of the interactive computer service 

18 or of advertising services does not own or exercise cor19 porate control over such person.’’. 

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

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

22 331) is amended by inserting after paragraph (k) the fol23 lowing: 

24 ‘‘(l) The dispensing or selling of a prescription drug 

25 in violation of section 503B.’’. 
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1 (c) INTERNET SALES OF PRESCRIPTION DRUGS; 

2 CONSIDERATION BY SECRETARY OF PRACTICES AND PRO3 CEDURES FOR CERTIFICATION OF LEGITIMATE BUSI4 NESSES.—In carrying out section 503B of the Federal 

5 Food, Drug, and Cosmetic Act (as added by subsection 

6 (a) of this section), the Secretary of Health and Human 

7 Services shall take into consideration the practices and 

8 procedures of public or private entities that certify that 

9 businesses selling prescription drugs through Internet 

10 sites are legitimate businesses, including practices and 

11 procedures regarding disclosure formats and verification 

12 programs. 

13 (d) EFFECTIVE DATE.—The amendments made by 

14 subsections (a) and (b) take effect upon the expiration of 

15 the 60-day period beginning on the date of the enactment 

16 of this Act, without regard to whether a final rule to im17 plement such amendments has been promulgated by the 

18 Secretary of Health and Human Services under section 

19 701(a) of the Federal Food, Drug, and Cosmetic Act. The 

20 preceding sentence may not be construed as affecting the 

21 authority of such Secretary to promulgate such a final 

22 rule. 
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1 SEC. 3. REPORTS REGARDING INTERNET-RELATED VIOLA2 TIONS OF STATE AND FEDERAL LAWS ON DIS3 PENSING OF DRUGS. 

4 (a) IN GENERAL.—The Secretary of Health and 

5 Human Services (referred to in this section as the ‘‘Sec6 retary’’) shall, pursuant to the submission of an applica7 tion meeting the criteria of the Secretary, make an award 

8 of a grant or contract to the National Clearinghouse on 

9 Internet Prescribing (operated by the Federation of State 

10 Medical Boards) for the purpose of—

11 (1) identifying Internet sites that appear to be 

12 in violation of State or Federal laws concerning the 

13 dispensing of drugs; 

14 (2) reporting such sites to State medical licens15 ing boards and State pharmacy licensing boards, 

16 and to the Attorney General and the Secretary, for 

17 further investigation; and 

18 (3) submitting, for each fiscal year for which 

19 the award under this subsection is made, a report to 

20 the Secretary describing investigations undertaken 

21 with respect to violations described in paragraph (1). 

22 (b) AUTHORIZATION OF APPROPRIATIONS.—For the 

23 purpose of carrying out subsection (a), there is authorized 

24 to be appropriated $100,000 for each of the fiscal years 

25 2004 through 2006.

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