II 

109TH CONGRESS 

1ST SESSION S. 399 

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

sale of prescription drugs through the Internet, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 16, 2005 

Mr. COLEMAN (for himself and Mrs. FEINSTEIN) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL

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

respect to the sale of prescription drugs through the 

Internet, and for other purposes.

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’’ or the ‘‘Ryan Haight 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; 

11 ‘‘(B) the person dispenses the drug to the 

12 purchaser by mailing or shipping the drug to 

13 the purchaser; and 

14 ‘‘(C) such site, or any other Internet site 

15 used by such person for purposes of sales of a 

16 prescription drug, fails to meet each of the re17 quirements specified in paragraph (2), other 

18 than a site or pages on a site that— 

19 ‘‘(i) are not intended to be accessed 

20 by purchasers or prospective purchasers; or 

21 ‘‘(ii) provide an Internet information 

22 location tool within the meaning of section 

23 231(e)(5) of the Communications Act of 

24 1934 (47 U.S.C. 231(e)(5)). 

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

26 Internet site, the requirements referred to in sub-
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1 paragraph (C) of paragraph (1) for a person to 

2 whom such paragraph applies are as follows: 

3 ‘‘(A) Each page of the site shall include ei4 ther the following information or a link to a 

5 page that provides the following information: 

6 ‘‘(i) The name of such person. 

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

8 is authorized by law to dispense prescrip9 tion drugs. 

10 ‘‘(iii) The address and telephone num11 ber of each place of business of the person 

12 with respect to sales of prescription drugs 

13 through the Internet, other than a place of 

14 business that does not mail or ship pre15 scription drugs to purchasers. 

16 ‘‘(iv) The name of each individual who 

17 serves as a pharmacist for prescription 

18 drugs that are mailed or shipped pursuant 

19 to the site, and each State in which the in20 dividual is authorized by law to dispense 

21 prescription drugs. 

22 ‘‘(v) If the person provides for medical 

23 consultations through the site for purposes 

24 of providing prescriptions, the name of 

25 each individual who provides such con-
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1 sultations; each State in which the indi2 vidual is licensed or otherwise authorized 

3 by law to provide such consultations or 

4 practice medicine; and the type or types of 

5 health professions for which the individual 

6 holds such licenses or other authorizations. 

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

8 shall be displayed in a clear and prominent 

9 place and manner, and shall include in the cap10 tion for the link the words ‘licensing and con11 tact information’. 

12 ‘‘(b) INTERNET SALES WITHOUT APPROPRIATE

13 MEDICAL RELATIONSHIPS.— 

14 ‘‘(1) IN GENERAL.—Except as provided in para15 graph (2), a person may not dispense a prescription 

16 drug, or sell such a drug, if— 

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

18 sale, the purchaser communicated with the per19 son through the Internet; 

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

21 dispensed or purchased did not, when such 

22 communications began, have a prescription for 

23 the drug that is valid in the United States; 

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

25 person provided for the involvement of a practi-
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1 tioner, or an individual represented by the per2 son as a practitioner, and the practitioner or 

3 such individual issued a prescription for the 

4 drug that was purchased; 

5 ‘‘(D) the person knew, or had reason to 

6 know, that the practitioner or the individual re7 ferred to in subparagraph (C) did not, when 

8 issuing the prescription, have a qualifying med9 ical relationship with the patient; and 

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

11 dispensing or sale of the drug. 

12 For purposes of subparagraph (E), payment is re13 ceived if money or other valuable consideration is re14 ceived. 

15 ‘‘(2) EXCEPTIONS.—Paragraph (1) does not 

16 apply to— 

17 ‘‘(A) the dispensing or selling of a pre18 scription drug pursuant to telemedicine prac19 tices sponsored by— 

20 ‘‘(i) a hospital that has in effect a 

21 provider agreement under title XVIII of 

22 the Social Security Act (relating to the 

23 Medicare program); or 

24 ‘‘(ii) a group practice that has not 

25 fewer than 100 physicians who have in ef-
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1 fect provider agreements under such title; 

2 or 

3 ‘‘(B) the dispensing or selling of a pre4 scription drug pursuant to practices that pro5 mote the public health, as determined by the 

6 Secretary by regulation. 

7 ‘‘(3) QUALIFYING MEDICAL RELATIONSHIP.— 

8 ‘‘(A) IN GENERAL.—With respect to 

9 issuing a prescription for a drug for a patient, 

10 a practitioner has a qualifying medical relation11 ship with the patient for purposes of this sec12 tion if— 

13 ‘‘(i) at least one in-person medical 

14 evaluation of the patient has been con15 ducted by the practitioner; or 

16 ‘‘(ii) the practitioner conducts a med17 ical evaluation of the patient as a covering 

18 practitioner. 

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 ‘‘(C) COVERING PRACTITIONER.—With re4 spect to a patient, a practitioner is a covering 

5 practitioner for purposes of this section if the 

6 practitioner conducts a medical evaluation of 

7 the patient at the request of a practitioner who 

8 has conducted at least one in-person medical 

9 evaluation of the patient and is temporarily un10 available to conduct the evaluation of the pa11 tient. A practitioner is a covering practitioner 

12 without regard to whether the practitioner has 

13 conducted any in-person medical evaluation of 

14 the patient involved. 

15 ‘‘(4) RULES OF CONSTRUCTION.— 

16 ‘‘(A) INDIVIDUALS REPRESENTED AS

17 PRACTITIONERS.—A person who is not a practi18 tioner (as defined in subsection (d)(1)) lacks 

19 legal capacity under this section to have a 

20 qualifying medical relationship with any patient. 

21 ‘‘(B) STANDARD PRACTICE OF PHAR22 MACY.—Paragraph (1) may not be construed as 

23 prohibiting any conduct that is a standard prac24 tice in the practice of pharmacy. 
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1 ‘‘(C) APPLICABILITY OF REQUIRE2 MENTS.—Paragraph (3) may not be construed 

3 as having any applicability beyond this section, 

4 and does not affect any State law, or interpre5 tation of State law, concerning the practice of 

6 medicine. 

7 ‘‘(c) ACTIONS BY STATES.— 

8 ‘‘(1) IN GENERAL.—Whenever an attorney gen9 eral of any State has reason to believe that the in10 terests of the residents of that State have been or 

11 are being threatened or adversely affected because 

12 any person has engaged or is engaging in a pattern 

13 or practice that violates section 301(l), the State 

14 may bring a civil action on behalf of its residents in 

15 an appropriate district court of the United States to 

16 enjoin such practice, to enforce compliance with such 

17 section (including a nationwide injunction), to obtain 

18 damages, restitution, or other compensation on be19 half of residents of such State, to obtain reasonable 

20 attorneys fees and costs if the State prevails in the 

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

22 as the court may deem appropriate. 

23 ‘‘(2) NOTICE.—The State shall serve prior writ24 ten notice of any civil action under paragraph (1) or 

25 (5)(B) upon the Secretary and provide the Secretary 
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1 with a copy of its complaint, except that if it is not 

2 feasible for the State to provide such prior notice, 

3 the State shall serve such notice immediately upon 

4 instituting such action. Upon receiving a notice re5 specting a civil action, the Secretary shall have the 

6 right— 

7 ‘‘(A) to intervene in such action; 

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

9 all matters arising therein; and 

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

11 ‘‘(3) CONSTRUCTION.—For purposes of bring12 ing any civil action under paragraph (1), nothing in 

13 this chapter shall prevent an attorney general of a 

14 State from exercising the powers conferred on the 

15 attorney general by the laws of such State to con16 duct investigations or to administer oaths or affir17 mations or to compel the attendance of witnesses or 

18 the production of documentary and other evidence. 

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

20 action brought under paragraph (1) in a district 

21 court of the United States may be brought in the 

22 district in which the defendant is found, is an inhab23 itant, or transacts business or wherever venue is 

24 proper under section 1391 of title 28, United States 

25 Code. Process in such an action may be served in 
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1 any district in which the defendant is an inhabitant 

2 or in which the defendant may be found. 

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

4 ‘‘(A) Nothing contained in this section 

5 shall prohibit an authorized State official from 

6 proceeding in State court on the basis of an al7 leged violation of any civil or criminal statute of 

8 such State. 

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

10 attorney general of a State under paragraph 

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

12 of such State who are authorized by the State 

13 to bring actions in such State on behalf of its 

14 residents. 

15 ‘‘(d) GENERAL DEFINITIONS.—For purposes of this 

16 section: 

17 ‘‘(1) The term ‘practitioner’ means a practi18 tioner referred to in section 503(b)(1) with respect 

19 to issuing a written or oral prescription. 

20 ‘‘(2) The term ‘prescription drug’ means a drug 

21 that is subject to section 503(b)(1). 

22 ‘‘(3) The term ‘qualifying medical relationship’, 

23 with respect to a practitioner and a patient, has the 

24 meaning indicated for such term in subsection (b). 

25 ‘‘(e) INTERNET-RELATED DEFINITIONS.— 
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1 ‘‘(1) IN GENERAL.—For purposes of this sec2 tion: 

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

4 the myriad of computer and telecommunications 

5 facilities, including equipment and operating 

6 software, which comprise the interconnected 

7 world-wide network of networks that employ the 

8 transmission control protocol/internet protocol, 

9 or any predecessor or successor protocols to 

10 such protocol, to communicate information of 

11 all kinds by wire or radio. 

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

13 Internet, means one or more letters, words, 

14 numbers, symbols, or graphic items that appear 

15 on a page of an Internet site for the purpose 

16 of serving, when activated, as a method for exe17 cuting an electronic command— 

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

19 of a page on such site to another portion 

20 of the page; 

21 ‘‘(ii) to move from viewing one page 

22 on such site to another page on such site; 

23 or 
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1 ‘‘(iii) to move from viewing a page on 

2 one Internet site to a page on another 

3 Internet site. 

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

5 Internet, means a document or other file 

6 accessed at an Internet site. 

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

8 respect to the Internet, mean a specific location 

9 on the Internet that is determined by Internet 

10 Protocol numbers. Such term includes the do11 main name, if any. 

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

13 method of representing an Internet address 

14 without direct reference to the Internet Protocol 

15 numbers for the address, including methods 

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

17 ‘.gov’, ‘.net’, or ‘.org’. 

18 ‘‘(iii) The term ‘Internet Protocol num19 bers’ includes any successor protocol for deter20 mining a specific location on the Internet. 

21 ‘‘(2) AUTHORITY OF SECRETARY.—The Sec22 retary may by regulation modify any definition 

23 under paragraph (1) to take into account changes in 

24 technology. 
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1 ‘‘(f) INTERACTIVE COMPUTER SERVICE; ADVER2 TISING.—No provider of an interactive computer service, 

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

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

5 shall be liable under this section for dispensing or selling 

6 prescription drugs in violation of this section on account 

7 of another person’s selling or dispensing such drugs, pro8 vided that the provider of the interactive computer service 

9 or of advertising services does not own or exercise cor10 porate control over such person.’’. 

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

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

13 331) is amended by inserting after paragraph (k) the fol14 lowing: 

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

16 in violation of section 503B.’’. 

17 (c) INTERNET SALES OF PRESCRIPTION DRUGS; 

18 CONSIDERATION BY SECRETARY OF PRACTICES AND PRO19 CEDURES FOR CERTIFICATION OF LEGITIMATE BUSI20 NESSES.—In carrying out section 503B of the Federal 

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

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

23 Services shall take into consideration the practices and 

24 procedures of public or private entities that certify that 

25 businesses selling prescription drugs through Internet 
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1 sites are legitimate businesses, including practices and 

2 procedures regarding disclosure formats and verification 

3 programs. 

4 (d) REPORTS REGARDING INTERNET-RELATED VIO5 LATIONS OF STATE AND FEDERAL LAWS ON DISPENSING

6 OF DRUGS.— 

7 (1) IN GENERAL.—The Secretary of Health and 

8 Human Services (referred to in this subsection as 

9 the ‘‘Secretary’’) shall, pursuant to the submission 

10 of an application meeting the criteria of the Sec11 retary, make an award of a grant or contract to the 

12 National Clearinghouse on Internet Prescribing (op13 erated by the Federation of State Medical Boards) 

14 for the purpose of— 

15 (A) identifying Internet sites that appear 

16 to be in violation of State or Federal laws con17 cerning the dispensing of drugs; 

18 (B) reporting such sites to State medical 

19 licensing boards and State pharmacy licensing 

20 boards, and to the Attorney General and the 

21 Secretary, for further investigation; and 

22 (C) submitting, for each fiscal year for 

23 which the award under this subsection is made, 

24 a report to the Secretary describing investiga-
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1 tions undertaken with respect to violations de2 scribed in subparagraph (A). 

3 (2) AUTHORIZATION OF APPROPRIATIONS.—For 

4 the purpose of carrying out paragraph (1), there is 

5 authorized to be appropriated $100,000 for each of 

6 the fiscal years 2005 through 2007. 

7 (e) EFFECTIVE DATE.—The amendments made by 

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

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

10 of this Act, without regard to whether a final rule to im11 plement such amendments has been promulgated by the 

12 Secretary of Health and Human Services under section 

13 701(a) of the Federal Food, Drug, and Cosmetic Act. The 

14 preceding sentence may not be construed as affecting the 

15 authority of such Secretary to promulgate such a final 

16 rule.

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