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.
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 ‘‘Internet Pharmacy 
Consumer Protection Act’’. 
SEC. 2. INTERNET SALES OF PRESCRIPTION DRUGS. 
(a) IN GENERAL.—Chapter 5 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 503A the following section:
‘‘SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS. 
‘‘(a) REQUIREMENTS REGARDING INFORMATION ON 
INTERNET SITE.—
‘‘(1) IN GENERAL.—A person may not dispense 
a prescription drug pursuant to a sale of the drug 
by such person if—
‘‘(A) the purchaser of the drug submitted 
the purchase order for the drug, or conducted 
any other part of the sales transaction for the 
drug, through an Internet site; and 
‘‘(B) such site, or any other Internet site 
used by such person for purposes of sales of a 
prescription drug, fails to meet each of the re-
quirements specified in paragraph (2) (other 
than a site or pages on a site that are not in-
tended to be accessed by purchasers or prospec-
tive purchasers or that provide an Internet in-
formation location tool within the meaning of 
section 231(e)(5) of the Communications Act of 
1934 (47 U.S.C. 231(e)(5)). 
‘‘(2) REQUIREMENTS.—With respect to an 
Internet site, the requirements referred to in sub-
paragraph (B) of paragraph (1) for a person to 
whom such paragraph applies are as follows:
‘‘(A) Each page of the site shall include ei-
ther the following information or a link to a 
page that provides the following information: 
‘‘(i) The name of such person; the ad-
dress of the principal place of business of 
the person with respect to sales of pre-
scription drugs through the Internet; and 
the telephone number for such place of 
business. 
‘‘(ii) Each State in which the person 
is authorized by law to dispense prescrip-
tion drugs. 
‘‘(iii) The name of each individual 
who serves as a pharmacist for purposes of 
the site, and each State in which the indi-
vidual is authorized by law to dispense pre-
scription drugs. 
‘‘(iv) If the person provides for med-
ical consultations through the site for pur-
poses of providing prescriptions, the name 
of each individual who provides such con-
sultations; each State in which the indi-
vidual is licensed or otherwise authorized 
by law to provide such consultations or 
practice medicine; and the type or types of
health professions for which the individual 
holds such licenses or other authorizations. 
‘‘(B) A link to which paragraph (1) applies 
shall be displayed in a clear and prominent 
place and manner, and shall include in the cap-
tion for the link the words ‘licensing and con-
tact information’. 
‘‘(b) INTERNET
SALES
WITHOUT
APPROPRIATE 
MEDICAL RELATIONSHIPS.—
‘‘(1) IN GENERAL.—A person may not dispense 
a prescription drug, or sell such a drug, if—
‘‘(A) for purposes of such dispensing or 
sale, the purchaser communicated with the per-
son through the Internet; 
‘‘(B) the patient for whom the drug was 
dispensed or purchased did not, when such 
communications began, have a prescription for 
the drug that is valid in the United States; 
‘‘(C) pursuant to such communications, the 
person provided for the involvement of a practi-
tioner, or an individual represented by the per-
son as a practitioner, and the practitioner or 
such individual issued a prescription for the 
drug that was purchased;
‘‘(D) the person knew, or had reason to 
know, that the practitioner or the individual re-
ferred to in subparagraph (C) did not, when 
issuing the prescription, have a qualifying med-
ical relationship with the patient; and 
‘‘(E) the person received payment for the 
dispensing or sale of the drug. 
For purposes of subparagraph (E), payment is re-
ceived if money or other other valuable consideration 
is received. 
‘‘(2) QUALIFYING MEDICAL RELATIONSHIP.—
‘‘(A) 
IN
GENERAL.—With 
respect 
to 
issuing a prescription for a drug for a patient, 
a practitioner has a qualifying medical relation-
ship with the patient for purposes of this sec-
tion if at least one in-person medical evaluation 
of the patient has been conducted by the practi-
tioner. 
‘‘(B) IN-PERSON MEDICAL EVALUATION.—
A medical evaluation by a practitioner is an in-
person medical evaluation for purposes of this 
section if the practitioner is in the physical 
presence of the patient as part of conducting 
the evaluation, without regard to whether por-
tions of the evaluation are conducted by other 
health professionals. 
‘‘(3) RULES OF CONSTRUCTION.—
‘‘(A) 
INDIVIDUALS
REPRESENTED
AS 
PRACTITIONERS.—A person who is not a practi-
tioner (as defined in subsection (d)(2)) lacks 
legal capacity under this section to have a 
qualifying medical relationship with any patient. 
‘‘(B) 
APPLICABILITY
OF
REQUIRE-
MENTS.—Paragraph (1) may not be construed 
as having any applicability beyond this section, 
and does not affect any State law, or interpre-
tation of State law, concerning the practice of 
medicine. 
‘‘(C) STANDARD
PRACTICE
OF
PHAR-
MACY.—Paragraph (1) may not be construed as 
prohibiting any conduct that is a standard prac-
tice in the practice of pharmacy. 
‘‘(c) ACTIONS BY STATES.—
‘‘(1) IN GENERAL.—Whenever an attorney gen-
eral of any State has reason to believe that the in-
terests of the residents of that State have been or 
are being threatened or adversely affected because 
any person has engaged or is engaging in a pattern 
or practice that violates section 301(l), the State
may bring a civil action on behalf of its residents in 
an appropriate district court of the United States to 
enjoin such practice, to enforce compliance with such 
section (including a nationwide injunction), to obtain 
damages, restitution, or other compensation on be-
half of residents of such State, to obtain reasonable 
attorneys fees and costs if the State prevails in the 
civil action, or to obtain such further and other relief 
as the court may deem appropriate. 
‘‘(2) NOTICE.—The State shall serve prior writ-
ten notice of any civil action under paragraph (1) or 
(5)(B) upon the Secretary and provide the Secretary 
with a copy of its complaint, except that if it is not 
feasible for the State to provide such prior notice, 
the State shall serve such notice immediately upon 
instituting such action. Upon receiving a notice re-
specting a civil action, the Secretary shall have the 
right—
‘‘(A) to intervene in such action; 
‘‘(B) upon so intervening, to be heard on 
all matters arising therein; and 
‘‘(C) to file petitions for appeal. 
‘‘(3) CONSTRUCTION.—For purposes of bring-
ing any civil action under paragraph (1), nothing in 
this chapter shall prevent an attorney general of a
State from exercising the powers conferred on the 
attorney general by the laws of such State to con-
duct investigations or to administer oaths or affir-
mations or to compel the attendance of witnesses or 
the production of documentary and other evidence. 
‘‘(4) VENUE; SERVICE OF PROCESS.—Any civil 
action brought under paragraph (1) in a district 
court of the United States may be brought in the 
district in which the defendant is found, is an inhab-
itant, or transacts business or wherever venue is 
proper under section 1391 of title 28, United States 
Code. Process in such an action may be served in 
any district in which the defendant is an inhabitant 
or in which the defendant may be found. 
‘‘(5) ACTIONS BY OTHER STATE OFFICIALS.—
‘‘(A) Nothing contained in this section 
shall prohibit an authorized State official from 
proceeding in State court on the basis of an al-
leged violation of any civil or criminal statute of 
such State. 
‘‘(B) In addition to actions brought by an 
attorney general of a State under paragraph 
(1), such an action may be brought by officers 
of such State who are authorized by the State
to bring actions in such State on behalf of its 
residents. 
‘‘(d) DEFINITIONS.—
‘‘(1) INTERNET-RELATED
DEFINITIONS.—For 
purposes of this section: 
‘‘(A) The term ‘Internet’ means collectively 
the myriad of computer and telecommunications 
facilities, including equipment and operating 
software, which comprise the interconnected 
world-wide network of networks that employ the 
transmission control protocol/internet protocol, 
or any predecessor or successor protocols to 
such protocol, to communicate information of 
all kinds by wire or radio. 
‘‘(B) The term ‘link’, with respect to the 
Internet, means one or more letters, words, 
numbers, symbols, or graphic items that appear 
on a page of an Internet site for the purpose 
of serving, when activated, as a method for exe-
cuting an electronic command—
‘‘(i) to move from viewing one portion 
of a page on such site to another portion 
of the page;
‘‘(ii) to move from viewing one page 
on such site to another page on such site; 
or 
‘‘(iii) to move from viewing a page on 
one Internet site to a page on another 
Internet site. 
‘‘(C) The term ‘page’, with respect to the 
Internet, means a document or other file 
accessed at an Internet site. 
‘‘(D)(i) The terms ‘site’ and ‘address’, with 
respect to the Internet, mean a specific location 
on the Internet that is determined by Internet 
Protocol numbers. Such term includes the do-
main name, if any. 
‘‘(ii) The term ‘domain name’ means a 
method of representing an Internet address 
without direct reference to the Internet Protocol 
numbers for the address, including methods 
that use designations such as ‘.com’, ‘.edu’, 
‘.gov’, ‘.net’, or ‘.org’. 
‘‘(iii) The term ‘Internet Protocol num-
bers’ includes any successor protocol for deter-
mining a specific location on the Internet. 
‘‘(2) OTHER
DEFINITIONS.—For purposes of 
this section:
‘‘(A) The term ‘practitioner’ means a prac-
titioner referred to in section 503(b)(1) with re-
spect to issuing a written or oral prescription. 
‘‘(B) The term ‘prescription drug’ means a 
drug that is subject to section 503(b)(1). 
‘‘(C) The term ‘qualifying medical relation-
ship’, with respect to a practitioner and a pa-
tient, has the meaning indicated for such term 
in subsection (b). 
‘‘(e) INTERACTIVE COMPUTER SERVICE; ADVER-
TISING.—No provider of an interactive computer service, 
as defined in section 230(f)(2) of the Communications Act 
of 1934 (47 U.S.C. 230(f)(2)), or of advertising services 
shall be liable under this section for dispensing or selling 
prescription drugs in violation of this section on account 
of another person’s selling or dispensing such drugs, pro-
vided that the provider of the interactive computer service 
or of advertising services does not own or exercise cor-
porate control over such person.’’. 
(b) INCLUSION AS PROHIBITED ACT.—Section 301 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331) is amended by inserting after paragraph (k) the fol-
lowing: 
‘‘(l) The dispensing or selling of a prescription drug 
in violation of section 503B.’’.