I
106TH CONGRESS
1ST SESSION
H. R. 2763
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
AUGUST 5, 1999
Mr. KLINK (for himself, Mr. DINGELL, Mr. STUPAK, Mr. WAXMAN, Mr.
GREEN of Texas, Mr. BRADY of Pennsylvania, Mr. KANJORSKI, and Mr.
DOYLE) introduced the following bill; which was referred to the Com-
mittee on 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:
‘‘(B) Each State in which the person is au-
thorized by law to dispense prescription drugs.
‘‘(C) The name of each individual who
serves as a pharmacist for purposes of the site,
and each State in which the individual is au-
thorized by law to dispense prescription drugs.
‘‘(D) If the person provides for medical
consultations through the site for purposes of
providing prescriptions, the name of each indi-
vidual who provides such consultations; each
State in which the individual is licensed or oth-
erwise authorized by law to provide such con-
sultations; and the type or types of health pro-
fessions for which the individual holds such li-
censes or other authorizations.
‘‘(2) Each other page of the site (if any) shall
include either a link to the page referred to in para-
graph (1) or the information described in such para-
graph.
‘‘(3) A link to which paragraph (2) applies shall
be clearly visible on the page involved, shall not be
of a size smaller than other links on the page (if
any), and shall include in the caption for the link ei-
ther the word ‘licensing’ or the word ‘licenses’.
‘‘(c) PRIMARY
ENFORCEMENT
AUTHORITY
FOR
STATES.—
‘‘(1) IN GENERAL.—With respect to the pur-
chase of a prescription drug, if a State has in effect
requirements for Internet sites that are no less
stringent than the requirements established in sub-
section (b) for such sites, and has adequate proce-
dures for the enforcement of the requirements, the
State has primary enforcement responsibility for any
violation involving such a purchase made from with-
in the State.
‘‘(2) DETERMINATION.—The Secretary shall by
regulation establish a procedure through which a
State can, upon the request of the State, obtain
from the Secretary a determination of whether
under paragraph (1) the State has primary enforce-
ment responsibility. Not later than 180 days after
the date of the enactment of the Internet Pharmacy
Consumer Protection Act, the Secretary shall issue
a proposed rule for purposes of the preceding sen-
tence.
‘‘(d) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘Internet’ means collectively the
myriad of computer and telecommunications facili-
ties, including equipment and operating software,
which comprise the interconnected world-wide net-
work of networks that employ the Transmission
Control Protocol/Internet Protocol, or any prede-
cessor or successor protocols to such protocol, to
communicate information of all kinds by wire or
radio.
‘‘(2) The term ‘link’, with respect to the Inter-
net, 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 ac-
tivated, as a method for executing an electronic
command—
‘‘(A) to move from viewing one portion of
a page on such site to another portion of the
page;
‘‘(B) to move from viewing one page on
such site to another page on such site; or
‘‘(C) to move from viewing a page on one
Internet site to a page on another Internet site.
‘‘(3) The term ‘page’, with respect to the Inter-
net, means a document or other file accessed at an
Internet site.
‘‘(4) The term ‘prescription drug’ means a drug
subject to section 503(b).
‘‘(5)(A) The terms ‘site’ and ‘address’, with re-
spect to the Internet, mean a specific location on the
Internet that is determined by Internet protocol
numbers. Such term includes the domain name, if
any.
‘‘(B) 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 the designations
‘.com’, ‘.edu’, ‘.gov’, and ‘.org’.
‘‘(C) The term ‘Internet Protocol numbers’ in-
cludes any successor protocol for determining a spe-
cific location on the Internet.’’.
(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 introduction or delivery for introduction into
interstate commerce of a prescription drug in violation of
section 503B.’’.
SEC. 3. EFFECTIVE DATE.
The amendments made by section 2 take effect upon
the expiration of the 60-day period beginning on the date
of the enactment of this Act, without regard to whether
a final rule to implement such amendments has been pro-
mulgated by the Secretary of Health and Human Services
under section 701(a) of the Federal Food, Drug, and Cos-
metic Act. The preceding sentence may not be construed
as affecting the authority of such Secretary to promulgate
such a final rule.
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