[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2652 Introduced in House (IH)]
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.
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IN THE HOUSE OF REPRESENTATIVES
June 26, 2003
Mr. Stupak introduced the following bill; which was referred to the
Committee on Energy and Commerce
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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 Representatives 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 amended by inserting after section 503A
the following section:
``SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.
``(a) In General.--A person may not introduce a prescription drug
into interstate commerce or deliver the prescription drug for
introduction into such commerce pursuant to a sale of the drug by such
person if--
``(1) 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
``(2) 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 requirements specified in subsection (b)
(other than a site or pages on a site that are not intended to
be accessed by purchasers or prospective purchasers).
``(b) Requirements.--With respect to an Internet site, the
requirements referred to in paragraph (2) of subsection (a) for a
person to whom such subsection applies are as follows:
``(1) The site shall include a page that provides the
following information:
``(A) The name of such person; the address of the
principal place of business of the person with respect
to sales of prescription drugs through the Internet;
and the telephone number for such place of business.
``(B) Each State in which the person is authorized
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 authorized 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 individual
who provides such consultations; each State in which
the individual is licensed or otherwise authorized by
law to provide such consultations; and the type or
types of health professions for which the individual
holds such licenses or other authorizations.
``(2) Each other page of the site (if any) shall include
either a link to the page referred to in paragraph (1) or the
information described in such paragraph.
``(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 either the word `licensing'
or the word `licenses'.
``(c) Primary Enforcement Authority for States.--
``(1) In general.--With respect to the purchase of a
prescription drug, if a State has in effect requirements for
Internet sites that are no less stringent than the requirements
established in subsection (b) for such sites, and has adequate
procedures for the enforcement of the requirements, the State
has primary enforcement responsibility for any violation
involving such a purchase made from within 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
enforcement 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 sentence.
``(d) Definitions.--For purposes of this section:
``(1) 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.
``(2) 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 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 Internet, 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 respect 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' includes any
successor protocol for determining a specific 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 following:
``(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 promulgated by the Secretary of Health and Human Services under
section 701(a) of the Federal Food, Drug, and Cosmetic 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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