[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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 26, 2003

  Mr. Stupak 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 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.
                                 <all>