[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4990 Reported in House (RH)]

                                                 Union Calendar No. 327


                                    


107th CONGRESS
  2d Session
                                H. R. 4990

                          [Report No. 107-546]

    To amend the Federal Food, Drug, and Cosmetic Act to establish 
    requirements with respect to the sale of, or the offer to sell, 
    prescription drugs through the Internet, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 21, 2002

  Mr. Tauzin introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

                             June 26, 2002

Committed to the Committee of the Whole House on the State of the Union 
                       and ordered to be printed

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to establish 
    requirements with respect to the sale of, or the offer to sell, 
    prescription drugs through the Internet, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

                    Subtitle B--Internet Pharmacies

SEC. 911. FINDINGS.

  The Congress finds as follows:
            (1) Legitimate Internet sellers of prescription drugs can 
        offer substantial benefits to consumers. These potential 
        benefits include convenience, privacy, valuable information, 
        competitive prices, and personalized services.
            (2) Unlawful Internet sellers of prescription drugs may 
        dispense inappropriate, contaminated, counterfeit, or subpotent 
        prescription drugs that could put at risk the health and safety 
        of consumers.
            (3) Unlawful Internet sellers have exposed consumers to 
        significant health risks by knowingly filling invalid 
        prescriptions, such as prescriptions based solely on an online 
        questionnaire, or by dispensing prescription drugs without any 
        prescription.
            (4) Consumers may have difficulty distinguishing legitimate 
        from unlawful Internet sellers, as well as foreign from 
        domestic Internet sellers, of prescription drugs.

SEC. 912. AMENDMENT TO FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A 
the following:

``SEC. 503B. INTERNET PRESCRIPTION DRUG SALES.

    ``(a) Definitions.--For purposes of this section:
            ``(1) Consumer.--The term `consumer' means a person (other 
        than an entity licensed or otherwise authorized under Federal 
        or State law as a pharmacy or to dispense or distribute 
        prescription drugs) that purchases or seeks to purchase 
        prescription drugs through the Internet.
            ``(2) Home page.--The term `home page' means the entry 
        point or main web page for an Internet site.
            ``(3) Internet.--The term `Internet' means collectively the 
        myriad of computer and telecommunications facilities, including 
        equipment and operating software, which comprise the 
        interconnected worldwide 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, 
        including electronic mail.
            ``(4) Interstate internet seller.--
                    ``(A) In general.--The term `interstate Internet 
                seller' means a person whether in the United States or 
                abroad, that engages in, offers to engage in, or causes 
                the delivery or sale of a prescription drug through the 
                Internet and has such drug delivered directly to the 
                consumer via the Postal Service, or any private or 
                commercial interstate carrier to a consumer in the 
                United States who is residing in a State other than the 
                State in which the seller's place of business is 
                located. This definition excludes a person who only 
                delivers a prescription drug to a consumer, such as an 
                interstate carrier service.
                    ``(B) Exemption.--With respect to the consumer 
                involved, the term `interstate Internet seller' does 
                not include a person described in subparagraph (A) 
                whose place of business is located within 75 miles of 
                the consumer.
            ``(5) Link.--The term `link' means either a textual or 
        graphical marker on a web page that, when clicked on, takes the 
        consumer to another part of the Internet, such as to another 
        web page or a different area on the same web page, or from an 
        electronic message to a web page.
            ``(6) Pharmacy.--The term `pharmacy' means any place 
        licensed or otherwise authorized as a pharmacy under State law.
            ``(7) Prescriber.--The term `prescriber' means an 
        individual, licensed or otherwise authorized under applicable 
        Federal and State law to issue prescriptions for prescription 
        drugs.
            ``(8) Prescription drug.--The term `prescription drug' 
        means a drug under section 503(b)(1).
            ``(9) Valid prescription.--The term `valid prescription' 
        means a prescription that meets the requirements of section 
        503(b)(1) and other applicable Federal and State law.
            ``(10) Web site; site.--The terms `web site' and `site' 
        mean a specific location on the Internet that is determined by 
        Internet protocol numbers or by a domain name.
    ``(b) Requirements for Interstate Internet Sellers.--
            ``(1) In general.--Each interstate Internet seller shall 
        comply with the requirements of this subsection with respect to 
        the sale of, or the offer to sell, prescription drugs through 
        the Internet and shall at all times display on its web site 
information in accordance with paragraph (2).
            ``(2) Web site disclosure information.--An interstate 
        Internet seller shall post in a visible and clear manner (as 
        determined by regulation) on the home page of its web site, or 
        on a page directly linked to such home page--
                    ``(A) the street address of the interstate Internet 
                seller's place of business, and the telephone number of 
                such place of business;
                    ``(B) each State in which the interstate Internet 
                seller is licensed or otherwise authorized as a 
                pharmacy, or if the interstate Internet seller is not 
                licensed or otherwise authorized by a State as a 
                pharmacy, each State in which the interstate Internet 
                seller is licensed or otherwise authorized to dispense 
                prescription drugs, and the type of State license or 
                authorization;
                    ``(C) in the case of an interstate Internet seller 
                that makes referrals to or solicits on behalf of a 
                prescriber, the name of each prescriber, the street 
                address of each such prescriber's place of business, 
                the telephone number of such place of business, each 
                State in which each such prescriber is licensed or 
                otherwise authorized to prescribe prescription drugs, 
                and the type of such license or authorization; and
                    ``(D) a statement that the interstate Internet 
                seller will dispense prescription drugs only upon a 
                valid prescription.
            ``(3) Date of posting.--Information required to be posted 
        under paragraph (2) shall be posted by an interstate Internet 
        seller--
                    ``(A) not later than 90 days after the effective 
                date of this section if the web site of such seller is 
                in operation as of such date; or
                    ``(B) on the date of the first day of operation of 
                such seller's web site if such site goes into operation 
                after such date.
            ``(4) Qualifying statements.--An interstate Internet seller 
        shall not indicate in any manner that posting disclosure 
        information on its web site signifies that the Federal 
        Government has made any determination on the legitimacy of the 
        interstate Internet seller or its business.
            ``(5) Disclosure to state licensing boards.--An interstate 
        Internet seller licensed or otherwise authorized to dispense 
        prescription drugs in accordance with applicable State law 
        shall notify each State entity that granted such licensure or 
        authorization that it is an interstate Internet seller, the 
        name of its business, the Internet address of its business, the 
        street address of its place of business, and the telephone 
        number of such place of business.
            ``(6) Regulations.--The Secretary is authorized to 
        promulgate such regulations as are necessary to carry out the 
        provisions of this subsection. In issuing such regulations, the 
        Secretary--
                    ``(A) shall take into consideration disclosure 
                formats used by existing interstate Internet seller 
                certification programs; and
                    ``(B) shall in defining the term `place of 
                business' include provisions providing that such place 
                is a single location at which employees of the business 
                perform job functions, and not a post office box or 
                similar locale.''.
    (b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(bb) The failure to post information required under section 
503B(b)(2) or for knowingly making a materially false statement when 
posting such information as required under such section or violating 
section 503B(b)(4).''.

SEC. 913. PUBLIC EDUCATION.

    The Secretary of Health and Human Services shall engage in 
activities to educate the public about the dangers of purchasing 
prescription drugs from unlawful Internet sources. The Secretary should 
educate the public about effective public and private sector consumer 
protection efforts, as appropriate, with input from the public and 
private sectors, as appropriate.

SEC. 914. STUDY REGARDING COORDINATION OF REGULATORY ACTIVITIES.

    Not later than 180 days after the date of enactment of this Act, 
the Secretary of Health and Human Services, after consultation with the 
Attorney General, shall submit to Congress a report providing 
recommendations for coordinating the activities of Federal agencies 
regarding interstate Internet sellers that operate from foreign 
countries and for coordinating the activities of the Federal Government 
with the activities of governments of foreign countries regarding such 
interstate Internet sellers.

SEC. 915. EFFECTIVE DATE.

    The amendments made by this subtitle shall take effect 1 year after 
the date of enactment of this Act, except that the authority of the 
Secretary of Health and Human Services to commence the process of 
rulemaking is effective on the date of enactment of this Act.




                                                 Union Calendar No. 327

107th CONGRESS

  2d Session

                               H. R. 4990

                          [Report No. 107-546]

_______________________________________________________________________

                                 A BILL

    To amend the Federal Food, Drug, and Cosmetic Act to establish 
    requirements with respect to the sale of, or the offer to sell, 
    prescription drugs through the Internet, and for other purposes.

_______________________________________________________________________

                             June 26, 2002

Committed to the Committee of the Whole House on the State of the Union 
                       and ordered to be printed