HR 2763 IH

To amend the Federal Food, Drug, and Cosmetic Act with respect to the sale of prescription drugs through the Internet.

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 Committee on Commerce

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.

END