
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360aaa-5]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
             Part D--Dissemination of Treatment Information
 
Sec. 360aaa-5. Definitions

    For purposes of this part:
        (1) The term ``health care practitioner'' means a physician, or 
    other individual who is a provider of health care, who is licensed 
    under the law of a State to prescribe drugs or devices.
        (2) The terms ``health insurance issuer'' and ``group health 
    plan'' have the meaning given such terms under section 300gg-91 of 
    title 42.
        (3) The term ``manufacturer'' means a person who manufactures a 
    drug or device, or who is licensed by such person to distribute or 
    market the drug or device.
        (4) The term ``new use''--
            (A) with respect to a drug, means a use that is not included 
        in the labeling of the approved drug; and
            (B) with respect to a device, means a use that is not 
        included in the labeling for the approved or cleared device.

        (5) The term ``scientific or medical journal'' means a 
    scientific or medical publication--
            (A) that is published by an organization--
                (i) that has an editorial board;
                (ii) that utilizes experts, who have demonstrated 
            expertise in the subject of an article under review by the 
            organization and who are independent of the organization, to 
            review and objectively select, reject, or provide comments 
            about proposed articles; and
                (iii) that has a publicly stated policy, to which the 
            organization adheres, of full disclosure of any conflict of 
            interest or biases for all authors or contributors involved 
            with the journal or organization;

            (B) whose articles are peer-reviewed and published in 
        accordance with the regular peer-review procedures of the 
        organization;
            (C) that is generally recognized to be of national scope and 
        reputation;
            (D) that is indexed in the Index Medicus of the National 
        Library of Medicine of the National Institutes of Health; and
            (E) that is not in the form of a special supplement that has 
        been funded in whole or in part by one or more manufacturers.

(June 25, 1938, ch. 675, Sec. 556, as added Pub. L. 105-115, title IV, 
Sec. 401(a), Nov. 21, 1997, 111 Stat. 2362.)

                         Termination of Section

        For termination of section by section 401(e) of Pub. L. 105-115, 
    see Effective and Termination Dates note set out under section 
    360aaa of this title.

                  Section Referred to in Other Sections

    This section is referred to in sections 360aaa-1, 360aaa-6 of this 
title.
