§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, §556, as added Pub. L. 105–115, title IV, §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.