§360aaa–2. Establishment of list of articles and publications disseminated and list of providers that received articles and reference publications

(a) In general

A manufacturer may disseminate information under section 360aaa of this title on a new use only if the manufacturer prepares and submits to the Secretary biannually-

(1) a list containing the titles of the articles and reference publications relating to the new use of drugs or devices that were disseminated by the manufacturer to a person described in section 360aaa(a) of this title for the 6-month period preceding the date on which the manufacturer submits the list to the Secretary; and

(2) a list that identifies the categories of providers (as described in section 360aaa(a) of this title) that received the articles and reference publications for the 6-month period described in paragraph (1).

(b) Records

A manufacturer that disseminates information under section 360aaa of this title shall keep records that may be used by the manufacturer when, pursuant to section 360aaa–4 of this title, such manufacturer is required to take corrective action and shall be made available to the Secretary, upon request, for purposes of ensuring or taking corrective action pursuant to such section. Such records, at the Secretary's discretion, may identify the recipient of information provided pursuant to section 360aaa of this title or the categories of such recipients.

(June 25, 1938, ch. 675, §553, as added Pub. L. 105–115, title IV, §401(a), Nov. 21, 1997, 111 Stat. 2359 .)

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.