SEC. 553. [21 USC §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 551 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 551(a) 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 551(a)) 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 551 shall keep records that may be used by the manufacturer when, pursuant to section 555, 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 551 or the categories of such recipients.