
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-2]

 
                        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-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, Sec. 553, as added Pub. L. 105-115, title IV, 
Sec. 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.
