[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR99.405]

[Page 459]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 99--DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES--Table of Contents
 
      Subpart E--Corrective Actions and Cessation of Dissemination
 
Sec. 99.405  Applicability of labeling, adulteration, and misbranding authority.

    The dissemination of information relating to a new use for a drug or 
device may constitute labeling, evidence of a new intended use, 
adulteration, or misbranding of the drug or device if such dissemination 
fails to comply with section 551 of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360aaa) and the requirements of this part. A 
manufacturer's failure to exercise due diligence in submitting the 
clinical studies that are necessary for the approval of a new use that 
is the subject of information disseminated under this part or in 
beginning or completing such clinical studies shall be deemed a failure 
to comply with section 551 of the act and the requirements of this part.