[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR99.405]



[Page 454]

 

                        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.