[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR99.1]

[Page 449]
 
                        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 A--General Information
 
Sec. 99.1  Scope.


    (a) This part applies to the dissemination of information on human 
drugs, including biologics, and devices where the information to be 
disseminated:
    (1) Concerns the safety, effectiveness, or benefit of a use that is 
not included in the approved labeling for a drug or device approved by 
the Food and Drug Administration for marketing or in the statement of 
intended use for a device cleared by the Food and Drug Administration 
for marketing; and
    (2) Will be disseminated to a health care practitioner, pharmacy 
benefit manager, health insurance issuer, group health plan, or Federal 
or State Government agency.
    (b) This part does not apply to a manufacturer's dissemination of 
information that responds to a health care practitioner's unsolicited 
request.