[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR99.1]
[Page 446]
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
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.
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