[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR99.1]

[Page 471-472]
 
                        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.




                      Subpart A_General Information

Sec.
99.1 Scope.
99.3 Definitions.

                Subpart B_Information to be Disseminated

99.101 Information that may be disseminated.
99.103 Mandatory statements and information.
99.105 Recipients of information.

    Subpart C_Manufacturer's Submissions, Requests, and Applications

99.201 Manufacturer's submission to the agency.
99.203 Request to extend the time for completing planned studies.
99.205 Application for exemption from the requirement to file a 
          supplemental application.

     Subpart D_FDA Action on Submissions, Requests, and Applications

99.301 Agency action on a submission.
99.303 Extension of time for completing planned studies.
99.305 Exemption from the requirement to file a supplemental 
          application.

       Subpart E_Corrective Actions and Cessation of Dissemination

99.401 Corrective actions and cessation of dissemination of information.
99.403 Termination of approvals of applications for exemption.

[[Page 472]]

99.405 Applicability of labeling, adulteration, and misbranding 
          authority.

                   Subpart F_Recordkeeping and Reports

99.501 Recordkeeping and reports.

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 
360aa-360aaa-6, 371, and 374; 42 U.S.C. 262.

    Source: 63 FR 64581, Nov. 20, 1998, unless otherwise noted.



    (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.