[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: 21CFR99.1]



[Page 443-444]

 

                        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 444]]



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.