[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.36]

[Page 65-66]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
          Subpart B--Investigational New Drug Application (IND)
 
Sec. 312.36  Emergency use of an investigational new drug.

    Need for an investigational drug may arise in an emergency situation 
that does not allow time for submission of an IND in accordance with 
Sec. 312.23 or

[[Page 66]]

Sec. 312.34. In such a case, FDA may authorize shipment of the drug for 
a specified use in advance of submission of an IND. A request for such 
authorization may be transmitted to FDA by telephone or other rapid 
communication means. For investigational biological drugs, the request 
should be directed to the Division of Biological Investigational New 
Drugs (HFB-230), Center for Biologics Evaluation and Research, 8800 
Rockville Pike, Bethesda, MD 20892, 301-443-4864. For all other 
investigational drugs, the request for authorization should be directed 
to the Document Management and Reporting Branch (HFD-53), Center for 
Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857, 
301-443-4320. After normal working hours, eastern standard time, the 
request should be directed to the FDA Division of Emergency and 
Epidemiological Operations, 202-857-8400. Except in extraordinary 
circumstances, such authorization will be conditioned on the sponsor 
making an appropriate IND submission as soon as practicable after 
receiving the authorization.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 55 
FR 11579, Mar. 29, 1990; 67 FR 9585, Mar. 4, 2002]