[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: 21CFR316.23]

[Page 174]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 316--ORPHAN DRUGS--Table of Contents
 
                Subpart C--Designation of an Orphan Drug
 
Sec. 316.23  Timing of requests for orphan-drug designation; designation of already approved drugs.

    (a) A sponsor may request orphan-drug designation at any time in the 
drug development process prior to the submission of a marketing 
application for the drug product for the orphan indication.
    (b) A sponsor may request orphan-drug designation of an already 
approved drug product for an unapproved use without regard to whether 
the prior marketing approval was for an orphan-drug indication.

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