[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: 21CFR316.36]

[Page 177-178]
 
                        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 D--Orphan-drug Exclusive Approval
 
Sec. 316.36  Insufficient quantities of orphan drugs.

    (a) Under section 527 of the act, whenever the Director has reason 
to believe that the holder of exclusive approval cannot assure the 
availability of sufficient quantities of an orphan drug to meet the 
needs of patients with the disease or condition for which the drug was 
designated, the Director will so notify the holder of this possible 
insufficiency and will offer the holder one of the following options, 
which must be exercised by a time that the Director specifies:
    (1) Provide the Director in writing, or orally, or both, at the 
Director's discretion, views and data as to how the holder can assure 
the availability of sufficient quantities of the orphan drug within a 
reasonable time to meet the needs of patients with the disease or 
condition for which the drug was designated; or
    (2) Provide the Director in writing the holder's consent for the 
approval of other marketing applications for the same drug before the 
expiration of the 7-year period of exclusive approval.
    (b) If, within the time that the Director specifies, the holder 
fails to consent to the approval of other marketing applications and if 
the Director finds that the holder has not shown that it can assure the 
availability of sufficient quantities of the orphan drug to meet the 
needs of patients with the disease or condition for which the drug was 
designated, the Director will issue a written order withdrawing the drug 
product's exclusive approval. This

[[Page 178]]

order will embody the Director's findings and conclusions and will 
constitute final agency action. An order withdrawing the sponsor's 
exclusive marketing rights may issue whether or not there are other 
sponsors that can assure the availability of alternative sources of 
supply. Once withdrawn under this section, exclusive approval may not be 
reinstated for that drug.