[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.9]

[Page 24]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 601_LICENSING--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 601.9  Licenses; reissuance.

    (a) Compliance with requirements. A biologics license, previously 
suspended or revoked, may be reissued or reinstated upon a showing of 
compliance with requirements and upon such inspection and examination as 
may be considered necessary by the Director, Center for Biologics 
Evaluation and Research or the Director, Center for Drug Evaluation and 
Research.
    (b) Exclusion of noncomplying location. A biologics license, 
excluding a location or locations that fail to comply with the 
requirements in this chapter, may be issued without further application 
and concurrently with the suspension or revocation of the license for 
noncompliance at the excluded location or locations.
    (c) Exclusion of noncomplying product(s). In the case of multiple 
products included under a single biologics license application, a 
biologics license may be issued, excluding the noncompliant product(s), 
without further application and concurrently with the suspension or 
revocation of the biologics license for a noncompliant product(s).

[64 FR 56451, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005]

Subpart B [Reserved]