[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.5]

[Page 21-22]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 601--LICENSING--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 601.5  Revocation of license.

    (a) A biologics license shall be revoked upon application of the 
manufacturer giving notice of intention to discontinue the manufacture 
of all products manufactured under such license or to discontinue the 
manufacture of a particular product for which a license is held and 
waiving an opportunity for a hearing on the matter.
    (b)(1) The Commissioner shall notify the licensed manufacturer of 
the intention to revoke the biologics license, setting forth the grounds 
for, and offering an opportunity for a hearing on the proposed 
revocation if the Commissioner finds any of the following:

[[Page 22]]

    (i) Authorized Food and Drug Administration employees after 
reasonable efforts have been unable to gain access to an establishment 
or a location for the purpose of carrying out the inspection required 
under Sec. 600.21 of this chapter,
    (ii) Manufacturing of products or of a product has been discontinued 
to an extent that a meaningful inspection or evaluation cannot be made,
    (iii) The manufacturer has failed to report a change as required by 
Sec. 601.12 of this chapter,
    (iv) The establishment or any location thereof, or the product for 
which the license has been issued, fails to conform to the applicable 
standards established in the license and in this chapter designed to 
ensure the continued safety, purity, and potency of the manufactured 
product,
    (v) The establishment or the manufacturing methods have been so 
changed as to require a new showing that the establishment or product 
meets the requirements established in this chapter in order to protect 
the public health, or
    (vi) The licensed product is not safe and effective for all of its 
intended uses or is misbranded with respect to any such use.
    (2) Except as provided in Sec. 601.6 of this chapter, or in cases 
involving willfulness, the notification required in this paragraph shall 
provide a reasonable period for the licensed manufacturer to demonstrate 
or achieve compliance with the requirements of this chapter, before 
proceedings will be instituted for the revocation of the license. If 
compliance is not demonstrated or achieved and the licensed manufacturer 
does not waive the opportunity for a hearing, the Commissioner shall 
issue a notice of opportunity for hearing on the matter under 
Sec. 12.21(b) of this chapter.

[64 FR 56451, Oct. 20, 1999]