[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: 21CFR601.6]

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                        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. 601.6  Suspension of license.

    (a) Whenever the Commissioner has reasonable grounds to believe that 
any of the grounds for revocation of a license exist and that by reason 
thereof there is a danger to health, the Commissioner may notify the 
licensed manufacturer that the biologics license is suspended and 
require that the licensed manufacturer do the following:
    (1) Notify the selling agents and distributors to whom such product 
or products have been delivered of such suspension, and

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    (2) Furnish to the Center for Biologics Evaluation and Research or 
the Center for Drug Evaluation and Research, complete records of such 
deliveries and notice of suspension.
    (b) Upon suspension of a license, the Commissioner shall either:
    (1) Proceed under the provisions of Sec. 601.5(b) of this chapter 
to revoke the license, or
    (2) If the licensed manufacturer agrees, hold revocation in abeyance 
pending resolution of the matters involved.

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