[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: 21CFR607.21]

[Page 56]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
     Subpart B--Procedures for Domestic Blood Product Establishments
 
Sec. 607.21  Times for establishment registration and blood product listing.

    The owner or operator of an establishment entering into an operation 
defined in Sec. 607.3(d) shall register such establishment within 5 days 
after the beginning of such operation and submit a list of every blood 
product in commercial distribution at the time. If the owner or operator 
of the establishment has not previously entered into such operation 
(defined in Sec. 607.3(d) of this chapter) for which a license is 
required, registration shall follow within 5 days after the submission 
of a biologics license application in order to manufacture blood 
products. Owners or operators of all establishments so engaged shall 
register annually between November 15 and December 31 and shall update 
their blood product listing information every June and December.

[40 FR 52788, Nov. 12, 1975, as amended at 64 FR 56453, Oct. 20, 1999]