[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: 21CFR607.20]

[Page 61]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 607_ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF 
 
     Subpart B_Procedures for Domestic Blood Product Establishments
 
Sec. 607.20  Who must register and submit a blood product list.


    (a) Owners or operators of all establishments, not exempt under 
section 510(g) of the act or subpart D of this part, that engage in the 
manufacture of blood products shall register and submit a list of every 
blood product in commercial distribution (except that registration and 
listing information may be submitted by the parent, subsidiary, and/or 
affiliate company for all establishments when operations are conducted 
at more than one establishment and there exists joint ownership and 
control among all the establishments). Blood products manufactured, 
prepared, propagated, compounded, or processed in any State as defined 
in section 201(a)(1) of the act must be listed whether or not the output 
of such blood product establishment or any particular blood product so 
listed enters interstate commerce.
    (b) Preparatory to engaging in the manufacture of blood products, 
owners or operators of establishments who are submitting a biologics 
license application to manufacture blood products are required to 
register before the biologics license application is approved.
    (c) No registration fee is required. Establishment registration and 
blood product listing do not constitute an admission or agreement or 
determination that a blood product is a ``drug'' within the meaning of 
section 201(g) of the act.

[40 FR 52788, Nov. 12, 1975, as amended at 64 FR 56452, Oct. 20, 1999; 
66 FR 59158, Nov. 27, 2001]