[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: 21CFR607.20]

[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. 607.20  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 607, that engage in 
the manufacture of blood products are required to register and to submit 
a list of every blood product in commercial distribution (except that 
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), 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]