[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: 21CFR607.7]

[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 A_General Provisions
 
Sec. 607.7  Establishment registration and product listing of blood banks and 

other firms manufacturing human blood and blood products.

    (a) All owners or operators of establishments that engage in the 
manufacturing of blood products are required to register, pursuant to 
section 510 of the Federal Food, Drug, and Cosmetic Act. Registration 
and listing of blood products shall comply with this part. Registration 
does not permit any blood bank or similar establishment to ship blood 
products in interstate commerce.
    (b) Forms for registration of an establishment are obtainable on 
request from the Center for Biologics Evaluation and Research (HFM-375) 
(see mailing addresses in Sec. 600.2 of this chapter), or at any of the 
Food and Drug Administration district offices.
    (c) The completed form should be mailed to the Center for Biologics 
Evaluation and Research (HFM-375) (see mailing addresses in Sec. 600.2 
of this chapter).

[40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11014, Mar. 26, 1990; 66 FR 59158, Nov. 27, 2001; 70 FR 14984, Mar. 
24, 2005]