[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: 21CFR607.25]

[Page 56-57]
 
                        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. 607.25  Information required for establishment registration and blood product listing.

    (a) Form FD-2830 (Blood Establishment Registration and Product 
Listing) requires furnishing or confirming registration information 
required by the act. This information includes the

[[Page 57]]

name and street address of the establishment, including post office ZIP 
code; all trade names used by the establishment; the kind of ownership 
or operation (that is, individually owned partnership, or corporation); 
and the name of the owner or operator of such establishment. The term 
``name of the owner or operator'' shall include in the case of a 
partnership the name of each partner, and in the case of a corporation 
the name and title of each corporate officer and director and the name 
of the State of incorporation. The information required shall be given 
separately for each establishment, as defined in Sec. 607.3(c).
    (b) Form FD-2830 also requires furnishing blood product listing 
information required by the act as follows:
    (1) A list of blood products, including bulk product substances as 
well as finished dosage forms, by established name as defined in section 
502(e) of the act and by proprietary name, which are being manufactured 
for commercial distribution and which have not been included in any list 
previously submitted on Form FD-2830 (Blood Establishment Registration 
and Product Listing) or Form FD-2250 (National Drug Code Directory 
Input).
    (2) For each blood product so listed which is subject to section 351 
of the Public Health Service Act, the license number of the manufacturer 
issued by the Center for Biologics Evaluation and Research, Food and 
Drug Administration.
    (3) For each blood product listed, the registration number of every 
blood product establishment within the parent company at which it is 
manufactured.

[40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11013, Mar. 26, 1990]