[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: 21CFR607.25]

[Page 62]
 
                        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. 607.25  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 name and street 
address of the establishment, including post office 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 the 
parent establishment. An establishment not owned, operated, or 
controlled by another firm or establishment is its own parent 
establishment.

[40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11013, Mar. 26, 1990; 66 FR 59158, Nov. 27, 2001]