[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: 21CFR607.35]

[Page 63]
 
                        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. 607.35  Notification of registrant; blood product establishment 

registration number and NDC Labeler Code.

    (a) The Director of the Center for Biologics Evaluation and Research 
will provide to the registrant a validated copy of Form FD-2830 (Blood 
Establishment Registration and Product Listing) as evidence of 
registration. This validated copy will be sent to the location shown for 
the registering establishment, and a copy will be sent to the reporting 
official if at another address. A permanent registration number will be 
assigned to each blood product establishment registered in accordance 
with these regulations.
    (b) If a registered blood product establishment has not previously 
participated in the National Drug Code system, or in the National Health 
Related Items Code system, the National Drug Code (NDC) numbering system 
shall be used in assigning the first five numeric characters, otherwise 
known as the Labeler Code, of the 10-character NDC Code. The Labeler 
Code identifies the manufacturer.
    (c) Although establishment registration and blood product listing 
are required as described in Sec. 607.20, validation of registration 
and the assignment of a NDC Labeler Code do not, in themselves, 
establish that the holder of the registration is legally qualified to 
deal in such products.

[40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 66 
FR 59159, Nov. 27, 2001]

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