[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: 21CFR607.35]

[Page 58]
 
                        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. 607.35  Notification of registrant; blood product establishment registration number and NDC Labeler Code.

    (a) The Commissioner 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 only to 
the location shown for the registering establishment. 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]