21 C.F.R. § 607.35 Notification of registrant; blood product establishment registration number and NDC Labeler Code.
Title 21 - Food and Drugs
(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 §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]
Title 21: Food and Drugs
PART 607—ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
Subpart B—Procedures for Domestic Blood Product Establishments
§ 607.35 Notification of registrant; blood product establishment registration number and NDC Labeler Code.
