§ 5.204 - Notification of release for distribution of biological products.

Related Notices

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(a) The following officials are authorized to issue written notices of release for distribution of licensed biological products under subchapter F (parts 600 through 680.31) of this chapter:

(1) The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).

(2) The Director and Deputy Directors, Office of Compliance and Biologics Quality (OCBQ), CBER.

(3) The Director and Deputy Director, Division of Manufacturing and Product Quality, OCBQ, CBER.

(b) These officials may not further redelegate this authority.

                    
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