§ 5.75 - Designation of official master and working standards for antibiotic drugs.  


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  • The following officials are authorized to designate official Food and Drug Administration master and working standards for antibiotic drugs under § 430.5 of this chapter:

    (a) The Director, Deputy Center Director for Review Management, and Deputy Center Director for Pharmaceutical Science, Center for Drug Evaluation and Research (CDER).

    (b) The Director and Deputy Director, Office of Testing and Research, Officof Testing and Research, Office of Pharmaceutical Science, CDER.

    (c) The Director and Deputy Director, Division of Research and Testing, Office of Testing and Research, Office of Pharmaceutical Science, CDER.