§ 5.73 - Certification of insulin.

The following officials are authorized to certify or reject batches of drugs containing insulin pursuant to section 506(a) of the Federal Food, Drug, and Cosmetic Act:

(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, Office of Drug Evaluation II, Office of Review Management, CDER.

(c) The Director and Deputy Director, Division of Metabolism and Endocrine Drug Products, Office of Drug Evaluation II, Office of Review Management, CDER.

(d) The Director and Deputy Director, Office of Compliance, CDER.

(e) The Director and Deputy Director, Division of Prescription Drug Compliance and Surveillance, Office of Compliance, CDER.

(f) The Team Leader and Assistant, Post-Marketing Surveillance Team, Division of Prescription Drug Compliance and Surveillance, Office of Compliance, CDER.