Code of Federal Regulations Title 21. Food and Drugs § 21.316.23 Timing of requests for orphan-drug designation;  designation of already approved drugs

(a) A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition.

(b) A sponsor may request orphan-drug designation of an already approved drug for an unapproved use without regard to whether the prior marketing approval was for a rare disease or condition.