REGISTRATION

(a) Registration of a biologic shall be approved when the applicant provides such information concerning protocols, source of biologic agents, purity and safety as may be required by these Rules. (b) Upon approval, a biologic shall be registered upon receipt of a fifty dollar ($50.00) fee. (c) The registration of a biologic shall specify the conditions of use and period for which the registration is granted. (d) No change in composition, protocol of production or labeling of a biologic registered by the Commissioner shall be made without prior approval of the Commissioner. History Note: Authority G.S. 106-709; 106-710; 106-712; 106-713; 106-715; Eff. April 1, 1984; Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 26, 2017.