- (a) An application for an initial license to produce biologics shall be accompanied by an application fee of one hundred dollars ($100.00) and a license fee of one hundred dollars ($100.00).
(b) Applications for a license to produce biologics shall contain all of the following:
- (1) the name and address of the person who owns the establishment proposed to produce biologics;
- (2) the name and address of the person in charge of biologics production;
- (3) the type(s) of biologics to be produced;
- (4) a full description of the building, including its location, facilities, equipment, and apparatus to be used in biologics production; and
- (5) such other information as may be required by the Commissioner.
History Note: Authority G.S. 106‑710; 106‑712; 106‑713;
Eff. April 1, 1984;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 26, 2017.