SECTION .0200 ‑ LICENSES

02 NCAC 52G .0201         BIOLOGICS PRODUCTION LICENSE APPLICATION AND FEES

(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.