SECTION .0400 ‑ REGISTRATION OF BIOLOGICS

 

02 NCAC 52G .0401          BIOLOGICS REQUIRING REGISTRATION

(a)  Each biologic produced in an establishment licensed by the Commissioner shall be separately registered, except as provided in (b) and (c) of this Rule.

(b)  Biologics produced by a licensed veterinarian for prevention or treatment of disease in animals which are under his care and are administered only by him or under his supervision to such animals need not be registered.

(c)  Biologics which are produced pursuant to 9 CFR 102.5 (U.S. Veterinary Biological Product License) need not be registered with the Commissioner.

(d)  The Commissioner may require registration of any biologic when he determines it necessary to prevent the spread or introduction of infection or disease and to assure its safe and effective use.

 

History Note:        Authority G.S. 106‑709; 106‑712;

Eff. April 1, 1984;

Amended Eff. April 1, 1985;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 26, 2017.