North Carolina Administrative Code
Title 02 - AGRICULTURE AND CONSUMER SERVICES
Chapter 52 - VETERINARY
Subchapter G - BIOLOGICS
Section .0400 - REGISTRATION OF BIOLOGICS
Section 52G .0402 - APPLICATIONS FOR REGISTRATION

Universal Citation: 02 NC Admin Code 52G .0402

Current through Register Vol. 39, No. 6, September 16, 2024

(a) Each application for registration of a biologic shall include a detailed protocol of methods of production which shall specify, as a minimum, the source and type of biologic material used to produce the product and methods used to determine purity and safety of the product during manufacture and distribution.

(b) Each application for registration of a biologic shall include a sample of the label to be used, which shall specify, as a minimum:

(1) the name of the product;

(2) the name of the person producing the biologic as it appears on the license;

(3) the date the product was manufactured;

(4) the expiration date;

(5) the lot number; and

(6) conditions of use.

(c) Each application for registration of a biologic shall include such other information as required by the Commissioner to determine if a product may be hazardous to human or animal health.

Authority G.S. 106-709; 106-712;
Eff. April 1, 1984;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 26, 2017.

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