§ 106-710. Biologics production license.

197 words·~1 min read·/nc/chapter-106/106-710

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)No person shall engage in the production of biologics except in:

(1)An establishment licensed by the Department;

(2)An establishment licensed by the United States Department of Agriculture; or

(3)An establishment producing biologics only for use by the owner or operator of the establishment for animals owned by him, if the biologics are registered with the Commissioner.

(b)Any establishment applying for a license to produce biologics shall be inspected by the Commissioner. Approval shall be based on compliance with the rules and regulations adopted by the board.

(c)Application for a license to produce biologics shall be made on forms provided by the Commissioner and shall be accompanied by a reasonable fee as established by the board.

(d)Upon approval, a license shall be granted upon payment of the annual license fee of one hundred dollars ($100.00) for each establishment licensed, and an additional fee of fifty dollars ($50.00) for each product produced at any time during the year. This license shall be renewed annually. The annual renewal fee shall be paid on or before the first day of July of each year. (1981, c. 552, s. 1.)