§ 106-712. Registration of biologics. - North Carolina Statutes

§ 106‑712. Registration of biologics.

(a)        No person shall offer for sale or use any biologic in NorthCarolina unless it is registered with the Commissioner. The registration shallbe made on forms provided by the Commissioner. The forms shall require theapplicant to provide information showing that the biologic:

(1)        Is produced under procedures approved by the Commissioner;

(2)        Is safe and noninjurious to animals when used as directed;

(3)        Is labeled for proper handling, use and contents;

(4)        Is produced in an establishment licensed under this Article;and

(5)        Is not in violation of this Article or any rule orregulation promulgated thereunder.

(b)        The application for registration shall also include aprotocol of methods of production in detail which is followed in the productionof the biologic, a sample of the label to be placed on the biologic, and anyother information prescribed by the board as necessary for the implementationof this Article. (1981, c. 552, s.1.)