(a) No person shall offer for sale or use any biologic in North Carolina unless it is registered with the Commissioner. The registration shall be made on forms provided by the Commissioner. The forms shall require the applicant 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 or regulation promulgated thereunder.
(b) The application for registration shall also include a protocol of methods of production in detail which is followed in the production of the biologic, a sample of the label to be placed on the biologic, and any other information prescribed by the board as necessary for the implementation of this Article. (1981, c. 552, s. 1.)
Last modified: March 23, 2014