§ 106-65.49. Article not applicable in certain cases. - North Carolina Statutes

§ 106‑65.49. Article not applicable in certain cases.

The provisions of this Article and/or regulations promulgated hereundershall not apply to:

(1)        Any virus, serum, toxin, antitoxin, vaccine, blood, bloodcomponent or derivative, allergenic product, or other product propagated ormanufactured and prepared at an establishment holding an unsuspended andunrevoked license issued pursuant to section 351 of the Public Health ServiceAct (42 U.S.C. section 262) and regulations promulgated thereunder;

(2)        Any finished virus, serum, toxin, antitoxin, vaccine, blood,blood component or derivative, allergenic product or other biological productshipped prior to licensing for development or investigational purposes incompliance with the requirements of the Federal Food, Drug and Cosmetic Act (21U.S.C. section 301 et seq.) or the Animal Virus, Serum, and Toxin Law of March4, 1913 (37 Stat. 832; 21 U.S.C. section 151 et seq.), and rules andregulations promulgated thereunder; and

(3)        Any etiological agent shipped in accordance with regulationspromulgated under section 361 of the Public Health Service Act (42 U.S.C.section 264). (1973, c. 1091.)