The provisions of this Article and/or regulations promulgated hereunder shall not
(1) Any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative,
allergenic product, or other product propagated or manufactured and prepared at an
establishment holding an unsuspended and unrevoked license issued pursuant to section
351 of the Public Health Service Act (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 product shipped prior to licensing
for development or investigational purposes in compliance with the requirements of
the Federal Food, Drug and Cosmetic Act (21 U.S.C. section 301 et seq.) or the Animal Virus, Serum, and Toxin Law of March 4, 1913 (37 Stat. 832; 21 U.S.C. section 151 et seq.), and rules and regulations promulgated thereunder; and
(3) Any etiological agent shipped in accordance with regulations promulgated under
section 361 of the Public Health Service Act (42 U.S.C. section 264).
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature or via Westlaw before relying on it for your legal needs.
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