Section 439.11 - Special definitionsFor the purpose of this subpart:
(a)Fermentation means process operations that utilize a chemical change induced by a living organism or enzyme, specifically, bacteria, or the microorganisms occurring in unicellular plants such as yeast, molds, or fungi to produce a specified product.(b)Product means pharmaceutical products derived from fermentation processes.68 FR 12271, Mar. 13, 2003