View all text of Subpart A [§ 439.10 - § 439.17]
§ 439.11 - Special definitions.
For 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.