40 CFR § 439.11
Special definitions
June 9, 2020
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.
[68 FR 12271, Mar. 13, 2003]
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