40 CFR § 439.11 - Special definitions.

§ 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.

[68 FR 12271, Mar. 13, 2003]