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]

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United States Code