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e-CFR data is current as of December 3, 2020

Title 40Chapter ISubchapter NPart 439Subpart A → §439.11


Title 40: Protection of Environment
PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY
Subpart A—Fermentation Products


§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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