StacksVerified U.S. regulatory reference

40 CFR §439.11

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
For the purpose of this subpart:
  1. (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.
  2. (b)Product means pharmaceutical products derived from fermentation processes.