StacksVerified U.S. regulatory reference

40 CFR §439.31

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
For the purpose of this subpart:
  1. (a)Chemical synthesis means using one or a series of chemical reactions in the manufacturing process of a specified product.
  2. (b)Product means any pharmaceutical product manufactured by chemical synthesis.