StacksVerified U.S. regulatory reference

40 CFR §439.41

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
For the purpose of this subpart:
  1. (a)Mixing, compounding, and formulating operations means processes that put pharmaceutical products in dosage forms.
  2. (b)Product means any pharmaceutical product manufactured by blending, mixing, compounding, and formulating pharmaceutical ingredients. The term includes pharmaceutical preparations for both human and veterinary use such as ampules, tablets, capsules, vials, ointments, medicinal powders, solutions, and suspensions.