Regulations last checked for updates: May 01, 2025

Title 40 - Protection of Environment last revised: Nov 01, 2025
§ 439.41 - Special definitions.

For the purpose of this subpart:

(a) Mixing, compounding, and formulating operations means processes that put pharmaceutical products in dosage forms.

(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.

[68 FR 12274, Mar. 13, 2003]
source: 48 FR 49821, Oct. 27, 1983, unless otherwise noted.
cite as: 40 CFR 439.41