40 CFR § 439.41 - Special definitions.

---
identifier: "/us/cfr/t40/s439.41"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "40 CFR § 439.41 - Special definitions."
title_number: 40
title_name: "Protection of Environment"
section_number: "439.41"
section_name: "Special definitions."
chapter_name: "ENVIRONMENTAL PROTECTION AGENCY"
subchapter_number: "N"
subchapter_name: "EFFLUENT GUIDELINES AND STANDARDS"
part_number: "439"
part_name: "PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "33 U.S.C. 1311, 1314, 1316, 1317, 1318, 1342 and 1361."
regulatory_source: "48 FR 49821, Oct. 27, 1983, unless otherwise noted."
cfr_part: "439"
---


# 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]