40 CFR § 439.21 - Special definitions.

---
identifier: "/us/cfr/t40/s439.21"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "40 CFR § 439.21 - Special definitions."
title_number: 40
title_name: "Protection of Environment"
section_number: "439.21"
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"
---


# 439.21 Special definitions.

For the purpose of this subpart:

(a) *Extraction* means process operations that derive pharmaceutically active ingredients from natural sources such as plant roots and leaves, animal glands, and parasitic fungi by chemical and physical extraction.

(b) *Product* means any substance manufactured by an extraction process, including blood fractions, vaccines, serums, animal bile derivatives, endocrine products and medicinal products such as alkaloids that are isolated from botanical drugs and herbs.

[68 FR 12272, Mar. 13, 2003]