40 CFR § 439.31 - Special definitions.

---
identifier: "/us/cfr/t40/s439.31"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "40 CFR § 439.31 - Special definitions."
title_number: 40
title_name: "Protection of Environment"
section_number: "439.31"
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"
---


# 439.31 Special definitions.

For the purpose of this subpart:

(a) *Chemical synthesis* means using one or a series of chemical reactions in the manufacturing process of a specified product.

(b) *Product* means any pharmaceutical product manufactured by chemical synthesis.

[68 FR 12273, Mar. 13, 2003]