40 CFR 439.21
§ 439.21 Special definitions.
United States · 40 CFR — Protection of Environment · Status: effective
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- Citation
- 40 CFR 439.21, § 439.21 Special definitions, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/190274
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.