21 CFR § 200.15 - Definition of term “insulin.”

---
identifier: "/us/cfr/t21/s200.15"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 200.15 - Definition of term “insulin.”"
title_number: 21
title_name: "Food and Drugs"
section_number: "200.15"
section_name: "Definition of term “insulin.”"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "200"
part_name: "GENERAL"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360e, 371, 374, 375."
regulatory_source: "40 FR 13996, Mar. 27, 1975, unless otherwise noted."
cfr_part: "200"
---


# 200.15 Definition of term “insulin.”

For purposes of sections 801 and 802 of the act and this title, the term *insulin* means the active principle of the pancreas that affects the metabolism of carbohydrates in the animal body and which is of value in the treatment of diabetes mellitus. The term includes synthetic and biotechnologically derived products that are the same as, or similar to, naturally occurring insulins in structure, use, and intended effect and are of value in the treatment of diabetes mellitus.

[63 FR 26698, May 13, 1998]