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e-CFR data is current as of February 26, 2021

Title 21Chapter ISubchapter CPart 200Subpart A → §200.15

Title 21: Food and Drugs
Subpart A—General Provisions

§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]

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