21 CFR 522.500

§ 522.500 Cosyntropin injection.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 522.500, § 522.500 Cosyntropin injection, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87413
Permanent ID: ys:prov:87413@1
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Full text

(a) Sponsor. See No. 043264 in § 510.600(c) of this chapter. (b) Specifications. Each milliliter (mL) contains 0.25 milligrams (mg) cosyntropin, 1 mg glacial acetic acid, 0.82 mg sodium acetate trihydrate, 8.1 mg sodium chloride, and water for injection (to 100%). (c) Conditions of use—(1) Amount. Administer 0.25 mg (1 mL) per dog weighing 10-110 pounds (4.5-50 kilograms) by intravenous or intramuscular injection. (2) Indications for use. For the evaluation of adrenal function in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.