Regulations last checked for updates: Apr 23, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 522.500 - Cosyntropin injection.

(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.

[91 FR 20342, Apr. 16, 2026]
authority: 21 U.S.C. 360b.
source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 522.500