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§ 522.500 Cosyntropin injection.

21 CFR 522.500

Citation21 CFR 522.500
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 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]