21 CFR § 522.500 - Cosyntropin injection.

---
identifier: "/us/cfr/t21/s522.500"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.500 - Cosyntropin injection."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.500"
section_name: "Cosyntropin injection."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-16"
last_updated: "2026-04-16"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 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]