GroundRules
21 CFR 522.500: Cosyntropin injection.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
- PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON