subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "522"
part_subject: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "522.480"
section_subject: "Corticotropin."
cfr_reference: "21 CFR 522.480"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. Each milliliter of aqueous solution contains 40 or 80 U.S.P. (I.U.) units of repository corticotropin.
(b)Sponsor. See sponsors in § 510.600(c) of this chapter.
(1)No. 061133 for use as in paragraphs (c)(1) and (2) of this section.
(2)No. 026637 for use as in paragraph (c)(2) and (3) of this section.
(c)Conditions of use—(1) Dogs—(i) Amount. Administer one unit per pound of body weight by intramuscular injection.
(ii)Indications for use. As a diagnostic aid to test for adrenal dysfunction.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2)Dogs and cats—(i) Amount. Administer one unit per pound of body weight by intramuscular or subcutaneous injection, to be repeated as indicated.
(ii)Indications for use. For stimulation of the adrenal cortex where there is a general deficiency of corticotropin (ACTH).
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3)Cattle—(i) Amount. Administer 200 to 600 units by intramuscular or subcutaneous injection as an initial dose, followed by a dose daily or every other day of 200 to 300 units.
(ii)Indications for use. As a therapeutic agent for primary bovine ketosis; and for stimulation of the adrenal cortex where there is a general deficiency of ACTH.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.