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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Aug 30, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.480]



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

Sec. 522.480 Corticotropin.

(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. 043264 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.

[79 FR 16185, Mar. 25, 2014, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 45308, July 28, 2020]

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