§522.480. Corticotropin.

21 C.F.R. § 522.480

(a)

Specifications. Each milliliter of aqueous solution contains 40 or 80 U.S.P. (I.U.) units of repository corticotropin.

(b)

Sponsor. See No. 061133 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.

Notes, amendments, and revision history

[79 FR 16185, Mar. 25, 2014, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 45308, July 28, 2020; 90 FR 40970, Aug. 22, 2025]

Authority: 21 U.S.C. 360b.

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

[79 FR 16185, Mar. 25, 2014, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 45308, July 28, 2020; 90 FR 40970, Aug. 22, 2025]