---
kind: "section"
citation: "21 C.F.R. § 522.535"
title: "21"
number: "522.535"
heading: "Desoxycorticosterone."
url: "https://uscodex.org/cfr/21/522.535"
---

# §522.535. Desoxycorticosterone.

- (a) **Specifications.** Each milliliter of suspension contains 25 milligrams (mg) of desoxycorticosterone pivalate.
- (b) **Sponsors.** See sponsor numbers in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
  - (1) **No.** 043264 for use as in paragraphs [(c)(1)(i)](#c-1-i), [(c)(2)(i)](#c-2-i), and (c)(3) of this section.
  - (2) **No.** 058198 for use as in paragraphs [(c)(1)(ii)](#c-1-ii), [(c)(2)(ii)](#c-2-ii), and (c)(3) of this section.
- (c) **Conditions of use—**
  - (1) **Amount.**
    - (i) Administer an initial dose of 2.2 mg/kilogram (1 mg/lb) of body weight by subcutaneous injection. Subsequent dosages should be individualized according to label instructions based on patient response to therapy.
    - (ii) Dosage requirements are variable and must be individualized on the basis of the response of the patient to therapy. Initial dose of 1 milligram per pound (0.45 kilogram) of body weight every 25 days, intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days.
  - (2) **Indications for use—**
    - (i) For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison's Disease).
    - (ii) For use as replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[81 FR 22524, Apr. 18, 2016]

### Authority

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

### Source

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

### Amendments

[81 FR 22524, Apr. 18, 2016]