21 CFR § 522.167 - Betamethasone sodium phosphate and betamethasone acetate.

---
identifier: "/us/cfr/t21/s522.167"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.167 - Betamethasone sodium phosphate and betamethasone acetate."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.167"
section_name: "Betamethasone sodium phosphate and betamethasone acetate."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 522.167 Betamethasone sodium phosphate and betamethasone acetate.

(a) *Specifications.* Each milliliter (mL) of suspension contains 6 milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate and 2.85 mg betamethasone acetate).

(b) *Sponsor.* See No. 010797 in § 510.600(c) of this chapter.

(c) *Conditions of use in horses*—(1) *Amount.* Administer 1.5 mL (9 mg total betamethasone) per joint by intra-articular injection. May be administered concurrently in up to two joints per horse.

(2) *Indications for use.* For the control of pain and inflammation associated with osteoarthritis in horses.

(3) *Limitations.* Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[80 FR 18776, Apr. 8, 2015]