StacksVerified U.S. regulatory reference

21 CFR §522.454

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each milliliter of solution contains 60 milligrams (mg) clodronate disodium.
  2. (b)Sponsor. See No. 043264 in § 510.600(c) of this chapter.
  3. (c)Conditions of use in horses—(1) Amount. Administer 1.8 mg per kilogram of body weight by intramuscular injection up to a maximum dose of 900 mg per horse.
    1. (2)Indications for use. For the control of clinical signs associated with navicular syndrome.
    2. (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.