[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.161]

[Page 222]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  522.161  Betamethasone acetate and betamethasone disodium phosphate aqueous suspension.

    (a) Chemical names. Betamethasone acetate: 9-[alpha]-Fluoro-16-
[beta]-methylprednisolone - 21 - acetate 
(C24H31FO6). Betamethasone disodium 
phosphate: 9-[alpha]-Fluoro-16-[beta]-methylprednisolone-21-disodium 
phosphate (C22H28FNa2O8P).
    (b) Specifications. The drug is a sterile aqueous suspension and 
each cubic centimeter contains: 12 milligrams of betamethasone acetate 
(equivalent to 10.8 milligrams of betamethasone), 3.9 milligrams of 
betamethasone disodium phosphate (equivalent to 3 milligrams of 
betamethasone), 2 milligrams of dibasic sodium phosphate, 5 milligrams 
of sodium chloride, 0.1 milligram of disodium EDTA, 0.5 milligram of 
polysorbate 80, 9 milligrams of benzyl alcohol, 5 milligrams of sodium 
carboxymethylcellulose, 1.8 milligrams of methylparaben, 0.2 milligram 
of propylparaben, hydrochloric acid and/or sodium hydroxide to adjust 
pH, and water for injection q.s.
    (c) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use. It is used or intended for use by intra-
articular injection of horses for the treatment of various inflammatory 
joint conditions; for example, acute and traumatic lameness involving 
the carpel and fetlock joints. Administer from 2.5 to 5 cubic 
centimeters per dose. Dose may be repeated when necessary depending upon 
the duration of relief obtained. Not for use in horses intended for 
food. For use only by or on the order of a licensed veterinarian.

[40 FR13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987]