21 CFR 522.161 - Betamethasone acetate and betamethasone disodium phosphate aqueous suspension.

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§ 522.161 Betamethasone acetate and betamethasone disodium phosphate aqueous suspension.
(a) Chemical names. Betamethasone acetate: 9-α-Fluoro-16-β-methylprednisolone - 21 - acetate (C24H31FO6). Betamethasone disodium phosphate: 9-α-Fluoro-16-β-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 § 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]

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

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  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 522 after this date.

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522