21 CFR 522.1720 - Phenylbutazone injection.

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§ 522.1720 Phenylbutazone injection.
(a) Specifications. The drug contains 100 or 200 milligrams of phenylbutazone in each milliliter of sterile aqueous solution.
(b) Sponsors.
(1) Approval for use of the 200 milligrams per milliliter drug in dogs and horses: See sponsor Nos. 000061, 000856, 000859, and 061623 in § 510.600(c) of this chapter.
(2) Approval for use of the 200 milligrams per milliliter drug for use in horses: See sponsor Nos. 000010 and 058005 in § 510.600(c) of this chapter.
(3) Approval for use of the 100 milligrams per milliliter drug in dogs and horses: See sponsor No. 000856 in § 510.600(c) of this chapter.
(c) Conditions of use for dogs.
(1) It is used for the relief of inflammatory conditions associated with the musculoskeletal system.
(2) It is administered intravenously at a dosage level of 10 milligrams per pound of body weight daily in 3 divided doses, not to exceed 800 milligrams daily regardless of weight. Limit intravenous administration to 2 successive days. Oral medication may follow.
(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use for horses.
(1) It is used for the relief of inflammatory conditions associated with the musculoskeletal system.
(2) It is administered intravenously at a dosage level of 1 to 2 grams per 1,000 pounds of body weight daily in 3 divided doses, not to exceed 4 grams daily. Limit intravenous administration to not more than 5 successive days.
(3) Not for use in animals intended for food.
(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975]
Editorial Note:
For Federal Register citations affecting § 522.1720, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

Title 21 published on 2014-04-01

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

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558

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

Title 21 published on 2014-04-01

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

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558