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Electronic Code of Federal Regulations

e-CFR data is current as of December 4, 2019

Title 21Chapter ISubchapter EPart 522 → §522.163


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.163   Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension.

(a) Specifications. Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension is a sterile aqueous suspension. Each milliliter of the suspension contains the equivalent of 5 milligrams of betamethasone as betamethasone dipropionate and 2 milligrams of betamethasone as betamethasone sodium phosphate.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs. (i) It is used as an aid in the control of pruritus associated with dermatoses.

(ii) It is administered by intramuscular injection at a dosage of 0.25 to 0.5 milliliter per 20 pounds of body weight, depending on the severity of the condition. Frequency of dosage depends on recurrence of pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms recur, not to exceed a total of 4 injections.

(2) Horses. (i) It is used as an aid in the control of inflammation associated with various arthropathies.

(ii) It is administered aseptically by intraarticular injection at a dosage of 2.5 to 5 milliliters per joint, depending on the severity of the condition and the joint size. Dosage may be repeated upon recurrence of clinical signs. Injection into the joint cavity should be preceded by withdrawal of synovial fluid.

(iii) Not for use in horses intended for food.

(3) Clinical and experimental data. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(4) Restrictions. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 41 FR 27316, July 2, 1976; 52 FR 7832, Mar. 13, 1987]

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