21 C.F.R. § 522.1696c   Penicillin G procaine in oil.


Title 21 - Food and Drugs


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

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§ 522.1696c   Penicillin G procaine in oil.

(a) Specifications. Each milliliter contains penicillin G procaine equivalent to 300,000 units of penicillin G.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) National Academy of Sciences/National Research Council (NAS/NRC) status. The conditions of use were NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information.

(d) Conditions of use—(1) Amount. Dogs and cats—10,000 units per pound of body weight once daily. Horses—3,000 units per pound of body weight once daily.

(2) Indications for use. Treatment of infections of dogs, cats, and horses caused by penicillin-susceptible organisms such as Streptococci, Staphylococci, and Corynebacteria.

(3) Limitations. Not for use in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37333, Aug. 18, 1992]

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