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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1696b


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


§522.1696b   Penicillin G procaine aqueous suspension.

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

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter as follows:

(1) Nos. 016592, 054771, and 055529 for use as in paragraph (d) of this section.

(2) No. 061133 for use as in paragraph (d)(2) of this section.

(c) Related tolerances. See §556.510 of this chapter.

(d) Conditions of use—(1) Dogs and cats—(i) Amount. 10,000 units per pound body weight daily by intramuscular injection at 24-hour intervals. Continue treatment at least 48 hours after symptoms disappear.

(ii) Indications for use. Treatment of infections caused by penicillin-sensitive organisms.

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

(2) Cattle, sheep, swine, and horses—(i) Amount. 3,000 units per pound body weight (1 milliliter per 100 pounds body weight) daily by intramuscular injection.

(A) For Nos. 000859, 054771, 055529, and 061133: Continue treatment at least 48 hours after symptoms disappear.

(B) For No. 055529: Continue treatment at least 1 day after symptoms disappear (usually 2 or 3 days).

(ii) Indications for use. Treatment of cattle and sheep for bacterial pneumonia (shipping fever) caused by Pasteurella multocida; swine for erysipelas caused by Erysipelothrix rhusiopathiae; and horses for strangles caused by Streptococcus equi.

(iii) Limitations. Not for use in horses intended for food. Milk that has been taken during treatment and for 48 hours after the last treatment must not be used for food.

(A) For Nos. 054771 and 061133: Do not exceed 7 days of treatment in nonlactating dairy and beef cattle, sheep, and swine, or 5 days in lactating cattle. Discontinue treatment for the following number of days before slaughter: Nonruminating cattle (calves)—7; all other cattle—4; sheep—8; and swine—6.

(B) For Nos. 000859 and 055529: Continue treatment at least 1 day after symptoms disappear (usually 2 or 3 days).

[66 FR 712, Jan. 4, 2001, as amended at 68 FR 34534, June 10, 2003; 68 FR 42589, July 18, 2003; 69 FR 17586, Apr. 5, 2004; 70 FR 16935, Apr. 4, 2005; 73 FR 14177, Mar. 17, 2008; 75 FR 54017, Sept. 3, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR 16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 84 FR 8974, Mar. 13, 2019]

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