Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 522  /  Sec. 522.1696 Penicillin G procaine injectable dosage forms. Sec. 522.1696a Penicillin G benzathine and penicillin G procaine suspension.

(a) Specifications. Each milliliter of aqueous suspension contains penicillin G benzathine and penicillin G procaine, each equivalent to 150,000 units of penicillin G.

(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for the conditions of use in paragraph (d) of this section as follows:

(1) Nos. 054771, 055529, and 061623 for use as in paragraph (d)(1) of this section.

(2) Nos. 000859, 055529, and 061623 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(2)(iii) of this section.

(3) No. 054771 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(B), and (d)(2)(iii) of this section.

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

(d) Conditions of use--(1) Horses, dogs, and beef cattle--(i) Amount--(A) Beef cattle. 2 milliliters per 150 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours.

(1) Horses, dogs, and beef cattle--(i) Amount--(A) Beef cattle. 2 milliliters per 150 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours.

(i) Amount--(A) Beef cattle. 2 milliliters per 150 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours.

(A) Beef cattle. 2 milliliters per 150 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours.

(B) Horses. 2 milliliters per 150 pounds of body weight intramuscularly. Repeat dosage in 48 hours.

(C) Dogs. 1 milliliter per 10 to 25 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours.

(ii) Conditions of use. Treatment of bacterial infections susceptible to penicillin G.

(iii) Limitations. Not for use in beef cattle within 30 days of slaughter. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Beef cattle--(i) Amount. 2 milliliters per 150 pounds of body weight subcutaneously. Repeat dosage in 48 hours.

(i) Amount. 2 milliliters per 150 pounds of body weight subcutaneously. Repeat dosage in 48 hours.

(ii) Conditions of use. (A) Treatment of bacterial pneumonia (Streptococcus spp., Actinomyces pyogenes, Staphylococcus aureus); upper respiratory infections such as rhinitis or pharyngitis (A. pyogenes); blackleg (Clostridium chauvoei).

(A) Treatment of bacterial pneumonia (Streptococcus spp., Actinomyces pyogenes, Staphylococcus aureus); upper respiratory infections such as rhinitis or pharyngitis (A. pyogenes); blackleg (Clostridium chauvoei).

(B) As in paragraph (d)(2)(ii)(A) of this section; and prophylaxis of bovine shipping fever in 300- to 500-pound beef calves.

(iii) Limitations. Not for use within 30 days of slaughter. For Nos. 000859, 055529, and 061623: A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. [66 FR 711, Jan. 4, 2001, as amended at 68 FR 34534, June 10, 2003; 70 FR 21947, Apr. 28, 2005; 70 FR 50182, Aug. 26, 2005; 73 FR 16754, Mar. 31, 2008; 75 FR 54017, Sept. 3, 2010; 77 FR 4897, Feb. 1, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR 16192, Mar. 25, 2014] Sec. 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 Sec. 510.600(c) of this chapter as follows:

(1) Nos. 000859, 054771, and 055529 for use as in paragraph (d) of this section.

(2) No. 061623 for use as in paragraph (d)(2) of this section.

(c) Related tolerances. See Sec. 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.

(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.

(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.

(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 061623: 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 061623: 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] Sec. 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. 054771 in Sec. 510.600(c) of this chapter.

(c) 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.

(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, as amended at 79 FR 16193, Mar. 25, 2014]