§522.1696b. Penicillin G procaine aqueous suspension.
21 C.F.R. § 522.1696b
Specifications. Each milliliter contains penicillin G procaine equivalent to 300,000 units of penicillin G.
Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows:
Nos. 016592 and 054771 for use as in paragraph (d) of this section.
Nos. 055529 and 061133 for use as in paragraph (d)(2) of this section.
Related tolerances. See § 556.510 of this chapter.
Conditions of use—
Dogs and cats—
Amount. 10,000 units per pound body weight daily by intramuscular injection.
Indications for use. Treatment of infections caused by penicillin-sensitive organisms.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cattle, sheep, swine, and horses—
Amount. 3,000 units per pound body weight (1 milliliter per 100 pounds body weight) daily by intramuscular injection.
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.
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.
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.
For Nos. 016592 and 055529: treatment should not exceed 4 consecutive days. A withdrawal period has not been established for this product in pre-ruminating calves. Discontinue treatment for the following number of days before slaughter: cattle—14; sheep—9; and swine—7.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[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; 85 FR 18120, Apr. 1, 2020; 88 FR 14899, Mar. 10, 2023; 88 FR 16548, Mar. 20, 2023; 88 FR 27700, May 3, 2023; 89 FR 85427, Oct. 28, 2024]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
Amendments
[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; 85 FR 18120, Apr. 1, 2020; 88 FR 14899, Mar. 10, 2023; 88 FR 16548, Mar. 20, 2023; 88 FR 27700, May 3, 2023; 89 FR 85427, Oct. 28, 2024]