---
kind: "section"
citation: "21 C.F.R. § 522.1696b"
title: "21"
number: "522.1696b"
heading: "Penicillin G procaine aqueous suspension."
url: "https://uscodex.org/cfr/21/522.1696b"
---

# §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)](/cfr/21/510.600.md?p=c) of this chapter as follows:
  - (1) **Nos.** 016592 and 054771 for use as in [paragraph (d)](#d) of this section.
  - (2) **Nos.** 055529 and 061133 for use as in [paragraph (d)(2)](#d-2) of this section.
- (c) **Related tolerances.** See [§ 556.510](/cfr/21/556.510.md) of this chapter.
- (d) **Conditions of use—**
  - (1) **Dogs and cats—**
    - (i) **Amount.** 10,000 units per pound body weight daily by intramuscular injection.
    - (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.
    - (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.** 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.
      - (C) **Federal law restricts this drug to use by or on the order of a licensed veterinarian.**

## Notes

### 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]