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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.1696a]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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 § 510.600(c) of this chapter for the conditions of use in paragraph (d) of this section as follows:

(1) Nos. 054771 and 061133 for use as in paragraph (d)(1) of this section.

(2) Nos. 016592 and 061133 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 § 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.

(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) Indications for 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.

(ii) Indications for 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 ).

(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 No. 016592: A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. For No. 016592: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[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; 81 FR 22524, Apr. 18, 2016; 84 FR 8974, Mar. 13, 2019; 85 FR 18120, Apr. 1, 2020; 88 FR 16548, Mar. 20, 2023]

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