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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: 21CFR526.1698]



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 526 -- INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

Sec. 526.1698 Penicillin G procaine and novobiocin.

(a) Specifications. Each single-use, 10-milliliter syringe contains a suspension of:

(1) Penicillin G procaine equivalent to 100,000 units penicillin G and 150 milligrams (mg) novobiocin as novobiocin sodium; or

(2) Penicillin G procaine equivalent to 200,000 units penicillin G and 400 mg novobiocin as novobiocin sodium.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See §§ 556.460 and 556.510 of this chapter.

(d) Conditions of use for syringe described in paragraph (a)(1) of this section in lactating cows - (1) Amount. Infuse the contents of one syringe (equivalent to 100,000 units penicillin G and 150 mg novobiocin) into each infected quarter after milking. Repeat once after 24 hours.

(2) Indications for use. For the treatment of mastitis caused by susceptible strains of Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis in lactating cows.

(3) Limitations. For udder instillation in lactating cows only. Do not milk for at least 6 hours after treatment; thereafter, milk at regular intervals. Milk taken from treated animals within 72 hours (6 milkings) after the latest treatment must not be used for food. Treated animals must not be slaughtered for food for 15 days following the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e) Conditions of use for syringe described in paragraph (a)(2) of this section in lactating cows - (1) Amount. Infuse the contents of one syringe (equivalent to 200,000 units penicillin G and 400 mg novobiocin) into each quarter at dry off.

(2) Indications for use. For the treatment of subclinical mastitis caused by susceptible strains of Staphylococcus aureus and Streptococcus agalactiae in dry cows.

(3) Limitations. For udder instillation in dry cows only. Do not use less than 30 days prior to calving. Milk from treated cows must not be used for food during the first 72 hours after calving. Treated animals must not be slaughtered for food for 30 days following udder infusion. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 79 FR 10973, Feb. 27, 2014; 84 FR 32993, July 11, 2019. Redesignated and amended at 86 FR 13187, Mar. 8, 2021; 88 FR 14901, Mar. 10, 2023]

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