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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 Nov 29, 2022.

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: 21CFR526.1590]



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. 526.1590 Novobiocin.

(a) Specifications. Each single-dose, 10-milliliter syringe contains:

(1) 150 milligrams (mg) of novobiocin equivalents as sodium novobiocin, or

(2) 400 mg of novobiocin equivalents as sodium novobiocin.

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

(c) Related tolerances. See § 556.460 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 150 mg novobiocin) into each infected quarter after milking. Repeat treatment once after 24 hours. Do not milk for at least 6 hours after treatment.

(2) Indications for use. For the treatment of mastitis caused by susceptible strains of Staphylococcus aureus in lactating cows.

(3) Limitations. Milk taken from treated animals within 72 hours (6 milkings) after latest treatment should not be used for food. Do not slaughter treated animals for food for 15 days following 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 dry cows - (1) Amount . Infuse the contents of one syringe (equivalent to 400 mg novobiocin) into each quarter at the time of drying off.

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

(3) Limitations. For udder installation for the treatment of mastitis in dry cows only. Infuse each quarter at the time of drying off, but not less than 30 days prior to calving. Do not slaughter treated animals for food for 30 days following udder infusion.

[86 FR 13187, Mar. 8, 2021]

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