subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "526"
part_subject: "INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "526.1696d"
section_subject: "Penicillin G procaine-novobiocin for intramammary infusion."
cfr_reference: "21 CFR 526.1696d"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. For lactating cattle: each 10-milliliter dose contains 100,000 units of penicillin G procaine and 150 milligrams of novobiocin as novobiocin sodium. For dry cows: 200,000 units of penicillin G procaine and 400 milligrams of novobiocin as novobiocin sodium.
(b)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c)Conditions of use—(1) Lactating cows—(i) Amount. 10 milliliters in each infected quarter after milking. Repeat once after 24 hours.
(ii)Indications for use. Treating lactating cows for mastitis caused by susceptible strains of Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis.
(iii)Limitations. For udder instillation in lactating cattle 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. If redness, swelling, or abnormal milk persists, discontinue use and consult a veterinarian.
(2)Dry cows—(i) Amount. 10 milliliters in each quarter at time of drying off.
(ii)Indications for use. Treatment of subclinical mastitis caused by susceptible strains of Staphylococcus aureus and Streptococcus agalactiae.
(iii)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.