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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: 21CFR526.1697]



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. 526.1697 Penicillin G procaine and dihydrostreptomycin.

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

(1) Penicillin G procaine equivalent to 200,000 units penicillin G and dihydrostreptomycin sulfate equivalent to 300 milligrams dihydrostreptomycin; or

(2) Penicillin G procaine equivalent to 1 million units penicillin G and dihydrostreptomycin sulfate equivalent to 1 gram dihydrostreptomycin.

(b) Sponsor. See No. 042791 in § 510.600(c) of this chapter.

(c) Related tolerances. See §§ 556.200 and 556.510 of this chapter.

(d) Conditions of use for syringe described in paragraph (a)(1) of this section in dry cows - (1) Amount . Infuse the contents of one syringe (equivalent to 200,000 units penicillin G and 300 milligrams dihydrostreptomycin) into each quarter at the last milking prior to drying off.

(2) Indications for use. For the treatment of subclinical mastitis in dairy cows at the time of drying off, specifically against infections caused by Staphylococcus aureus and Streptococcus agalactiae .

(3) Limitations. For use in dry cows only. Not to be used within 6 weeks of calving. Milk taken from cows within 24 hours (2 milkings) after calving must not be used for food. Animals infused with this drug must not be slaughtered for food within 60 days of treatment or within 24 hours after calving. 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 1 million units penicillin G and 1 gram dihydrostreptomycin) into each quarter at the last milking prior to drying off.

(2) Indications for use. To reduce the frequency of existing infection and to prevent new infections with Staphylococcus aureus in dry cows.

(3) Limitations. Not for use in lactating cows. Not to be used within 6 weeks of calving. Milk taken from cows within 96 hours (8 milkings) after calving must not be used for food. Animals infused with this drug must not be slaughtered for food within 60 days from the time of infusion or within 96 hours after calving. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37336, Aug. 18, 1992, as amended at 78 FR 21060, Apr. 9, 2013; 83 FR 14587, Apr. 5, 2018. Redesignated and amended at 86 FR 13187, Mar. 8, 2021; 88 FR 55567, Aug. 16, 2023]

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