CFR - Code of Federal Regulations Title 21

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR526.1810]

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. 526.1810 Pirlimycin.

(a) Specifications. Each single-dose, 10-milliliter syringe contains 50 milligrams (mg) of pirlimycin (as pirlimycin hydrochloride).

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

(c) Related tolerances. See § 556.515 of this chapter.

(d) Conditions of use in lactating cows - (1) Amount. Infuse the contents of one syringe (50 mg pirlimycin) into each infected quarter. Daily treatment may be repeated at 24-hour intervals for up to 8 consecutive days.

(2) Indications for use. For the treatment of clinical and subclinical mastitis in lactating dairy cattle associated with Staphylococcus species such as Staphylococcus aureus and Streptococcus species such as Streptococcus agalactiae , Streptococcus dysgalactiae , and Streptococcus uberis.

(3) Limitations. Milk taken from animals during treatment and for 36 hours following the last treatment must not be used for food regardless of treatment duration. Following infusion twice at a 24-hour interval, treated animals must not be slaughtered for 9 days. Following any extended duration of therapy (infusion longer than twice at a 24-hour interval, up to 8 consecutive days), animals must not be slaughtered for 21 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[58 FR 58486, Nov. 2, 1993, as amended at 65 FR 61091, Oct. 16, 2000; 73 FR 811, Jan. 4, 2008; 79 FR 10973, Feb. 27, 2014; 86 FR 13188, Mar. 8, 2021]