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: 21CFR522.2112]

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 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.2112 Sometribove zinc suspension.

(a) Specifications. Each single-dose syringe contains 500 milligrams (mg) sometribove zinc in a prolonged-release suspension.

(b) Sponsor. See No. 086106 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount. Inject 500 mg every 14 days starting during the 9th or 10th week (57 to 70 days) after calving and continue until the end of lactation.

(2) Indications for use. To increase production of marketable milk in healthy lactating dairy cows.

(3) Limitations. Use in lactating dairy cows only. Safety to replacement bulls born to treated dairy cows has not been established. Inject subcutaneously. Avoid injections within 2 weeks of expected slaughter to minimize injection site blemishes on carcass. There is no milk discard or preslaughter withdrawal period. Use may reduce pregnancy rates and increase days open. Treated cows are at an increased risk for mastitis and higher milk somatic cell counts. Use care to differentiate increased body temperature due to use of this product from an increased body temperature that may occur due to illness. Cows treated with this product may have more enlarged hocks and disorders of the foot region. Use may reduce hemoglobin and hematocrit values during treatment. Human warning: Avoid prolonged or repeated contact with eyes and skin.

[58 FR 59947, Nov. 12, 1993, as amended at 67 FR 18085, Apr. 15, 2002; 68 FR 62006, Oct. 31, 2003; 74 FR 53164, Oct. 16, 2009; 81 FR 48702, July 26, 2016; 85 FR 4208, Jan. 24, 2020]