21 CFR 522.1684
§ 522.1684 Pegbovigrastim.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 522.1684, § 522.1684 Pegbovigrastim, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87502
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Full text
(a) Specifications. Each pre-filled, single-dose syringe contains 15 milligrams of pegbovigrastim.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use in cattle—(1) Amount. Administer the first dose (syringe) by subcutaneous injection 7 days prior to the cow's or heifer's anticipated calving date. If necessary, the first dose may be administered within a range of 4 to 10 days prior to the anticipated calving date to accommodate management schedules. Administer the second dose (syringe) by subcutaneous injection within 24 hours after calving.
(2) Indications for use. For the reduction in the incidence of clinical mastitis in the first 30 days of lactation in periparturient dairy cows and periparturient replacement dairy heifers.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.