§ 522.1684 Pegbovigrastim.
Primary source
Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
Full Text
Specifications.(a) Each pre-filled, single-dose syringe contains 15 milligrams of pegbovigrastim.
Sponsor.(b) See No. 058198 in § 510.600(c) of this chapter.
Conditions of use in cattleAmount.(c) —(1) 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.
Indications for use.(2) 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.
Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[81 FR 36789, June 8, 2016, as amended at 81 FR 48702, July 26, 2016]
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.