21 CFR § 522.1684 - Pegbovigrastim.

---
identifier: "/us/cfr/t21/s522.1684"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.1684 - Pegbovigrastim."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.1684"
section_name: "Pegbovigrastim."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 522.1684 Pegbovigrastim.

(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.

[81 FR 36789, June 8, 2016, as amended at 81 FR 48702, July 26, 2016]