21 CFR § 522.2632 - Tulathromycin and ketoprofen.

---
identifier: "/us/cfr/t21/s522.2632"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.2632 - Tulathromycin and ketoprofen."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.2632"
section_name: "Tulathromycin and ketoprofen."
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"
---


# 522.2632 Tulathromycin and ketoprofen.

(a) *Specifications.* Each milliliter of solution contains 100 milligrams (mg) tulathromycin and 120 milligrams (mg) ketoprofen.

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

(c) *Related tolerances.* See §§ 556.345 and 556.745 of this chapter.

(d) *Conditions of use*—(1) *Cattle*—(i) *Amount.* Administer as a single subcutaneous injection 2.5 mg tulathromycin and 3 mg ketoprofen per kilogram (1.1 mL/100 lb) of body weight.

(ii) *Indications for use.* For the treatment of bovine respiratory disease (BRD) associated with *Mannheimia haemolytica, Pasteurella multocida, Histophilus somni,* and *Mycoplasma bovis,* and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers.

(iii) *Limitations.* Not for use in reproducing animals over 1 year of age. Cattle must not be slaughtered for human consumption within 18 days following last treatment with this drug product. Not for use in female dairy cattle 1 year of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[86 FR 61685, Nov. 8, 2021]