21 CFR § 526.88 - Amoxicillin.

---
identifier: "/us/cfr/t21/s526.88"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 526.88 - Amoxicillin."
title_number: 21
title_name: "Food and Drugs"
section_number: "526.88"
section_name: "Amoxicillin."
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: "526"
part_name: "INTRAMAMMARY 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."
cfr_part: "526"
---


# 526.88 Amoxicillin.

(a) *Specifications.* Each single-dose, 10-milliliter syringe contains amoxicillin trihydrate equivalent to 62.5 milligrams (mg) amoxicillin.

(b) *Sponsor.* See No. 000061 in § 510.600(c) of this chapter.

(c) *Related tolerances.* See § 556.38 of this chapter.

(d) *Conditions of use in lactating cows*—(1) *Amount.* Infuse the contents of one syringe (equivalent to 62.5 mg amoxicillin) into each infected quarter every 12 hours for a maximum of 3 doses.

(2) *Indications for use.* For the treatment of subclinical infectious bovine mastitis due to *Streptococcus agalactiae* and *Straphylococcus aureus* (penicillin sensitive).

(3) *Limitations.* Milk taken from animals during treatment and for 60 hours (5 milkings) after the last treatment must not be used for food. Treated animals must not be slaughtered for food purposes within 12 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37334, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, 2003; 86 FR 13185, Mar. 8, 2021]