eCFR Reference Browser

---

title: "21 CFR §520.2215"

source: "https://www.ecfr.gov/current/title-21/section-520.2215"

title_number: "21"

volume_number: "6"

chapter_number: "Unknown"

subchapter_code: "E"

subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"

part_code: "520"

part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"

subpart_code: "B"

subpart_subject: "Specific Administrative Rulings and Decisions"

section_number: "520.2215"

section_subject: "Sulfadiazine/pyrimethamine suspension."

cfr_reference: "21 CFR 520.2215"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 500 to 599"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Specifications. Each milliliter (mL) of suspension contains 250 milligrams (mg) sulfadiazine (as the sodium salt) and 12.5 mg pyrimethamine.

(b)Sponsor. See No. 055246 in § 510.600(c) of this chapter.

(c)Conditions of use in horses—(1) Amount. Administer orally 20 mg sulfadiazine per kilogram (kg) body weight and 1 mg/kg pyrimethamine daily.

(2)Indications for use. For the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.

(3)Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

§520.2215 - Sulfadiazine/pyrimethamine suspension.