21 CFR § 522.1055 - Gleptoferron.

---
identifier: "/us/cfr/t21/s522.1055"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.1055 - Gleptoferron."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.1055"
section_name: "Gleptoferron."
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"
---


# 522.1055 Gleptoferron.

(a) *Specifications.* Each milliliter (mL) contains the equivalent of 200 milligrams of elemental iron as gleptoferron, a complex of ferric hydroxide and dextran glucoheptonic acid.

(b) *Sponsors.* See No. 013744 in § 510.600(c) of this chapter.

(c) *Conditions of use in swine*—(1) *Indications for use and amounts.* (i) Prevention of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection on or before 3 days of age.

(ii) Treatment of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection as soon as signs of deficiency appear.

(2) [Reserved]

[81 FR 59134, Aug. 29, 2016, as amended at 82 FR 11508, Feb. 24, 2017; 82 FR 21690, May 10, 2017]