21 CFR § 522.2120 - Spectinomycin hydrochloride.

---
identifier: "/us/cfr/t21/s522.2120"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.2120 - Spectinomycin hydrochloride."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.2120"
section_name: "Spectinomycin hydrochloride."
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"
---


# 522.2120 Spectinomycin hydrochloride.

(a) *Specifications.* Each milliliter of solution contains 100 milligrams (mg) spectinomycin hydrochloride (as spectinomycin dihydrochloride pentahydrate).

(b) *Sponsors.* See sponsors in § 510.600(c) of this chapter:

(1) Nos. 016592 and 054771 for use as in paragraph (d)(1) of this section; and

(2) No. 058198 for use as in paragraph (d)(2) of this section.

(c) *Related tolerances.* See § 556.600 of this chapter.

(d) *Conditions of use.* It is administered as follows:

(1) *Turkeys (1- to 3-day-old poults) and chickens (newly hatched chicks)*—(i) *Amounts and indications for use.* (A) Administer 5 mg per poult subcutaneously as an aid in the control of chronic respiratory disease (CRD) associated with *Escherichia coli* in 1- to 3-day-old turkey poults.

(B) Administer 10 mg per poult as a single subcutaneous injection in the nape of the neck as an aid in the control of airsacculitis associated with *Mycoplasma meleagridis* sensitive to spectinomycin in 1- to 3-day-old turkey poults.

(C) Administer 2.5 to 5 mg per chick as an aid in the control of mortality and to lessen severity of infections caused by *M. synoviae, Salmonella typhimurium, S. infantis,* and *E. coli.*

(ii) *Limitations.* For use only in 1- to 3-day-old turkey poults and newly hatched chicks. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) *Dogs*—(i) *Amount.* Administer 2.5 to 5.0 mg per pound of body weight by intramuscular injection twice daily. Treatment may be continued for 4 days.

(ii) *Indications for use.* For treatment of infections caused by gram-negative and gram-positive organisms susceptible to spectinomycin.

(iii) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[86 FR 14820, Mar. 19, 2021, as amended at 88 FR 27700, May 3, 2023]