21 CFR 522.2120 - Spectinomycin dihydrochloride injection.

§ 522.2120 Spectinomycin dihydrochloride injection.

(a)Specifications. The spectinomycin dihydrochloride pentahydrate used in manufacturing the drug is the antibiotic substance produced by the growth of Streptomyces flavopersicus (var. Abbott) or the same antibiotic substance produced by any other means. Each milliliter of the drug contains the following amount of spectinomycin activity from spectinomycin dihydrochloride pentahydrate:

(1) 5 milligrams when used as provided in paragraph (d)(1) of this section.

(2) [Reserved]

(3) 100 milligrams when used as provided in paragraphs (d) (2), (3), and (4) of this section.

(b)Sponsor. In § 510.600 of this chapter, see No. 016592 for conditions of use as in paragraph (d) of this section, and see No. 054771 for conditions of use as in paragraph (d)(2) and (d)(4) of this section.

(c)Special considerations. The quantity of spectinomycin referred to in this section refers to the equivalent weight of base activity for the drug.

(d)Conditions of use. It is administered as spectinomycin dihydrochloride pentahydrate as follows:

(1) Subcutaneously in the treatment of 1-to-3-day-old turkey poults at the rate of 1 to 2 milligrams per poult as an aid in the prevention of mortality associated with Arizona group infection.

(2) Subcutaneously in the treatment of 1-to-3-day old:

(i) Turkey poults at the rate of 5 milligrams per poult as an aid in the control of chronic respiratory disease (CRD) associated with E. coli.

(ii) Baby chicks at the rate of 2.5 to 5 milligrams per chick as an aid in the control of mortality and to lessen severity of infections caused by M. synoviae, S. typhimurium, S. infantis, and E. coli.

(3) Intramuscularly in the treatment of dogs:

(i) At a dosage level of 2.5 milligrams to 5.0 milligrams per pound of body weight twice daily. Treatment may be continued for 4 days. For treatment of infections caused by gram-negative and gram-positive organisms susceptible to spectinomycin.

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

(4) Administer single injection of 0.1 milliliter (10 milligrams) subcutaneously in nape of neck of 1- to 3-day-old turkey poults as an aid in control of airsacculitis associated with M. meleagridis sensitive to spectinomycin.

[ 40 FR 13858, Mar. 27, 1975, as amended at 43 FR 9273, Mar. 7, 1978; 46 FR 18964, Mar. 27, 1981; 47 FR 14149, Apr. 2, 1982; 61 FR 5507, Feb. 13, 1996; 61 FR 31028, June 19, 1996; 65 FR 45877, July 26, 2000; 66 FR 22118, May 3, 2001; 79 FR 16195, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2017-03-01; vol. 82 # 39 - Wednesday, March 1, 2017
    1. 82 FR 12167 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective March 1, 2017, except for amendments 2.a and 2.c to 21 CFR 510.600, and the amendments to 21 CFR 522.313c and 529.1186, which are effective March 13, 2017.
      21 CFR Parts 510, 516, 520, 522, 529, and 558