• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1484]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1484 Neomycin.

(a) Specifications. (1) Each ounce of powder contains 20.3 grams (g) neomycin sulfate (equivalent to 14.2 g neomycin base).

(2) Each milliliter of solution contains 200 milligrams (mg) neomycin sulfate (equivalent to 140 mg neomycin base).

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) Nos. 054771 and 054925 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section.

(2) Nos. 016592, 054771, 058005, and 061133 for use of product described in paragraph (a)(1) as in paragraphs (e)(1) and (e)(2) of this section.

(3) Nos. 016592, 054771, 054925, and 058005 for use of product described in paragraph (a)(2) as in paragraph (e)(1) of this section.

(c) Related tolerances. See § 556.430 of this chapter.

(d) Special labeling considerations. Labeling shall bear the following warning statements: "A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues."

(e) Conditions of use - (1) Cattle, swine, sheep, and goats - (i) Amount. 10 mg per pound (/lb) of body weight per day (22 mg per kilogram (/kg)) in divided doses for a maximum of 14 days.

(ii) Indications for use. For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.

(iii) Limitations. Discontinue treatment prior to slaughter as follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Turkeys - (i) Amount. 10 mg/lb of body weight per day (22 mg/kg) for 5 days.

(ii) Indications for use. For the control of mortality associated with E. coli susceptible to neomycin sulfate in growing turkeys.

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

[71 FR 56866, Sept. 28, 2006, as amended at 71 FR 68738, Nov. 28, 2006; 78 FR 17596, Mar. 22, 2013; 78 FR 28825, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR 94989, Dec. 27, 2016; 84 FR 8973, Mar. 13, 2019]

-
-