• 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: 21CFR520.1630]



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. 520.1630 Oxfendazole suspension.

(a) Specifications. Each milliliter of suspension contains:

(1) 90.6 milligrams (mg) oxfendazole (9.06 percent).

(2) 225.0 mg oxfendazole (22.5 percent).

(b) Sponsor. See Nos. 000010 and 054771 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.495 of this chapter.

(d) Special considerations. See § 500.25 of this chapter. If labeled for administration by stomach tube: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e) Conditions of use - (1) Horses. Use the product described in paragraph (a)(1) of this section as follows:

(i) Amount. 10 mg per kilogram (/kg) of body weight by stomach tube or dose syringe. Horses maintained on premises where reinfection is likely to occur should be retreated in 6 to 8 weeks.

(ii) Indications for use. For removal of large roundworms (Parascaris equorum ), mature and 4th stage larvae pinworms (Oxyuris equi ), large strongyles (Strongylus edentatus, S. vulgaris, and S. equinus ), and small strongyles.

(iii) Limitations. Withholding feed or water prior to use is unnecessary. Administer drug with caution to sick or debilitated horses. Do not use in horses intended for human consumption.

(2) Cattle. Use the products described in paragraphs (a)(1) and (a)(2) of this section as follows:

(i) Amount. 4.5 mg/kg of body weight by dose syringe. Treatment may be repeated in 4 to 6 weeks.

(ii) Indications for use. For the removal and control of: lungworms (Dictyocaulus viviparus - adult, L4); stomach worms: barberpole worms (Haemonchus contortus and H. placei - adult), small stomach worms (Trichostrongylus axei - adult), brown stomach worms (Ostertagia ostertagi - adult, L4, inhibited L4); intestinal worms; nodular worms (Oesophagostomum radiatum - adult), hookworms (Bunostomum phlebotomum - adult), small intestinal worms (Cooperia punctata, C. oncophora, and C. surnabada - adult, L4), and tapeworms (Moniezia benedeni - adult).

(iii) Limitations. Cattle must not be slaughtered until 7 days after treatment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age.

[55 FR 46943, Nov. 8, 1990, as amended at 56 FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996; 72 FR 10596, Mar. 9, 2007; 73 FR 45610, Aug. 6, 2008; 75 FR 10166, Mar. 5, 2010; 78 FR 28825, May 20, 2014]

-
-