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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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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).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.38a]



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. 520.38a Albendazole suspension.

(a) Specifications. Each milliliter of suspension contains 45.5 milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole.

(b) Sponsor. See No. 054771 in § 510.600 of this chapter.

(c) Related tolerances. See § 556.34 of this chapter.

(d) Special considerations. See § 500.25 of this chapter.

(e) Conditions of use - (1) Cattle. Administer 11.36 percent suspension:

(i) Amount. 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as a single oral dose using dosing gun or dosing syringe.

(ii) Indications for use. For removal and control of adult liver flukes (Fasciola hepatica ); heads and segments of tapeworms (Moniezia benedeni and M. expansa ); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae (Ostertagia ostertagi ), barberpole worm (Haemonchus contortus and H. placei ), small stomach worm (Trichostrongylus axei )); adult and 4th stage larvae of intestinal worms (thread-necked intestinal worm (Nematodirus spathiger and N. helvetianus ), small intestinal worm (Cooperia punctata and C. oncophora )); adult stages of intestinal worms (hookworm (Bunostomum phlebotomum ), bankrupt worm (Trichostrongylus colubriformis ), nodular worm (Oesophagostomum radiatum )); adult and 4th stage larvae of lungworms (Dictyocaulus viviparus ).

(iii) Limitations. Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breeding age: Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls.

(2) Sheep. Administer 4.45 or 11.36 percent suspension:

(i) Amount. 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose using dosing gun or dosing syringe.

(ii) Indications for use. For removal and control of adult liver flukes (Fasciola hepatica and Fascioloides magna ); heads and segments of common tapeworms (Moniezia expansa ) and fringed tapeworm (Thysanosoma actinioides ); adult and fourth stage larvae of stomach worms (brown stomach worm (Ostertagia circumcinta and Marshallagia marshalli ), barberpole worm (Haemonchus contortus ), small stomach worm (Trichostrongylus axei )); adult and fourth stage larvae of intestinal worms (thread-necked intestinal worm (Nematodirus spathiger and N. filicollis ), Cooper's worm (Cooperia oncophora ), bankrupt worm (Trichostrongylus colubriformis ), nodular worm (Oesophagostomum columbianum ), and large-mouth bowel worm (Chabertia ovina )); adult and larval stages of lungworms (Dictyocaulus filaria ).

(iii) Limitations. Do not slaughter within 7 days of last treatment. Do not administer to ewes during first 30 days of pregnancy or for 30 days after removal of rams.

(3) Goats. Administer 11.36 percent suspension:

(i) Amount. 4.54 mg/lb body weight (10 mg/kg) as a single oral dose using dosing gun or dosing syringe.

(ii) Indications for use. For the treatment of adult liver flukes (Fasciola hepatica ) in nonlactating goats.

(iii) Limitations. Do not slaughter within 7 days of last treatment. Do not administer to does during the first 30 days of pregnancy or for 30 days after removal of bucks.

[73 FR 11027, Feb. 29, 2008. Redesignated at 78 FR 66264, Nov. 5, 2013, as amended at 79 FR 28816, May 20, 2014]

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