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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: 21CFR520.2380b]



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. 520.2380b Thiabendazole drench or paste.

(a) Specifications. Conforms to N.F. XII.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.730 of this chapter.

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

(1) Horses. As a single liquid oral dose, administered as a drench or by stomach tube; or as an oral paste.

(i) Amount. 2 grams per 100 pounds of body weight.

(a ) Indications for use. For the control of infections of large strongyles (Strongylus vulgaris, Strongylus endentatus ), small strongyles (Cyathastomum, Cylicobrachytus and related genera, Craterostomum, Oesophagodontus, Poteriostomum ), pinworms (Oxyuris ), and threadworms (Strongyloides ).

(b ) Limitations. Not for use in horses to be slaughtered for food purposes. When administered by stomach tube, for use only by or on the order of a licensed veterinarian. When for use as a liquid oral drench or an oral paste, consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(ii) Amount. 4 grams per 100 pounds of body weight.

(a ) Indications for use. For control of infections of ascardis (Parascaris ).

(b ) Limitations. Not for use in horses to be slaughtered for food purposes. When administered by stomach tube, use only by or on the order of a licensed veterinarian. When for use as a liquid oral drench or an oral paste, consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(2) Pigs. As an oral paste.

(i) Amount. 200 milligrams for each 5 to 7 pounds of body weight per dose.

(ii) Indications for use. For control of infections with Strongyloides ransomi. These infections are commonly found in Southeastern United States.

(iii) Limitations. Administer to baby pigs (1 to 8 weeks of age). Treatment may be repeated in 5 to 7 days if necessary. Before treatment, obtain an accurate diagnosis from a veterinarian or diagnostic laboratory. Do not treat within 30 days of slaughter.

(3) Cattle. Orally as a drench and in paste form using a dosing gun designed for the product.

(i) Amount. 3 grams per 100 pounds of body weight.

(a ) Indications for use. Control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Nematodirus spp., Ostertagia spp., and Oesophagostomum radiatum ).

(b ) Limitations. For most effective results, severely parasitized animals or those constantly exposed to helminth infection should be re-treated every 2 to 3 weeks. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle within 3 days of slaughter. For a satisfactory diagnosis, a microscopic fecal examination should be performed prior to worming.

(ii) Amount. 5 grams per 100 pounds of body weight.

(a ) Indications for use. Control of infections of Cooperia spp. or severe infections of other species in paragraph (e)(3)(i)(a ) of this section.

(b ) Limitations. For most effective results, severely parasitized animals or those constantly exposed to helminth infection should be re-treated every 2 to 3 weeks. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. Do not treat cattle within 3 days of slaughter. For a satisfactory diagnosis, a microscopic fecal examination should be performed prior to worming.

(4) Sheep and goats. Orally, as a drench.

(i) Amount. 2 grams per 100 pounds of body weight.

(ii) Indications for use. Control of infections of gastrointestinal roundworms in sheep and goats. (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ); also active from 3 hours to 3 days following treatment against ova and larvae passed by sheep (good activity against Trichostrongylus colubriformis and axei, Ostertagia spp., Bunostomum spp., Nematodirus spp., and Strongyloides spp.; less effective against Haemonchus contortus and Oesophagostomum spp. ).

(iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; in severe infections in sheep, treatment should be repeated in 2 to 3 weeks.

(5) Goats. Orally, as a drench.

(i) Amount. 3 grams per 100 pounds of body weight.

(ii) Indications for use. Control of severe infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp. ).

(iii) Limitations. As a single oral dose; do not treat animals within 30 days of slaughter; milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food; treatment should be repeated in 2 to 3 weeks.

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 9149, Mar. 3, 1976; 41 FR 47424, Oct. 29, 1976; 62 FR 63271, Nov. 28, 1997; 79 FR 28832, May 20, 2014; 84 FR 39183, Aug. 9, 2019]

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