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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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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1242a]



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. 520.1242a Levamisole powder.

(a) Specifications. Each package of powder contains 9.075, 11.7, 18.15, 46.8, 362.7, or 544.5 grams (g) levamisole hydrochloride.

(b) Sponsors. See sponsors in § 510.600(c) for use as follows:

(1) No. 000061 for use of 46.8- and 544.5-g packages as in paragraph (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section; for 11.7-, 46.8-, and 544.5-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for an 18.15-g package as in paragraph (e)(3) of this section.

(2) No. 054771 for use of a 46.8-g package as in paragraph (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section; for 11.7- and 46.8-g packages as in paragraph (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section; and for 9.075- and 18.15-g packages as in paragraph (e)(3) of this section.

(3) No. 016592 for use of 46.8- and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) and (e)(2)(i), (e)(2)(ii)(A), and (e)(2)(iii) of this section.

(4) No. 061133 for use of 46.8-, 362.7-, and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), (e)(1)(iii), (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section; and for use of an 18.15-g package as in paragraph (e)(3) of this section.

(c) Related tolerances. See § 556.350 of this chapter.

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

(e) Conditions of use. It is used as an anthelmintic as follows:

(1) Cattle - (i) Amount. 8 milligrams per kilogram (mg/kg) body weight as a drench.

(ii) Indications for use. (A) Effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia ); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum ); and lungworms (Dictyocaulus ).

(B) Effective against the following adult nematode infections: Stomach worms (Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei ); intestinal worms (T. longispicularis, Cooperia oncophora, C. punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum ); and lungworms (Dictyocaulus viviparus ).

(iii) Limitations. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breeding age. Conditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Consult your veterinarian before using in severely debilitated animals.

(2) Sheep - (i) Amount. 8 mg/kg body weight as a drench.

(ii) Indications for use. (A) Effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia ); intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia ); and lungworms (Dictyocaulus ).

(B) Effective against the following adult nematode infections: Stomach worms (Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta ); intestinal worms (Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina ), and lungworms (Dictyocaulus filaria ).

(iii) Limitations. Do not slaughter for food within 72 hours of treatment. Conditions of constant helminth exposure may require retreatment 2 to 4 weeks after the first treatment. Consult veterinarian before using in severely debilitated animals.

(3) Swine - (i) Amount. 8 mg/kg body weight in drinking water.

(ii) Indications for use. Effective against the following nematode infections: Large roundworms (Ascaris suum ), nodular worms (Oesophagostomum spp.), intestinal thread worms (Strongyloides ransomi ) and lungworms (Metastrongylus spp. ).

(iii) Limitations. Do not administer within 72 hours of slaughter for food. Pigs maintained under conditions of constant exposure to worms may require retreatment within 4 to 5 weeks after the first treatment. Consult your veterinarian before administering to sick swine.

[69 FR 9753, Mar. 2, 2004, as amended at 69 FR 33839, June 17, 2004; 70 FR 2353, Jan. 13, 2005; 77 FR 28253, May 14, 2012; 78 FR 28822, May 20, 2014; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019]

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