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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: 21CFR520.2043]



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. 520.2043 Pyrantel pamoate suspension.

(a) Specifications. (1) Each milliliter (mL) contains pyrantel pamoate equivalent to 50 milligrams (mg) pyrantel base.

(2) Each mL contains pyrantel pamoate equivalent to 2.27 or 4.54 mg pyrantel base.

(3) Each mL contains pyrantel pamoate equivalent to 4.54 mg pyrantel base.

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

(1) Nos. 054771, 058829, and 069043 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section.

(2) Nos. 054771, 058198, and 058829 for use of the products described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.

(3) No. 023851 for use of the product described in paragraph (a)(3) as in paragraph (d)(2) of this section.

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

(d) Conditions of use - (1) Horses and ponies. It is used as follows:

(i) Amount. 3 mg per pound (/lb) body weight as a single dose mixed with the usual grain ration, or by stomach tube or dose syringe.

(ii) Indications for use. For the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus ); pinworms (Oxyuris equi ); large roundworms (Parascaris equorum ); and small strongyles.

(iii) Limitations. Do not use in horses intended for human consumption. When the drug is for administration by stomach tube, it shall be labeled: "Federal law restricts this drug to use by or on the order of a licensed veterinarian."

(2) Dogs. It is used as follows:

(i) Dogs and puppies - (A) Amount. 2.27 mg/lb body weight as a single dose in the animal's feed bowl by itself or mixed in a small quantity of food.

(B) Indications for use. For the removal of large roundworms (Toxocara canis and Toxascaris leonina ) and hookworms (Ancylostoma caninum and Uncinaria stenocephala ).

(C) Limitations. Additional treatment may be required and should be confirmed by fecal examination within 2 to 4 weeks.

(ii) Dogs, puppies, and lactating bitches after whelping - (A) Amount. 2.27 mg/lb body weight.

(B) Indications for use. To prevent reinfections of T. canis.

(C) Limitations. Administer to puppies at 2, 3, 4, 6, 8, and 10 weeks of age. Administer to lactating bitches 2 to 3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals.

[67 FR 43248, June 27, 2002, as amended at 68 FR 54803, Sept. 19, 2003; 68 FR 55199, Sept. 23, 2003; 68 FR 55825, Sept. 29, 2003; 75 FR 52622, Aug. 27, 2010; 76 FR 17337, Mar. 29, 2011; 78 FR 17596, Mar. 22, 2013; 79 FR 28827, May 20, 2014; 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, 2016; 86 FR 14819, Mar. 19, 2021]

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