21 C.F.R. § 558.485

Current through October 31, 2024
Section 558.485 - Pyrantel
(a)Specifications. Type A medicated articles containing 48 or 80 grams per pound pyrantel tartrate.
(b)Sponsors. See sponsors in § 510.600(c) of this chapter for use as follows:
(1) No. 066104: 48 and 80 grams per pound for use as in paragraph (e)(1) of this section.
(2) Nos. 017135 and 054771: 48 grams per pound for use as in paragraph (e)(2) of this section.
(c)Related tolerances. See § 556.560 of this chapter.
(d)Special considerations.
(1) See § 500.25 of this chapter. Consult a veterinarian before using in severely debilitated animals.
(2) Do not mix in Type B or Type C medicated feeds containing bentonite.
(e)Conditions of use -
(1)Swine -

Pyrantel
grams/ton
Indications for useLimitationsSponsor
(i) 96Swine: As an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infectionsFeed continuously as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter066104
(ii) 96Swine: For the removal and control of large roundworm (Ascaris suum) infectionsFeed for 3 days as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter066104
(iii) 800Swine: For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum) infectionsFeed as the sole ration for a single therapeutic treatment in Type C feed at a rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb, and 5 lb of feed per head for animals 200 lb or over. Withdraw 24 hours prior to slaughter066104

(2)Horses -

Pyrantel tartrate
g/ton
Indications for useLimitationSponsor
(i) 120 to 1,200 to provide 1.2 mg/lb body weightFor prevention of Strongylus vulgaris larval infections; control of adult large strongyles (S. vulgaris, and S. edentatus), adult and 4th stage larvae small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage larvae pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids (Parascaris equorum)Feed continuously as the horse's daily grain ration during the time that the animal is at risk of exposure to internal parasites. Do not use in horses intended for human consumption. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism017135
054771

(ii)Top dress medicated feed -
(A)Proprietary Formulas. The following feed can be manufactured only per an approved proprietary formula and specifications:

Pyrantel tartrate amountIndications for useLimitationsSponsor
(1) 9.6 g/lb to provide 1.2 mg/lb body weightPrevention of Strongylus vulgaris larval infections; control of adult large strongyles (S. vulgaris, and S. edentatus), adult and 4th stage larvae small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage larvae pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids (Parascaris equorum)Feed continuously as a top dress during the time that the animal is at risk of exposure to internal parasites. Do not use in horses intended for human consumption. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism017135
054771
(2) [Reserved].

(B) [Reserved]
(3) Pyrantel may also be used in combination with:
(i) Carbadox as in § 558.115 .
(ii) Lincomycin as in § 558.325 .
(iii) Tylosin as in § 558.625 .

21 C.F.R. §558.485

83 FR 48948 , Sept. 28, 2018, as amended at 83 FR 64744 , Dec. 18, 2018; 86 FR 14826 , Mar. 19, 2021; 89 FR 42360 , May 15, 2024
81 FR 95013, 12/27/2016; 82 FR 21692, 5/10/2017; 83 FR 48948, 10/9/2018; as amended at 83 FR 64744, 12/18/2018; 86 FR 14826, 3/19/2021; 89 FR 42360, 5/15/2024