21 C.F.R. § 558.485

Current through November 30, 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 use	Limitations	Sponsor
(i) 96	Swine: 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) infections	Feed continuously as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter	066104
(ii) 96	Swine: For the removal and control of large roundworm (Ascaris suum) infections	Feed for 3 days as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter	066104
(iii) 800	Swine: For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum) infections	Feed 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 slaughter	066104

(2)Horses -

Pyrantel tartrate g/ton	Indications for use	Limitation	Sponsor
(i) 120 to 1,200 to provide 1.2 mg/lb body weight	For 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 parasitism	017135 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 amount	Indications for use	Limitations	Sponsor
(1) 9.6 g/lb to provide 1.2 mg/lb body weight	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 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 parasitism	017135 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