21 C.F.R. § 558.315 Levamisole hydrochloride (equivalent).
Title 21 - Food and Drugs
(a) Approvals. Type A medicated articles: 227 grams per pound to No. 053501 in §510.600(c) of this chapter. (b) Related tolerances. See §556.350 of this chapter. (c) Conditions of use. It is used in Type C medicated feed as follows: (1) Cattle—(i) Amount per pound. 0.36–3.6 grams (0.08–0.8 percent). (ii) Indications for use. Treatment of the following gastrointestinal worms and lung worm infections; stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms (Dictyocaulus). (iii) Limitations. Administer medicated feed mixed thoroughly in one half the usual amount of morning feed; the medicated feed mix should be consumed within 6 hours; when medicated feed is consumed resume normal feeding; medicated feed is to be fed at the rate of 0.36 gram of levamisole hydrochloride (equivalent) per 100 lb. of body weight; conditions of constant helminth exposure may require retreatment within 2 to 4 weeks after the first treatment; do not slaughter for food within 48 hours of treatment; consult veterinarian before using in severely debilitated animals; do not administer to dairy animals of breeding age; for use in pelleted or meal feeds only; the label shall bear the caution, “Muzzle foam may be observed. However, this reaction will disappear within a few hours. If this condition persists, a veterinarian should be consulted. Follow recommended dosage carefully.” (2) Swine—(i) Amount per pound. 0.36 grams (0.08 percent). (ii) Indications for use. Treatment of the following nematode infections: large roundworms (Ascaris suum), nodular worms (Oesophagostomum spp.), lungworms (Metastrongylus spp.), intestinal threadworms (Strongyloides ransomi), swine kidney worms $(Stephanurus dentatus). (iii) Limitations. It is recommended that regular feed be withheld overnight and worming feed administered the following morning; dilute supplement with nonmedicated feed as directed; feed the equivalent of 1 lb. of 0.08 percent worming feed per 100 lbs. of body weight of pigs to be treated; may be fed as sole feed or thoroughly mixed with 1 to 2 parts of regular feed prior to feeding; when medicated feed is consumed, resume normal feeding. Pigs maintained under conditions of constant worm exposure may require retreatment within 4 to 5 weeks after the first treatment due to reinfection; do not slaughter for food within 72 hours of treatment; the label shall bear the caution, “Excessive salivation or muzzle foam may be observed. This reaction is occasionally seen and will disappear in a short time after medication. If pigs are infected with mature lungworms, coughing and vomiting may be observed soon after medicated feed is consumed. This reaction is due to the expulsion of worms from the lungs and will be over in several hours.” [40 FR 13959, Mar. 27, 1975, as amended at 43 FR 11176, Mar. 17, 1978; 43 FR 39351, Sept. 5, 1978; 43 FR 16013, Mar. 16, 1979; 51 FR 7398, Mar. 3, 1986; 67 FR 63055, Oct. 10, 2002]
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.315 Levamisole hydrochloride (equivalent).
