[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.315]

[Page 422-423]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents
 
      Subpart B--Specific New Animal Drugs for Use in Animal Feeds
 
Sec.  558.315  Levamisole hydrochloride (equivalent).

    (a) Approvals. Type A medicated articles: 227 grams per pound to No. 
053501 in Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  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

[[Page 423]]

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]