[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.45a]

[Page 96-97]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 520.45a  Albendazole suspension.

    (a)(1) Specifications. The product contains 11.36 percent 
albendazole.
    (2) Sponsor. See No. 000069 in Sec. 510.600 of this chapter.
    (3) Related tolerances. See Sec. 556.34 of this chapter.
    (4) Conditions of use in cattle--(i) Amount. 4.54 milligrams per 
pound of body weight (10 milligrams per kilogram).
    (ii) Indications for use. For removal and control of the following 
internal parasites of cattle: Adult liver flukes (Fasciola hepatica); 
heads and segments of tapeworms (Moniezia benedeni, M. expansa); adult 
and 4th stage larvae of stomach worms (brown stomach worms including 4th 
stage inhibited larvae (Ostertagia ostertagi), barberpole worm 
(Haemonchus contortus, H. placei), small stomach worm (Trichostrongylus 
axei)); adult and 4th stage larvae of intestinal worms (thread-necked 
intestinal worm (Nematodirus spathiger, N. helvetianus), small 
intestinal worm (Cooperia punctata and C. oncophora)); adult stages of 
intestinal worms (hookworm (Bunostomum phlebotomum), bankrupt worm 
(Trichostrongylus colubriformis), nodular worm (Oesophagostomum 
radiatum)); adult and 4th stage larvae of lungworms (Dictyocaulus 
viviparus).
    (iii) Limitations. Administer as a single oral dose using dosing gun 
or dosing syringe. Do not slaughter within 27 days of last treatment. Do 
not use in female dairy cattle of breeding age: Do not administer to 
female cattle during first 45 days of pregnancy or for 45 days after 
removal of bulls. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.
    (b)(1) Specifications. The product contains 4.55 or 11.36 percent 
albendazole.
    (2) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (3) Related tolerances. See Sec. 556.34 of this chapter.
    (4) Conditions of use in sheep--(i) Amount. 7.5 milligrams per 
kilogram of body weight (3.4 milligrams per pound).

[[Page 97]]

    (ii) Indications for use. For removal and control of the following 
internal parasites of sheep: Adult liver flukes (Fasciola hepatica, 
Fascioloides magna); heads and segments of common tapeworms (Moniezia 
expansa) and fringed tapeworm (Thysanosoma actinioides); adult and 
fourth stage larvae of stomach worms (brown stomach worm (Ostertagia 
circumcinta and Marshallagia marshalli), barberpole worm (Haemonchus 
contortus), small stomach worm (Trichostrongylus axei)); adult and 
fourth stage larvae of intestinal worms (thread-necked intestinal worm 
(Nematodirus spathiger and N. filicollis), Cooper's worm (Cooperia 
oncophora), bankrupt worm (Trichostrongylus colubriformis), nodular worm 
(Oesophagostomum columbianum), and large-mouth bowel worm (Chabertia 
ovina)); adult and larval stages of lungworms (Dictyocaulus filaria).
    (iii) Limitations. Administer as a single oral dose using dosing gun 
or dosing syringe. Do not slaughter within 7 days of last treatment. Do 
not administer to ewes during first 30 days of pregnancy or for 30 days 
after removal of rams. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.

[54 FR 25115, June 13, 1989, as amended at 56 FR 50653, Oct. 8, 1991; 59 
FR 65711, Dec. 21, 1994; 60 FR 55658, Nov. 2, 1995; 61 FR 4875, Feb. 9, 
1996; 64 FR 1504, Jan. 11, 1999]