TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS

520.2520g - Trichlorfon, phenothiazine, and piperazine dihydrochloride powder.

  (a) Specifications. Each 54.10 grams (1.91 ounces) of water dispersible powder contains 9.10 grams of trichlorfon, 6.25 grams of phenothiazine, and the equivalent of 20.0 grams of piperazine base (as piperazine dihydrochloride).

  (b) Sponsor. See No. 000856 in 510.600(c) of this chapter.

  (c) Special considerations. Labeling shall bear the following statements: The drug is a cholinesterase inhibitor. Do not use this product in horses simultaneously with, or within 2 weeks before or after treatment with, or exposure to, neuromuscular depolarizing agents (e.g., succinylcholine) or to cholinesterase-inhibiting drugs, pesticides, or chemicals.

  (d) Conditions of use(1) Amount. 18.2 milligrams of trichlorfon, 12.5 milligrams of phenothiazine, and 40.0 milligrams of piperazine base per pound of body weight.

  (2) Indications for use. For horses for removal of bots (Gastrophilus nasalis, Gastrophilus intestinalis), large strongyles (Strongylus vulgaris), small strongyles, large roundworms (ascarids, Parascaris equorum), and pinworms (Oxyuris equi).

  (3) Limitations. Mix powder and vial contents together in warm water to form suspension. Administer by stomach tube. Do not fast horses before or after treatment. Treatment of mares in late pregnancy is not recommended. Surgery or any severe stress should be avoided for at least 2 weeks before or after treatment. Do not administer to sick, toxic, or debilitated horses. Not to be used in horses intended for use as food.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 2757, Jan. 21, 1983]