CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.260]

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

Sec. 520.260 n-Butyl chloride.

(a) Specifications. Each capsule contains 221, 442, 884, or 1,768 milligrams (mg); or 4.42 grams of n -butyl chloride.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter:

(1) No. 023851 for capsules containing 221, 442, 884, or 1,768 mg, or 4.42 grams (g); and

(2) No. 054771 for capsules containing 221 mg.

(c) Conditions of use in dogs - (1) Amount. Administer capsules orally based on body weight as follows:

(i) Capsules containing 221 mg: Under 5 pounds, 1 capsule per 1 1/4 pounds of body weight.

(ii) Capsules containing 442 mg: Under 5 pounds, 1 capsule per 2 1/2 pounds of body weight.

(iii) Capsules containing 884 mg:

(A) Under 5 pounds, 1 capsule;

(B) 5 to 10 pounds, 2 capsules;

(C) 10 to 20 pounds, 3 capsules;

(D) 20 to 40 pounds, 4 capsules;

(E) Over 40 pounds, 5 capsules.

(iv) Capsules containing 1,768 mg: Dogs weighing 5 to 10 pounds, 1 capsule.

(v) Capsules containing 4.42 g: Dogs weighing 40 pounds or over, 1 capsule.

(2) Indications for use. For the removal of ascarids (Toxocara canis and Toxascaris leonina ) and hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala ) from dogs.

(3) Limitations. Dogs should not be fed for 18 to 24 hours before being given the drug. Administration of the drug should be followed in 1/2 to 1 hour with a mild cathartic. Normal feeding may be resumed 4 to 8 hours after treatment. Animals subject to reinfection may be retreated in 2 weeks. A veterinarian should be consulted before using in severely debilitated dogs.

[86 FR 10819, Feb. 23, 2021]