[Title 21 CFR 522.740]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)]
[Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS]
[Part 522 - IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS]
[Sec. 522.740 - Disophenol sodium injection.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  6
  1996-04-01
  1996-04-01
  false
  
  522.740
  Sec. 522.740
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
    ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
    IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
  


Sec. 522.740   Disophenol sodium injection.

    (a) Chemical name. Sodium 2,6-diiodo-4-nitrophenoxide.
    (b) Specifications. The drug is sterile and contains the equivalent 
of 0.9 or 4.5 percent disophenol in polyethylene glycol 400 and 
distilled water.
    (c) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
    (d) Conditions of use. (1) The drug is used for the treatment of 
both dogs infested with hookworms (including Ancylostoma caninum, A. 
braziliense and Uncinaria stenocephala) and cats infested with the 
hookworm A. tubaeforme.
    (2) It is administered subcutaneously at a dosage level equivalent 
to 4.5 milligrams of disophenol per pound of body weight. A second 
treatment may be indicated 21 days after the initial treatment.
    (3) Do not repeat treatment in less than 21 days.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (5) Use for the treatment of dogs infested with hookworms (including 
Ancylostoma canium, A. braziliense and Uncinaria stenocephala) is NAS/
NRC reviewed and deemed effective. Applications for these uses need not 
include ef

[[Page 259]]

fectiveness data as specified by Sec. 514.111 of this chapter, but may 
require bioequivalency and safety information.

[40 FR 13858, Mar. 27, 1975, as amended at 41 FR 43400, Oct. 1, 1976; 42 
FR 41855, Aug. 19, 1977; 45 FR 43402, June 27, 1980; 47 FR 14150, Apr. 
2, 1982]