[Title 21 CFR 522.204]
[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. 522.204 - Boldenone undecylenate injection.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  6
  1996-04-01
  1996-04-01
  false
  
  522.204
  Sec. 522.204
  
    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. 522.204   Boldenone undecylenate injection.

    (a) Specifications. Each milliliter contains 25 or 50 milligrams of 
boldenone undecylenate in a sesame oil base.
    (b) Sponsor. See No. 053501 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is intended for use as an aid in 
treating debilitated horses following disease or overwork and 
overexertion when an improvement in weight, hair coat, or general 
physical condition is desired. The drug is given only as adjunctive 
therapy to other specific and supportive therapy for diseases, surgical 
cases, and traumatic injuries. Optimal results can be expected only when 
good management and feeding practices are followed.
    (2) It is administered intramuscularly at a dosage level of 0.5 
milligram per pound of body weight. Treatment may be repeated at 3-week 
intervals.
    (3) For use in horses only. Do not administer to horses intended for 
use as food. The effectiveness of the drug in stallions and pregnant 
mares has not been established, nor has the drug been shown not to be 
teratogenic in pregnant mares; therefore, this drug should not be used 
in stallions and pregnant mares.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 41489, Oct. 11, 1985]