[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.480]

[Page 228]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  522.480  Repository corticotropin injection.

    (a)(1) Specifications. The drug conforms to repository corticotropin 
injection U.S.P. It contains 40 or 80 U.S.C. (I.U.) units per cubic 
centimeter.
    (2) Sponsor. See No. 037990 in Sec.  510.600(c) of this chapter.
    (3) Special considerations. The drug should be refrigerated. With 
prolonged use supplement daily diet with potassium chloride at one gram 
for small animals and from 5 to 10 grams for large animals.
    (4) Conditions of use. (i) It is used as an intramuscular or 
subcutaneous injection in cattle and small animals for stimulation of 
the adrenal cortex where there is a general deficiency of corticotropin 
(ACTH). It is also a therapeutic agent for primary bovine ketosis.
    (ii) It is administered to cattle initially at 200 to 600 units 
followed by a dose daily or every other day of 200 to 300 units and to 
small animals at one unit per pound of body weight to be repeated as 
indicated.
    (iii) For use only by or on the order of a licensed veterinarian.
    (b)(1) Specifications. The drug conforms to respository 
corticotropin injection U.S.P. It contains 40 or 80 U.S.P. units per 
milliliter.
    (2) Sponsor. See No. 000864 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use. (i) For intramuscular injection in dogs as a 
diagnostic aid to test for adrenal dysfunction. For intramuscular or 
subcutaneous injection in dogs and cats for stimulation of the adrenal 
cortex where there is a general deficiency of ACTH.
    (ii) For diagnostic use: Administer at one unit per pound of body 
weight intramuscularly. For therapeutic use: Administer at one unit per 
pound of body weight intramuscularly or subcutaneously, initially, to be 
repeated as indicated.
    (iii) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.
    (c) National Academy of Sciences/National Reserach Council (NAS/NRC) 
status. The therapeutic indication for use has been reviewed by NAS/NRC 
and found to be effective. Applications for this use need not include 
effectiveness data as specified in Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.

[40 FR 13858, Mar. 27, 1985, as amended at 50 FR 40966, Oct. 8, 1985; 53 
FR 45760, Nov. 14, 1988]