[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: 21CFR530.13]

[Page 333-334]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 530--EXTRALABEL DRUG USE IN ANIMALS--Table of Contents
 
 Subpart B--Rules and Provisions for Extralabel Uses of Drugs in Animals
 
Sec.  530.13  Extralabel use from compounding of approved new animal and approved human drugs.

    (a) This part applies to compounding of a product from approved 
animal or human drugs by a veterinarian or a pharmacist on the order of 
a veterinarian within the practice of veterinary medicine. Nothing in 
this part shall be construed as permitting compounding from bulk drugs.
    (b) Extralabel use from compounding of approved new animal or human 
drugs is permitted if:
    (1) All relevant portions of this part have been complied with;
    (2) There is no approved new animal or approved new human drug that, 
when used as labeled or in conformity with criteria established in this 
part, will, in the available dosage form and concentration, 
appropriately treat the condition diagnosed. Compounding from a human 
drug for use in food-producing animals will not be permitted if

[[Page 334]]

an approved animal drug can be used for the compounding;
    (3) The compounding is performed by a licensed pharmacist or 
veterinarian within the scope of a professional practice;
    (4) Adequate procedures and processes are followed that ensure the 
safety and effectiveness of the compounded product;
    (5) The scale of the compounding operation is commensurate with the 
established need for compounded products (e.g., similar to that of 
comparable practices); and
    (6) All relevant State laws relating to the compounding of drugs for 
use in animals are followed.
    (c) Guidance on the subject of compounding may be found in guidance 
documents issued by FDA.