Code of Federal Regulations Title 21. Food and Drugs § 21.530.13 Extralabel use from compounding of approved new animal and approved human drugs

(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 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.