(e) The veterinarians specified
withdrawal, withholding, or discard time for meat, milk, eggs, or any
other food which might be derived from the treated animal or 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:
(c) Guidance on the subject of
compounding may be found in guidance documents issued by FDA.
- All relevant portions of this part have been complied with;
- 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;
- The compounding is performed by a licensed pharmacist or veterinarian
within the scope of a professional practice;
- Adequate procedures and processes are followed that ensure the safety
and effectiveness of the compounded product;
- The scale of the compounding operation is commensurate with the
established need for compounded products (e.g., similar to that of
comparable practices); and
- All relevant State laws relating to the compounding of drugs for
use in animals are followed.