Compounding from FDA-approved drugs is considered extralabel drug use under FDA rules.
Compounding is the customized manipulation of an approved drug(s) by either a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient. For example, splitting a pill into multiple pieces is considered compounding as it’s being altered from its original state.
Compounding is not allowed unless there is no approved new animal or approved new human drug that, when used per label or in an extra label fashion, can appropriately treat the condition diagnosed. In this case, the medication must be prepared by an approved compounding pharmacy.
When is compounding necessary?
Compounding may be necessary when approved drugs need to be modified to sufficiently treat the patient (e.g., through flavoring, diluting, or changing the form of medications from tablet to suspension)
Compounding might also be necessary when no approved drug exists, or if the approved drug isn’t commercially available to treat a pet’s diagnosed condition.
If your pet has a prescription pill that you need help splitting into two doses, please request a pill splitter from a Patient Care Coordinator for a nominal fee.