FDA's draft animal health GFI asserts that using bulk API in animal health compounds is illegal drug manufacturing  regardless of whether the compound is for an identified individual patient or for office use . The GFI spells out that FDA expects compounders to use a commercially available finished dosage form as the source of API  for all animal compounds .

 

Furthermore, the way the GFI defines a copy is restrictive in that if the substance has the same active ingredient and can be given by the same route of administration and is the same or substitutable strength, then it considered a copy and prohibited.  And there is a new requirement that the vet document the medical rationale for using the substance and the clinical difference from the FDA approved product.  

 

The GFI describes the circumstances under which the FDA will exercise enforcement discretion and not undertake enforcement action for the use of bulk API. It's here where we see the GFI specifying a different set of requirements for patient-specific animal compounds versus office-use compounds. For both, the GFI applies restrictions on the use of bulk API that are neither clear nor practical. Whether compounding patient-specific or office-use animal medications, the GFI places additional burdens on pharmacists and veterinarians that will decrease the quality of the finished compound, increase costs to prepare compounds, and ultimately limit patient access.