February 2, 2024

FDA adds Q&A on medical rationales for animal drug compounding

FDA has added a new section to its Q&A webpage for GFI #256 – Compounding Animal Drugs from Bulk Drug Substances. Here are the high points:

  • The medical rationale has to originate from the veterinarian, not the pharmacy. 
  • A drop-down menu with prefilled medical rationales of the five reasons listed in GFI #256 is not considered sufficient documentation—more specificity for that particular patient must be included (e.g., the specific ingredient to which the patient is allergic). 
  • If an FDA-approved drug product comes in multiple dosage forms with the same route of administration, a separate medical rationale is needed for each dosage form (e.g., “patient cannot be safely pilled” covers the capsule form but not necessarily chewable tablets or oral solutions). 
  • Pharmacies can generally rely on the medical rationale from the original prescription for refills, but should consider if the rationale remains applicable and contains adequate detail (e.g., if a new FDA-approved drug is available, consider whether the new drug negates the medical rationale provided).  
  • A patient-specific rationale can be applied to all applicable animals in the same identified location only if they share the characteristic that makes the FDA-approved drug unsuitable (e.g., an FDA-approved product containing xylitol could be applied as a medical rationale to all dogs in the same group, but patient-specific flavor preferences cannot).