FDA GFI #256: Compounding Animal Drugs from Bulk Drug Substances

Compounding guidance is tightening up.

Even though the FDA will not come into veterinary hospitals, ordering compounded substances may become more challenging. How will this affect your patients and their prescriptions?

When does GFI #256 apply?

This guidance applies when ordering compounded animal drugs made from bulk substances for office stock. Additionally, it applies to prescriptions for food-producing species and free-range wildlife, regardless of whether your request is for a patient-specific prescription or office stock.

What can be ordered for office stock:

Medications ordered for office stock must be listed on the relevant FDA List of Bulk Drug Substances for Compounding:

Additional documentation requirements:

Requests for patient-specific compounded products must include your medical rationale.

Examples of acceptable medical rationale:

  • Compliance is reduced with the commercial product in this patient and is not effective for achieving the desired medical outcome.
  • The commercially approved product is not available
  • Using the commercially available dosage form is not safe for the patient
  • Patient (or population) has sensitivity, toxicity or aversion to the commercial product
  • Patient cannot be safely medicated/pilled with the approved product

Food-producing species and free-range wildlife:

Regardless of whether your request is for a patient-specific prescription or office stock, the compounded medication must be on the FDA List of Bulk Drug Substances (BDS) for Compounding Drugs for Food-Producing Animals or Free-Ranging Wildlife Species.

We can’t control changes to FDA guidelines, but we can control how informed you are.

Key takeaway: Now is the time to contact the compounding pharmacies you frequently use. Find out how this will affect the compounded preparations you typically prescribe for your patients or purchase for office stock.

Keep your clients informed, and your staff stress-free.

Skip the stress and confusion by informing your team about this change to ordering compounded meds. Download and/or print the materials below to disseminate amongst your staff digitally or hang up in common areas in the clinic.

Huge thank you to Dr. Heather Lindell Tally for reviewing/editing our quick reference guides for accuracy.

We all know that one client who always waits until the last second to refill their pets meds.

We recommend informing your clients of this change in general, but most importantly, it is important that your clients who own pets currently prescribed compounded preparations are aware as soon as possible. With the additional verification requirements, the process to refill compounded medications may take a little longer.

  1. Pull a report of all patients currently prescribed any compounded medication that may be affected by GFI #256.
  2. Draft an email and send to the clients that are on the report you just pulled.
  3. Inform these clients to do their best to refill their pet’s compounded medication well before they are going to run out. Requesting the refill a few extra days in advance gives veterinary teams and pharmacists time to get used to the new verification process.

Simply copy and paste the below email template to send out to all clients with pets that may be affected:


SUBJECT: Your Pet’s Prescription: Important FDA Changes



The FDA oversees prescription medications, including those that are FDA-approved and patient-specific compounded medications. [PET NAME] is on a compounded medication and a new FDA guideline requires that we provide a little more information about why [PET NAME] needs this product rather than the FDA-approved product.  When you need to refill [PET NAME]’s prescription – the pharmacy may reach out to us with some questions and we will be happy to assist them.  We do not anticipate any problems, but please order the refill in a timely manner, before you are running low on supply, just in case there are unexpected delays in processing [PET’S NAME]’s refill.

If you have any questions please contact us at [CLINIC PHONE] or send an email to [CLINIC EMAIL].

Thank you for trusting us in your care of [PET’S NAME],



Still have questions?

Submit comments on this guidance at any time:

Click here to submit electronic comments.

Submit written comments to:

Dockets Management Staff (HFA- 305), Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the docket number FDA-2018-D-4533.

For further information regarding this document, contact AskCVM@fda.hhs.gov.