FDA Guidance for Industry (GFI) #256 is now in effect

Guidance for Industry #256 describes the FDA’s enforcement policy regarding drugs compounded from bulk drug substances for patient-specific prescriptions for nonfood-producing animals and office stock for nonfood-producing animals. This Guidance may help veterinarians in providing appropriate care for the medical needs of their patients when no FDA approved drug can be used.

GFI #256 limits the compounded products available for office stock. This Guidance may encourage practices to prescribe patient-specific compounded medication, including a medical rationale for prescribing, rather than distributing, compounded medication from office stock.

When prescribing a patient-specific compounded medication, if there is an FDA approved product available with the same active ingredient, with the same route of administration, then you should document a medical rationale in your records noting why the compounded product will make a clinical difference for the patient. You will then need to provide this rationale to the compounding pharmacist upon ordering. If the veterinarian does not provide medical rationale on the prescription, the pharmacy will need to contact you to obtain the rationale for the compounded product.

There are 5 examples of medical justifications that the FDA provides in the guidance document on pages 10 –11. 

To adapt to these workflow changes more easily, you can sign up for our patient-specific ordering platform to ensure continuity of care for patients and to make patient-specific ordering easier. Personalized, pet-friendly dose forms can be ordered and sent from your prescription management platform directly to your patients, making it convenient for your staff and for pet owners. To ensure compliance with GFI #256, medical rationale may be required when prescribing a compounded product. For products requiring medical rationale, there is a “reason for prescribing compounding” dropdown in vRxPro® with a list of justification reasons from which to choose.. 

Please reach out to your local Covetrus representative or call our pharmacy at (877) 518-4589 to learn more.

Yes. The FDA has approved some compounded medications to be ordered for office stock. However, these active pharmaceutical ingredients (API) are in very specific dose forms and strengths and even specify for what species these medications can be kept in-clinic. 

If a different strength is needed than what is on the approved list, it will need to be prescribed for an individual patient instead of ordering it as office stock for the practice. 

It applies to both. GFI #256 is concerned about how the compounded product is being prepared, whether the source of the ingredients is from an FDA approved, conditionally approved, or indexed drug, or if that starting source is from bulk drug substances. The primary focus of GFI #256 is products that are being sold to the practice as office–use medications. A secondary focus is the need for documentation on patient-specific prescriptions, stating why you are prescribing a compounded product instead of a commercially available product. 

GFI #256’s applicability is not expressly answered in the guidance document. What GFI #256 is really concerned about is how the products are being prepared. Nevertheless, you can still contract with 503Bs for compounded products for office stock in a manner approved by the FDA and state law. 

GFI #256 applies to any compounding pharmacy compounding from bulk drug substances for patient-specific prescriptions for nonfood-producing animals and office stock for nonfood-producing animals. 

The main difference is that additional documentation for prescribing a compounded medication will be needed—a justification as to why you are choosing a strength or dosage form that differs from the commercially available product. There are 5 examples of medical justifications that the FDA provides in the guidance document on pages 10–11. This documentation is necessary so that if the FDA audits the pharmacy, we can explain why the veterinarian chose this preparation instead of the commercially available product. 

Yes, GFI #256 states that the pharmacist should maintain a record of the medical rationale from the veterinarian describing the clinical difference between the compounded drug and the FDA-approved or indexed drug. Adding the medical rationale via the “reason for prescribing compound” dropdown” in vRxPro will capture the documentation piece that is being requested and will fulfill the documentation requirements. This only needs to be done once per prescription for a client, as we will capture the documentation and add it to the patient’s profile for refills of that medication. 

The most common otic combinations were nominated for inclusion on the FDA Guidance “List of Bulk Drug Substances for Compounding Office Use Stock Drugs for Use in Nonfood-Producing Animals.” Many of the otic combinations nominated are still on the “Bulk Drug Substances Currently Under Review” list and therefore can continue to be ordered for office use. We monitor the GFI #256 lists daily for bulk drug substances that are either approved or denied for office use, and will update our offerings accordingly.

We can ship prescriptions directly to the client or to the practice. The only exception is we cannot ship prescriptions for controlled substances to the practice, as the DEA states that the end user has to receive that product directly. We recommend that you check with your state veterinary board regarding rules on markup or pricing.

A prescription can be written for one individual patient or a group of patients in a specific, identified location being treated for the same condition by the veterinarian. For shelters and rescues, products could be written as a prescription with additional documentation about the species, number of animals being medicated, and the condition for which the medication is prescribed. We encourage you to confirm this information with your local VMA. 

The Covetrus prescription management platform, vRxPro, gives you the ability to manage prescriptions efficiently, while delivering a convenient online shopping experience your clients will love. Easily create, approve, and renew prescriptions  for diets, preventatives, compounded medications, and more. When prescribing compounded medications, you can view the different strengths, dose forms, and flavors available to personalize the medication for your specific patient. Learn more about Covetrus® Compounding and Covetrus® vRxPro® software. 

• A dedicated team of 300+ pharmacy staff members
  Our pharmacists are trained to ensure veterinarians receive quality medications to deliver top-notch care in accordance with the new guidelines.
• Continuously monitored pharmacies
  We continuously monitor and improve our pharmacies to ensure the highest quality product possible is delivered to you and your patients in the right form, at the right time.
• USP-compliant and PCAB accredited 503A pharmacies
  Our pharmacies meet rigorous requirements for the preparation of compounded medications, delivering quality you can count on.