We want to provide an important update regarding Food and Drug Administration's (FDA) Guidance for Industry (GFI) #256 and how it may impact compounded medication prescribing. Rood and Riddle Veterinary Pharmacy has dedicated significant resources to assist practitioners and clinics in navigating this landscape. We will be launching an improved digital platform, which includes a new website on May 27, 2026. We encourage you to use our new website, as it will guide you through the required steps and electronically capture all necessary additional information.

GFI #256 applies to compounding pharmacies preparing medications from Bulk Drug Substances (BDS) for:

• Patient-specific prescriptions for nonfood-producing animals
• Office stock medications for nonfood-producing animals. (Only in certain applicable states)

The primary focus of GFI #256 is compounded medications sold to veterinary practices as office-use medications. A secondary focus is on documentation requirements for patient-specific prescriptions when compounded medications are prescribed instead of commercially available FDA-approved products. Patient-specific dispensing has been our mainstay platform and the primary area covered by retail pharmacies. 

What This Means for Veterinarians/Veterinary Clinics

When prescribing a patient-specific compounded medication, if there is an FDA-approved product available with:

• the same active ingredient
• the same route of administration

...the FDA expects documentation of a medical rationale explaining why the compounded preparation will provide a clinical difference or medical benefit for the patient.

Our pharmacy staff will be requesting this information during the original order entry and will become part of the medical record. In addition, there is a new order form online with some of the listed medical rationales.

Examples of Acceptable Medical Rationales Include:

• The commercial product would reduce compliance or be ineffective in achieving the desired medical outcome.
• The commercial product is unavailable, backordered, or unable to be sourced.
• Commercial dosage forms are unsafe or impractical for the patient.
• The patient has intolerance, sensitivity, toxicity, or aversion to commercial products.
• The compounded preparation provides a clinically necessary strength, concentration, combination, dosage form, or route of administration not commercially available.

Common Examples of Acceptable Medical Rationales May Include:

• Multiple tablets or capsules required to achieve dose
• High administration volumes that are impractical
• Combination preparations to improve compliance
• Alternative dosage forms for patients unable to tolerate oral medications
• Allergies or sensitivities to excipients in commercial products

Office Stock Compounding (Applicable Only in Certain States)

Under GFI #256, office-stock compounded medications prepared from bulk drug substances must generally appear on the FDA’s:

• List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals, or
• Bulk Drug Substances Currently Under Review List

This circumstance is currently limited and is dependent on the allowance under state-specific regulations. Currently, several states are not aligned; for example, New York requires all prescriptions filled at a retail pharmacy to be patient-specific, so office use will not be an option. We are navigating each state individually.

At Rood and Riddle Veterinary Pharmacy, we are committed to helping veterinarians navigate these evolving requirements while continuing to provide high-quality compounded medications and regulatory support.

Our team will continue to work closely with prescribing veterinarians to make compliance as straightforward and efficient as possible.

If you have questions regarding GFI #256, medical rationale documentation, office stock eligibility, or specific compounded medications, please contact our pharmacy team at info@rrvp.com or (859) 246-0112.

Thank you for your continued partnership and dedication to patient care.