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

Guidance for Industry #256 describes the FDA’s approach to enforcement discretion for compounded drugs from bulk substances and applies to any company compounding 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. The Guidance may encourage practices to prescribe patient-specific compounded medication, including a medical rationale for prescribing, rather than distributing compounds from office stock.

• Office stock compounded drugs for emergency use, without a patient specific prescription, will need to be compounded from the FDA’s “positive list”. List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals.
• Compounded drugs made from active pharmaceutical ingredients (APIs) that are NOT on the FDA “positive list” will need to be tied to a patient-specific prescription.
• When prescribing patient-specific compounds, 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, it will be up to the pharmacy to obtain the rationale for the compounded product.

Medical justifications include, but are not limited to:

• Compounded product increases compliance
• Compounded product offers strength not commercially available
• Compounded product offers flexibility in dosing
• Compounded product avoids ingredients harmful to the patient
• FDA-approved product unavailable

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. Medical rationale for prescribing can be easily entered in the “Notes to Pharmacy” section when writing each script.

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

It actually applies to both scenarios. 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 scripts, stating why you are prescribing a compounded product instead of a commercially available product.

Medications obtained from pharmacies before the April 1st enforcement date can still be kept by the practice and administered to the clients dependent on your state’s regulations. There is no need to send the product back to the pharmacy or destroy, quarantine, or dispose of these products after the deadline for enforcement begins.

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 approved justifications that the FDA gives as examples 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 states that documentation is needed on the prescription from either the veterinarian or the pharmacy dispensing the product. Adding the medical rationale to the “Notes to Pharmacy” section 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 our patients’ profile for refills and future fills of that medication.

We are still working through those. When we started the nomination process, the FDA wanted to evaluate each individual ingredient, and we understood that at Covetrus. The antibiotics that are put in otic preparations have already been submitted individually to the FDA. So, only individual ingredients were submitted originally, no combinations. That will be open to discussion with the FDA.

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 in regard to rules on markup or pricing.

A prescription can be written for one individual patient or a group of patients 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 solutions give you the ability to manage prescriptions efficiently, while delivering a convenient online shopping experience your clients will love. Easily create, approve, and renew scripts 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 facilities
  Our facilities are continuously monitored 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 are proud to adhere to the highest compounding standards in the nation, delivering quality you can count on.
• 503B outsourcing facility (Atlas Pharmaceuticals) for office-use compounds
  Covetrus compounds are manufactured under strict FDA regulated cGMP standards, delivering quality you can rely on for your office-use medications. Our pharmacies are backed by a team of quality experts ready to fulfill all of your compounding needs at compounds.covetrus.com.