Answered by
Nick Tymochko, PharmD.,

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.

This is currently a gray area, as it’s still unclear whether it will be included or not in the guidance. Our 503B facility (Atlas Pharmaceuticals) does provide that extra level of quality and safety, as it manufactures compounds under strict, FDA-regulated cGMP standards—a quality standard also used in human drug manufacturing. And that’s what GFI #256 is really concerned about—how the products are being prepared. We’ve had and will continue to have conversations with the FDA, and as soon as we have clarity on this matter, we will share that information.

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.

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.

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.

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

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.

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.

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 Platform gives 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.