GFI 256: What You Need to Know
GFI #256: FDA Guidelines for Compounding Animal Medications
As of April 1, 2023, the FDA Guidelines for GFI #256 have officially been implemented. GFI #256, “Compounding Animal Drugs from Bulk Drug Substances” is a new FDA guidance that highlights the FDA’s views on compounding animal drugs prepared with bulk drug substances.
There are three major guidelines surrounding GFI 256:
The first is that the FDA has established lists defining which preparations compounded using Bulk Drug Substances (BDS) will be available for veterinary office use. Medications on the FDA’s list of office stock drugs and medications under review may be ordered for office use or prescriptions. Medications that have been reviewed and not listed may be prescribed for patients but are not available for office use.
Next, for medications compounded from our USP bulk powders for individual patients, it may require the veterinarian to supply a clinical reason as to why the medication needs to be compounded instead of using an FDA-approved medication. Examples include: Allergies to fillers, food sensitivity, etc. to commercial products; the commercially available dosage form is unsafe for patient usage; approval product only available to veterinarians; ingredients add too much bulk; etc…
Lastly, reporting Adverse Effects, Incidents, and product defects will be required using Form 1932A.
For veterinarians, we do have an order form that can be filled out to order medications for your clients with the listed approved reasoning for why the medication needs to be compounded. Please contact us with any questions or concerns. We are here to help your veterinary office and your patients.