GFI #256: It's Here. Now What?
Last Update: May 9, 2023 | Check back frequently for updates.
The FDA has implemented new guidance that impacts the availability of some compounded medications for office use. Our full formulary remains available. We’re here to make compliance simple.
We make compliance simple.
FDA's GFI #256, Compounding Animal Drugs from Bulk Drug Substances, is now in effect. Wedgewood Pharmacy has made the change as seamless as possible for veterinarians.
Two updates to our digital ordering tool:
- Rationales - When writing a prescription, we'll provide a list of medical rationales to choose from when necessary.
- Filters - If you're searching for a medication and only want to see options available for office use, you can use the "Available for office use" filter in the search menu to limit your results.
Office Stock Availability
This Guidance may affect compounded medications you have previously ordered for office use. Most of our formulary is still currently available for office stock ordering. We've compiled a list of the top compounded medications ordered for office stock. View that list here.
Available for Prescription Only
Bulk Drug Substances Reviewed and Not Listed are available for patient-specific prescription only.
Compounded medications that do not appear on any FDA list are available for prescription only.
Full list of drugs currently available for prescription only:
1. Bulk Drug Substances Reviewed and Not Listed
Available for Office Use and Prescription
Bulk Drug Substances on FDA’s List of Office Stock Drugs and medications Under Review may continue to be ordered for office use or prescriptions.
Compounded medications prepared at 503B outsourcing facilities View Full List Here
Full lists of drugs currently available for office use and prescription:
FDA Seeking Veterinarians' Input
Wedgewood Pharmacy has been the leader in submitting drug nominations, with nearly 200 drugs already submitted, and many more underway, but the FDA wants to hear from YOU. They're asking veterinarians to comment on the docket identifying what medications compounded from Bulk Drug Substances are essential to have for office use. We've outlined the easiest way to leave a comment here.
News and Resources
Top Office Stock Medications Download Now
ON-DEMAND WEBINAR: GFI #256: Your Guide to Practice Preparedness Watch Now
VIDEO: Protecting Your Access to Compounded Medications Watch Now
2/24/2023: FDA Statement on 503B Outsourcing Facilities Currently, GFI #256 will not be enforced at 503B Outsourcing Facilities.
Medical Rationale Examples Download Now
1/15/2023: The FDA Wants to Hear From You! FDA is asking veterinarians to submit comments about compounded medications for office use. Read More Here.
GFI #256 Basics Download Now
GFI #256 Frequently Asked Questions View Now
VIDEO: GFI #256 - What You Need to Know Watch Now
FDA's Adverse Event Reporting Download Form
When a medication becomes "Reviewed and Not Listed", that medication will be available to order for office use for 60 days. After those 60 days, that medication will be available with a patient-specific prescription only.
To order, you can:
- Log in to your existing WedgewoodPharmacy.com account
- Create a new account on our digital ordering platform
- Fax a prescription to 800.589.4250.
- Call 800.331.8272 to speak with one of our customer care specialists.
We continuously update our ordering tools to reflect all the regulatory guidance and requirements issued by FDA and State Boards of Pharmacy.
Our digital ordering tool has been updated to include features such as filtering for medications available for office use and providing a list of medical rationales to choose from when necessary.
FDA wants to hear from veterinarians about why you need specific medications for office use. We have developed clear, simple guidelines for you to do so here. We suggest that you focus comments on explaining to FDA why you have a clinical need to have specific drugs that FDA has not approved for office use or why it is important for you to have on hand drugs that are currently “under review.” Keep in mind when commenting that GFI #256 does not “take away” your access to specific compounded medications. GFI defines which medications can be made for office use versus which must be prescribed for individual patients.
Can't find the answer to your question? Our general counsel, Barry Siegel, is available to answer GFI related questions. Please send your inquires via email to email@example.com