FDA guidance continues to affect the availability of certain compounded medications for office stock. Our full formulary remains available, and we’re here to help you navigate these requirements.
We make compliance simple.
FDA's GFI #256, Compounding Animal Drugs from Bulk Drug Substances, outlines requirements that impact veterinarians. Wedgewood has worked to make compliance as seamless as possible.
Updates to our digital ordering tool at Wedgewood.com:
- Rationales - When writing a prescription, we'll provide a list of medical rationales to choose from when necessary. Our ordering platform will show the BUDs for all medications. (If a medication is affected, you will see an alert!)
- Filters - If you're searching for a medication and only want to see options available for office stock, you can use the "Available for office use" filter in the search menu to limit your results.
Top Office Stock Medication
Know the Facts
Available for Prescription Only
All compounded medications are still available to prescribe. If a Bulk Drug Substance has been reviewed by the FDA and marked ‘Not Listed,’ it can only be prescribed. Any compounded medication that doesn’t appear on an FDA list are also limited to patient-specific prescriptions.
Available for Office Stock and Prescription
Bulk Drug Substances on FDA’s List of Office Stock Drugs and medications Under Review may continue to be ordered for office stock or prescriptions.
- List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals
- List of Bulk Drug Substances for Compounding Drugs for Use in Food Producing Animals or Free-Ranging Wildlife Species
- Nominated Bulk Drug Substances Currently Under Review
- Compounded medications prepared at our 503B outsourcing facilities
*Medications prepared at our 503B outsourcing facilities are prepared under FDA's cGMP standards.*
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 stock. We've outlined the easiest way to leave a comment here.
Frequently Asked Questions
View the below frequently asked questions regarding FDA's GFI 256.
What is FDA's GFI #256?
GFI #256, "Compounding Animal Drugs from Bulk Drug Substances," is FDA guidance that gives the agency’s current thinking about compounded animal drugs prepared with bulk drug substances. The guidance began being enforced on April 1, 2023. Wedgewood Pharmacy complies with the Guidance, and we encourage our industry partners to do the same.
How does it affect a veterinarian or someone who places office orders for a veterinary practice?
You may order medications made from bulk drug substances (BDS) for office stock if they appear on the FDA’s list of office stock drugs or on the FDA’s list of medications under review. You may not order medications on the FDA's list of medications reviewed and not listed for office stock. You may prescribe these medications for individual patients, and, in some cases, you will be required to provide a medical rationale for doing so. If you are required to provide a rationale for prescribing a medication made from certain bulk substances, Wedgewood Pharmacy’s digital ordering portal will provide a list of typical acceptable rationales from which you can choose.
Which medications made from bulk drug substances are now available for office use and which are available by prescription only?
Wedgewood Pharmacy has nominated nearly 200 bulk substances for consideration on the FDA’s list of medications approved for office stock. FDA has said that it will allow compounding for office stock from the substances that we and other organizations have nominated for review while they are under review. Here are the medications that FDA has “reviewed and not listed” for office-stock compounding, therefore requiring a prescription.
Are medications prepared at a 503B outsourcing facility going to be impacted?
Until further guidance is provided, FDA has stated that GFI #256 will not be enforced at 503B outsourcing facilities. Wedgewood Pharmacy's 503B outsourcing facility, Wedgewood Connect, currently offers over 70 preparations which will remain available for office stock, including critical office stock medications like Apomorphine, Cisapride, Metronidazole, and more!
What happens when the FDA deems a medication to be "Reviewed and Not Listed"?
When a medication becomes "Reviewed and Not Listed", that medication will be available to order for office stock for 60 days. After those 60 days, that medication will be available with a patient-specific prescription only.
How can I order from Wedgewood Pharmacy?
To order, you can:
- Log in to your existing Wedgewood.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.
What has Wedgewood Pharmacy done to be sure we are in compliance when ordering compounded medications?
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 stock and providing a list of medical rationales to choose from when necessary.
What can I do to ensure my practice has access to the compounded medications we need on our shelves?
The FDA wants to hear from veterinarians about why you need specific medications for office stock. 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 stock versus which must be prescribed for individual patients.
What's next?
Can't find the answer to your question? Our general counsel, Ben Daniels, is available to answer GFI related questions. Please send your inquires via email to hello@wedgewoodpharmacy.com
Can't find the answer to your question? Our general counsel, Ben Daniels, is available to answer GFI related questions. Please send your inquires via email to hello@wedgewoodpharmacy.com