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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:

  1. Rationales - When writing a prescription, we'll provide a list of medical rationales to choose from when necessary.
  2. 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 Use Filter

Office Stock Availability

Top Office Stock Preps

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.

List of Office Stock Preparations

Know the Facts

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:

  1. List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals
  2. List of Bulk Drug Substances for Compounding Drugs for Use in Food Producing Animals or Free-Ranging Wildlife Species
  3. Nominated Bulk Drug Substances Currently Under Review

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.

How to Leave a Comment

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

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 new FDA guidance that gives the agency’s current thinking about compounded animal drugs prepared with bulk drug substances. The guidance will be enforced beginning April 1, 2023. Wedgewood Pharmacy will comply 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 use 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 use. 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 use. FDA has said that it will allow compounding for office use 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-use 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 use, including critical office use 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 use 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 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.
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 use 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?

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.

What's next?

Contact Wedgewood Pharmacy:

  • Login to our veterinary professionals' website.
  • Take advantage of the resources of our general website.
  • Contact any member of our sales teams.
  • Call 1-877-357-6613.

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 hello@wedgewoodpharmacy.com

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Do you have more questions about GFI 256? Email our team and we'll do our best to incorporate your questions into future updates.

Ask us anything.