How the FDA’s new guidance will affect you.
New rules are now in effect for compounding in animal health. GFI #256, the U.S. Food and Drug Administration’s new guidance for compounding veterinary drugs from bulk substances, went into effect at the beginning of April. We reached out to Marcy Bliss, CEO of Wedgewood Pharmacy, for details about what this means for your practice.
Q: What is GFI #256?
A: GFI #256 is the FDA’s current thinking around medications compounded from bulk drug substances. The guidance permits the clinic to stock compounded drugs made from bulk drug substances only if those medications are nominated for review and categorized either as “under review” or “reviewed and listed” by the agency. FDA will also permit, until further guidance is issued, medications prepared in a 503B outsourcing facility to be ordered for office stock. All other compounded medications will require a patient-specific prescription and most will require a medical rationale. But don’t panic. 86% of the medications we commonly receive office stock prescriptions for are either “under review” or “listed” at the current time. The lists are dynamic, and we expect them to change frequently. The GFI will also require adverse event reporting.
Q: Why did the FDA decide to implement this?
A: FDA cited safety concerns as well as their intent to protect drug manufacturers and the new drug approval process.
Q: What impact will GFI #256 have on veterinary practices?
A: In a nutshell, what is changing is HOW you can order a compounded medication, but not WHAT you can order. The FDA has established lists that define which compounded preparations will be available for office use, also known as office stock. Office stock can be administered or dispensed to patients with a VCPR.
- Medications on FDA’s list of office stock drugs and medications currently under review may be ordered for office use and patient prescriptions.
- Medications that have been reviewed and not listed may be prescribed for patients and are not available to order for office use. Veterinarians may be required to provide their medical rationale with these prescriptions.
- Medications that have not been nominated, and therefore have not been reviewed by the agency, may only be provided via prescription as well.
Veterinarians and pharmacists will be required to report adverse events and product defects to FDA using a specific form or electronic tool.
Q: Which drugs are affected?
A: All drugs compounded using bulk drug substances fall under this guidance. FDA has lists which detail which drugs are available for prescription only, and which are able to be ordered for office stock. The three lists are:
- Under Review (office use permitted),
- Listed (office use permitted), and
- Not Listed (patient-specific prescriptions required).
These lists are fluid and are likely to change going forward. Drugs prepared under cGMP in FDA-registered outsourcing facilities are also available for office use.
Q: What solutions does Wedgewood offer for PSIvet members?
A: Wedgewood Pharmacy has been leading the way in advocacy and education surrounding GFI #256.
Our team has nominated nearly 200 product families (pharmaceutical ingredients, various dosage forms and strengths, for various species) to ensure you have access to as many medications as possible.
We created this digital resource page as your go-to source of GFI #256 news, updates, and information.
In addition, we have built compliance into our technology, as we do with state and controlled substance regulations, to make it as easy as possible for veterinarians to navigate the new rules. The technology starts with the digital search process. When a veterinarian or technician searches for a medication, they will easily see if it is available for office stock AND prescription, or patient-specific prescription only. In addition, we’ve developed a simple drop-down menu to make it easy to communicate your medical rationale. We’re constantly monitoring and updating the FDA lists so that veterinarians don’t have to.
Q: What can PSIvet members do about this?
A: One concern I have right now is that FDA is moving more and more of the office use nominations to the “reviewed and not listed” list. In other words, CVM is looking at our reasoning for office use availability and saying “no.” This is where you as a veterinarian can make a difference. FDA indicated to us that they want to hear from veterinarians the clinical reasons of their medical rationale as to why they need compounded medication in their office, and why alternatives aren’t ideal for those unique patients.
Your voice can make the difference. You can visit the FDA docket to comment on drugs that are under review or have been reviewed and not listed. Write your comment using the name of the bulk drug substance (BDS) about which you’re commenting and include examples of the impact on patient health if the medication was not available for office use. Visit this page for more information on how to submit a comment on the docket.
To learn more, visit https://info.wedgewoodpharmacy.com/gfi.