FDA’s GFI #256 is here. It’s real. It’s different. We’re here to help.
FDA has finalized GFI #256,
Compounding
Animal Drugs from Bulk Drug Substances, and it is slated to be enforced
beginning October 1, 2022. [Extended by FDA to April 2023.] This Guidance means that some of the ways
veterinarians order compounded medications will change, including what can be
ordered for office use and what will require a patient-specific prescription.
There are also additional documentation requirements for veterinarians,
including determining a clinical rationale and adverse event reporting.
Almost all medications prepared by Wedgewood Pharmacy and our Wedgewood Connect
outsourcing facility are compounded using Bulk Drug Substances (BDS) because
that is best pharmacy practice and the most scientifically sound way to ensure a
consistent, quality compounded medication. In short: we have a vested interest
in ensuring that we, and thus our veterinary customers, comply with the new
guidelines established by GFI #256.
Here are three facts veterinarians will want to know about GFI #256.
The rules are complicated, but we make compliance simple.
- FDA has established four dynamic lists that define which BDS in which
forms may or may not be used to compound for office use for different
species. We are constantly monitoring these lists. We also are leading the
industry charge to nominate drugs to ensure that the medications our
customers and their patients need are being placed on a positive list by
FDA. (If you are responsible for long-term inventory management for one or
more practices, you may want to become familiar with the FDA’s lists. Don’t
worry: you’ll find links to all of the lists and other resources in our
GFI #256 resources center.)
- For medications made from BDS prescribed for individual patients
pursuant to a prescription, veterinarians will be required to specify that
there is a clinical difference supported by a medical rationale for why the
compounded medication is needed instead of an FDA-approved drug. FDA has
provided easy-to-understand examples. We’ll make specifying a medical
rationale easy in our prescription tools.
- Veterinarians also will be required to report adverse events and product
defects to FDA using a specific form or electronic tool. We’ll provide the
form
and links to the tool.
We have you covered. We will ensure you are informed and prepared for
compliance.
We make it easy for our veterinary customers to comply with the new guidance.
We have world-class information technology systems in place. These ensure that
when our customers order or prescribe from us, through any channel, we comply
with the Guidance, state, laws, regulations, and codes that apply to compounded
medications. For example, we know which 14 states limit ordering for office use
and what those limits are. When veterinarians order or prescribe a compounded
medication from us, they can rest assured that compliance with GFI #256 (and all
other applicable laws, rules, and regulations) is built into our systems—and our
psyches.
Change can be difficult. We’re committed to helping veterinarians navigate
in the new GFI #256 environment.
We have invested heavily in adapting our ordering and prescribing systems to
the new guidelines in GFI #256. For example:
- When a prescriber is required to determine a clinical difference
supported by a medical rationale for a prescription of a compounded
medication, we will prompt them to make this determination, along with a
list of typical justifications.
- We also have provided intensive training to our Customer Care
professionals and sales professionals so they can guide our veterinary
customers to make sound, compliant choices.
- Yes, there may be some surprises and disruptions to “business as usual,”
as all of us to adapt to the guidance. But Wedgewood Pharmacy is committed
to help our customers get it right, and make it easy, every time.
What’s next?
Contact Wedgewood Pharmacy:
GFI #256 is real and complicated. We make compliance simple.