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.]
We have adapted our ordering and prescribing systems and are training our
staff to comply with this new Guidance. Is your practice ready, too?
- 69% of your colleagues, in
our recent survey, said that they are not confident (24%)
or not at all confident (45%) that their practices are prepared to comply
with the provisions of the GFI #256.
Here are three things you can do today to be ready for compliance with GFI
#256.
Take stock.
Review the compounded medications you stock and frequently prescribe to
determine if and how you will need to change treatment protocols related to the
requirements of the Guidance.
- 65% of your colleagues have not done this and only 7% have
plans to do so; 20% say they’re not sure if this has been done.
For example, are the medications you stock for office use on a regular basis
currently on one of the FDA’s lists of Bulk Drug Substances (BDS) that are
approved or being reviewed for use in compounding for office use? Are any on the
not approved list? Bottom line: you may need to begin prescribing some
medications for individual patients. This step may require someone on your staff
to consult FDA’s lists, which change frequently.
See our resource page for
this and other information.
Ready your rationale.
Develop policies and procedures for how you will document your clinical
rationales for prescribing a compounded medication for an individual patient
instead of an FDA-approved drug.
- 72% of your colleagues have not done this, 18% aren’t sure if they
have, and only 5% have specific plans for doing so.
All our prescribing channels are ready to assist you in documenting clinical
rationale. We are working with the third-party vendors that submit prescriptions
from veterinarians to our systems to ensure that they integrate smoothly with
us. This includes both for orders directly on our own systems and those placed
through third-party vendors, for example, providing simple drop-down boxes you
can use to indicate your clinical rational for prescribing a compounded
medication.
Get ready to report.
GFI #256 requires that you report adverse events and product defects to FDA
using FDA form 1932A or
an electronic tool.
70% of your colleagues have not developed policies and procedures
for how they will report adverse events as specified in the Guidance; 17%
aren’t sure if they have, and only 6% have specific plans to do so.
What’s next?
Contact Wedgewood Pharmacy:
GFI #256 is real and complicated. We make compliance simple.