Please read this entire alert carefully!
The next time your pet gets sick, will you have access to the unique treatment options that compounding pharmacies provide? The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) recently issued a Compliance Policy Guide (CPG) on compounding for animals that threatens the ability of pharmacists to continue compounding medications for veterinary patients. We need your help to ensure that this extremely restrictive guideline is withdrawn.
This new FDA issued guideline if implemented would force pharmacies to stop compounding many medicines for animals. In addition, this guideline is much more restrictive than the FDA’s policies governing compounding for human patients! Also, many of the compliance policy guide provisions should clearly not apply to non-food producing, companion or exotic animals. We need your help to get rid of the parts of this guideline that would prevent your pet from getting its medicine.
Attached to this letter is a simple form you can complete to help ensure that you will still be able to get customized medicines for your pet. The form is very simple and only takes a minute to complete.
If you have any questions please ask for one of our compounding pharmacists. He or she will be glad to help answer any questions you might have.
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SUBMITTED VIA FAX
(301) 827-4401
_____________
(Date)
Stephen F. Sundlof, Director
Center for Veterinary Medicine
U.S. Food and Drug Administration (HFV-1)
7500 Standish Place
Rockville, MD 20855
Dear Dr. Sundlof:
My pet __________________________, a ____________________________, receives
(Pet’s name) (Type of animal)
______________________________ medication from a compounding pharmacy to treat
(Name of medication)
______________________________ condition.
(Animal’s condition)
My pharmacist must use bulk drug substances to compound this medication for
my pet. Without this medication, ________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
(Describe how your pet would suffer or how your life would be more difficult without the medication.)
Please ensure that FDA’s guidance and regulations for veterinary compounding do not prevent my pharmacist
from being able to customize medications for my pet. The current compliance policy guide for veterinary compounding
is problematic and I support my pharmacist in asking that it be withdrawn.
Sincerely,
________________________________
(Name)
__________________________, ________________
(City) (State)