Changes in FDA Compounding Guidelines could Drastically Alter Veterinary Pharmacy
A recent survey conducted by BusinessWire.com found that many veterinarians and veterinary pharmacists are concerned about new FDA guidelines that focuses on sources of ingredients of compounded preparations.
This new guidance requires compounded products for animals be compounded using only finished pharmaceutical products instead of bulk active pharmaceutical ingredients (API). This effectively limits the availability of what was originally 450 APIs down to only 7. This change is estimated to increase the price of compounded products for animals by 300% on average. In a market where pet owners are already paying large sums out of pocket for these specialized products, a 300% increase could push compounded medications off of the list of viable options for treatment. The survey of 1,849 veterinary professionals across the nation found upwards of 95% agreed that these new guidelines would have a negative impact on vet medicine overall.
Compounding in veterinary pharmacy is vital in order to maximize adherence in a population that is already very resistant to taking medications. Many veterinary pharmacies will compound flavored oral solutions/suspensions, transdermal gels, capsules that can be sprinkled into food, and even medicated treats. In a separate survey of veterinarians from late 2019, only 6.6% responded to rarely or never use compounded medications in practice. A large price increase in this market only means lower adherence and worsened patient outcomes.
While this guidance is not legally binding for the veterinarians or veterinary pharmacies, the FDA uses non-binding guidance as the basis for all its enforcement actions.
REFERENCES
- In New National Poll, Veterinarians Report That FDA’s Proposed Guidance Will Have a Significant Negative Impact on Animal Patients [news release]. Swedesboro, NJ; Jan 8, 2020. BusinessWire. https://www.businesswire.com/news/home/20200108005168/en/New-National-Poll-Veterinarians-Report-FDA%E2%80%99s-Proposed. Accessed April 7, 2020.
- How Veterinarians Use Compounding Pharmacy: 2019/2020 [survey]. https://www.mymedsmatter.com/sites/default/files/Veterinarian_Survey_2019_Results_010620.pdf. Accessed April 7, 2020.
