The voice for compounding pharmacy  |  March 6, 2020
ReedSmith submits GFI #256 comments on coalition's behalf
In a letter to the FDA on behalf of a coalition of compounding pharmacies, attorney Rachael Pontikes of ReedSmith LLP requests a withdrawal of FDA's draft GFI #256 related to animal compounding and urges that FDA "consider engaging in further dialogue" with industry stakeholders "on the best path forward to appropriately regulate veterinary compounding." The letter makes the case that FDA has no authority to regulate veterinary compounding; that FDA is practicing medicine by attempting to regulate veterinarians; and that the regulatory scheme envisioned by GFI #256 will have a severe negative impact on animal health.