Breaking: Pharmacy Coalition Pushes Back on FDA Draft GFI #256
Wedgewood Pharmacy and several other pharmacies that specialize in preparing compounded medication for animal patients submitted formal comments today to FDA about its proposed guidance, Compounding Animal Drugs from Bulk Drug Substances.
The comments make the case that FDA should leave the regulation of the professional practices of veterinary medicine and veterinary compounding to states. Rigorous state laws already ensure quality and compliance, serve the unique needs of animals and veterinarians, ensure access, and maintain low costs. It’s key arguments:
- FDA has no authority to regulate compounding for animal health;
- FDA is practicing medicine by trying to regulate the practice of veterinary medicine; and
- The regulatory scheme proposed in GFI #256 will have a severely negative impact on animal health.