#compounding

What does 503B compounding mean for the future of veterinary medicine?

Modern compounding—often referred to as 503A—is a niche business, providing patient-specific formulations to satisfy individual needs. Because commercially available drugs are marketed almost exclusively for humans, compounding has become an essential resource for veterinary medicine. Veterinarians often depend on 503A pharmacies to provide preparations at lower concentrations and in more palatable dosage forms to optimize treatment for their patients. However, without proper management and regulations, 503A compounding can potentially be detrimental. Presently, 503A pharmacies are not required to adhere to Current Good Manufacturing Practice (cGMP) objectives put forth by the U.S. Food and Drug Administration (FDA) to ensure pharmaceuticals achieve a specified standard of safety. The quality of products produced in a 503A facility depend on the pharmacy's voluntary conformance with cGMP, which can be substantially cost-prohibitive, requiring anywhere from $50,000 to $100,000-plus of investment for a single formulation. Testing on raw materials and finished products may be performed to an extent depending on the facility, but the data are often incomplete, testing only one or two factors while omitting others that would affect the product's overall quality. The variability of cGMP compliance from pharmacy to pharmacy paves the way for omissions in procedures that can lead to patient harm. …