Chuck Leiter wants to make it known that his family-owned business does not operate like the New England Compounding Center. NECC produced compounded drugs in such high volumes that some groups argue it was a drug manufacturer, not a compounding pharmacy, and should have been under stricter regulation. Unlike drug manufacturers, which are regulated by the FDA, compounding pharmacies usually fall under state pharmacy boards' jurisdiction. The FDA can step in if it has concerns about a compounding pharmacy, such as misbranding or adulteration.
