Prioritize FDA Inspection Readiness

A decade ago, questions still lingered among pharmacies concerning whether FDA had a legal right to conduct an inspection of their facility. After all, Section 704 of the Federal Food, Drug, and Cosmetic Act (FDCA) seems to exclude (at least to a degree) a pharmacy from FDA’s inspection authority, and compounding pharmacies typically were regulated solely by state boards of pharmacy. After the compounding disaster in 2012 involving New England Compounding Center (NECC), however, FDA made it abundantly clear—through words and actions—that it has full legal authority to inspect pharmacies