Are You Ready for Inspection?

Have you ever encountered a situation where you thought and said to yourself, “this could not happen at a more inopportune time”? It perfectly describes Board of Pharmacy and other regulatory agency inspections. They come like the proverbial thief in the night, completely unexpected and unannounced.
With rules and regulations constantly changing, it is difficult, even for the most vigilant and attentive operators, to stay abreast of ever-changing state and federal laws and associated regulations. Combine the difficulty of staying aligned with the dynamic nature of regulatory changes with human nature’s characteristic inclination and tendency toward complacency and you are positioned to be unprepared for an inspection. As we all know, whether it’s a Board of Pharmacy, FDA, or DEA inspection, these inspections rarely result in total compliance no matter how diligently pharmacies are operated.
Knowing what inspectors focus on during an inspection can mitigate penalties and consequences that may ensue after an inspection. Board of Pharmacy inspections can result in substantial financial penalties. DEA and FDA inspectors often conduct their inspections accompanied by Board of Pharmacy officials. The penalty costs of inspections are aggravating and distasteful. They can exceed thousands of hard earned dollars.
A poor inspection can have other more deleterious financial consequences that may not, at first glance, be as obvious. Dismissal or expulsion from contracts and networks, outright impediment to inclusion in certain networks, contracts, and programs are unforeseen, devastating, and long-lasting outcomes of a bad inspection. Pharmacy is so very regulated and controlled by various organizations and groups. Because of this, it is imperative that inspection results be more than just substantially compliant.
An introspective analysis for compliance with all regulatory matters can result in sizable savings of capital. By being proactive and investing time and capital to assure compliance, before the unexpected presents itself, you will avoid the pitfalls that complacency presents.
Can you honestly say that you are ready for an inspection at any point in time? We can assist you in being better prepared. Give us a call.