Introduction

The recent spate of FDA activity has resulted in the need for pharmacies to understand how to adequately respond to the FDA and the public shaming (or more) that may ensue if companies do not meet FDA expectations.

Case Presentation:

It is routine for the state board of pharmacy to inspect pharmacies in order to ensure that they meet state requirements. However, after the NECC tragedy of 2012, the FDA received congressional authority to regulate certain pharmacies. To exert authority over potentially non-complying pharmacies, the FDA has also routinely joined representatives of the state board of pharmacy in their inspections.

If a pharmacy finds itself subject to a solo – or joined – FDA audit, it is important that the pharmacy know how best to respond to the FDA. It is generally understood that pharmacists understand that the FDA works in the best interests of patients but can often be overly cautious. This abundance of caution, while seemingly prudent, can be costly and even unnecessary. However, it is important to note that failure to satisfy FDA expectations may result in a simple warning, 483 response or warning letter but may lead to disqualifications, disbarments and even civil and criminal liability.

Management and Outcome:

In the event the FDA finds problems with your pharmacy, it is important that pharmacists understand that the FDA expects pharmacies to demonstrate that they:

  1. Understand the problem
  2. Have a commitment to fix the problem
  3. Have the resources to fix the problem

The FDA predominantly believes that such problems can be fixed by the use of CAPAs. CAPAs – or Corrective Actions and Preventative Actions – are important ways the FDA reviews a potential plan to address FDA findings. It is typical for pharmacists to address the immediate problems, e.g. Corrective Actions, but they routinely forget to address preventative action. While some companies do remember to use corrective plans such as training, the lack of specificity is often found wanting.

If the FDA has found your pharmacy to be wanting, it is important that you consider the ramifications and find legal counsel to appropriately respond on your behalf. If you have questions, please feel free to reach out to the Kulkarni Law Firm now.