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Can FDA observations lead to reprimands of pharmacists?

The United States Food and Drug Administration (FDA) conducts investigations of certain pharmacies to determine whether or not the facility’s practices are in line with Food Drug and Cosmetic (FD&C) Act and related laws. The FDA’s Offices of Regulatory Affairs inspectors conduct the investigation and make observations about practices within the pharmacy, noted with FDA Form 483. The observations within this form are based on the “investigator’s judgment, conditions, or practices observed” that could indicate a potential violation.

Upon completion, the FDA sends the form to the facility’s management. The FDA admits the form is not a final determination of wrongdoing. However, the information within these forms can cause damage to the pharmacy and the professionals who work there.

A recent National Association of Boards of Pharmacy (NABP) meeting discussed the use of these forms and how they can result in inappropriate reprimands. The group stated the FDA “frequently” conducts these inspections and often posts the results of the inspections online. State licensing boards can access this posting and use the information to take administrative or disciplinary action against a pharmacy without the addition of their own investigation. The NABP acknowledges that this is an important distinction, as an investigation conducted by state board officials would use specially trained and/or authorized inspectors. As a result, the group has called on state boards to follow a more regimented practice when using information from these forms.

This is just one methods state boards use to reprimand pharmacies and pharmacists. Those who are investigated and accused of a violation can seek legal counsel to help protect their interests.