Can a pharmacist deny access to an FDA inspector?

A pharmacist cannot deny access to an FDA inspector because federal law grants inspectors the authority to enter and inspect healthcare facilities, including pharmacies, during business hours. This access is necessary for the inspectors to ensure compliance with regulations that protect public health and safety. When FDA inspectors arrive for an inspection, they are performing a critical function, and the law requires pharmacists and pharmacy personnel to provide the necessary access to facilitate these inspections without undue delay.

Recognizing the importance of regulatory oversight, pharmacies are obligated to cooperate fully with FDA inspectors. This cooperation includes providing the inspectors with access to records, equipment, and any other areas relevant to their inspection. Therefore, denying access to an inspector would not only violate federal regulations but could also lead to significant legal repercussions for the pharmacy and the pharmacist involved.

The option that suggests access could be denied based on a pharmacist being busy, the inspector's attire, or during certain hours indicates misunderstandings of the regulatory requirements and the responsibilities of pharmaceutical professionals in ensuring compliance with federal laws.