Starting or expanding a business can be complex but starting a pharmacy or another health care facility has its own set of challenges. Owners must consider pharmacy and medical licenses, registrations, and other regulations in addition to typical business-related building and zoning permits. Those who are new to the process sometimes unintentionally overlook security protocols simply because they are unfamiliar with what is required. With nearly 20 years of experience inspecting pharmacies, I’ve seen these challenges play out in multiple ways.
For example, I once encountered a brand-new community pharmacy that was located inside a physician’s office without clear, physical separation between the two businesses. The alarm system was shared by the entire building, so the pharmacy was accessible to all employees, including the after-hours housekeeping staff. The door locks were insufficient as well; my team members and I easily bypassed them with an old Blockbuster Video card.
Our new Preoperational Inspection program can help pharmacies and distributors that are just starting out or expanding into a new facility. It’s meant for businesses that need a facility inspection to obtain a resident state license but are in a state whose board of pharmacy cannot conduct preoperational inspections.
The inspection is beneficial for a variety of scenarios. It could be useful for a pharmacy that has built a brand new, state-of-the art, sterile compounding facility with the intent to mail compounded preparations to all 50 states. Or it could help a large drug distributor that is moving its operations to another community. The program could help to ensure that security systems and alarms are in place before drugs and records are safely moved to the new address.
After NABP inspectors complete the Preoperational Inspection, the boards and state regulators will have comprehensive information they need about the facility, including:
- its physical structure, such as space, fixtures, and equipment,
- security features like locks and alarms,
- a list of anticipated onsite activities and scope of services, and
- accountability processes to ensure regulations are met.
This information can be used to evaluate if state minimum requirements are met for the facility to begin safely and securely storing drugs and records at the inspected location.
This newest offering in our portfolio of Accreditation and Inspection programs is yet another way we work with our member boards to ensure the safety and integrity of the nation’s drug supply chain. Want to find out if a Preoperational Inspection is right for your business? Fill out this interest form for more information.