We also provide assistance with FDA inspection responses for 503A pharmacies as well as assist with the PCAB accreditation process.
A benefit for a pharmacy to become 503B registered is that the facility deals directly with physicians’ offices and can convert the business model to cash rather than dependent on billing patients’ insurance. Even though some states allow for office-use compounded preparations, the FDA doesn’t allow 503A pharmacies to prepare compounded products for office-use administration without a 503B registration.
Along with avoiding the cumbersome paperwork associated with patient-specific prescriptions, physicians’ typically order in bulk providing 503B facilities with a larger cash flow.