In Connecticut, what is a pharmacy that dispenses compounded sterile preparations (CSPs) without a prescription classified as?

In Connecticut, a pharmacy that dispenses compounded sterile preparations (CSPs) without a prescription is classified as a manufacturer. This classification is significant because it highlights the regulatory requirements and the nature of the activities being conducted by the pharmacy.

When a pharmacy compounds sterile preparations without a patient-specific prescription, it transitions from a traditional pharmacy role into that of manufacturing. Manufacturers are subject to stricter regulations, including compliance with Good Manufacturing Practices (GMP) as established by the FDA. The distinction is crucial because it ensures that compounded medications are produced in facilities that meet these heightened quality standards to ensure patient safety.

In contrast, licensed pharmacies typically dispense medications against valid prescriptions and are primarily regulated under pharmacy practice laws. Exempt facilities and non-compliant pharmacies denote statuses that involve different regulatory implications and do not apply in the same way to those involved in manufacturing CSPs without prescriptions.