Regulatory Compliance


• FDA registered 503B Outsourcing Facility

        – Maintain USP 71 Sterility Standards
        – Perform batch potency tests
        – Ensure sterility via membrane 
filtration
        – Perform Extended Beyond Use 
Dating Testing
        – Exceed USP 797 Standards

        – Maintain ISO Class 7 Buffer Environment
• State Licensed 503A Pharmacy
        – Dedicated secondary location
        – Maintain ISO Class 7 Buffer 
Environment housing an ISO Class 5 Horizontal Laminar

           Airflow Bench
        – Utilization of sterile API’s and sterile product and equipment to ensure patient safety
• ISMP Safe Labeling and Barcoding
• USP 797 Quality Standards
• ASHP Policy Compliant
• Transparent Quality Reporting