Compliance & Regulatory

Our solutions support compounding pharmacies operating under FDA regulations:

• 503A Compounding Pharmacies: Traditional compounding operations with patient-specific prescriptions
• 503B Outsourcing Facilities: Large-scale sterile compounding with enhanced FDA oversight
• Cold-Chain Standards: Temperature-controlled shipping that meets USP <1079> and USP <797> requirements
• Documentation: Complete chain of custody and temperature monitoring records
• Serialization: Track-and-trace capabilities for all shipments

We assist members with state-specific compliance requirements:

• Guidance on DBPR (Department of Business and Professional Regulation) documentation
• State pharmacy licensing and registration support
• Interstate shipping compliance for multi-state operations
• Board of Pharmacy audit preparation
• Ongoing regulatory updates and alerts

Comprehensive risk mitigation strategies:

• Insurance coverage for all shipments and products
• Contingency plans for weather events and carrier disruptions
• Product recall and retrieval protocols
• Cybersecurity measures for data protection
• Business continuity planning and disaster recovery

• ISO 9001:2015 quality management principles (alignment only)
• VAWD standards for wholesale distribution (alignment only)
• SOC 2 security best practices (alignment only)

We provide comprehensive support for regulatory audits and inspections:

• Audit-ready documentation and record retention
• Expert consultation during FDA or state board inspections
• Mock audit preparation and training
• CAPA (Corrective and Preventive Action) support
• Documentation templates and SOPs