Compounding pharmacies is a growing segment of the industry with continuing emerging regulations. The ever-evolving landscape of industry regulations requires strict monitoring of quality standards. Regulatory Compliance Associates® Inc. is a leader in both aseptic drug manufacturing and the compounding pharmacy industries. Our regulatory experts can guide these entities to ensure they demonstrate compliance with new federal compounding industry regulations and meet the most Current Good Manufacturing Practices (cGMP) guidance requirements. We can also prepare and train personnel in the management of FDA follow-up inspections.
RCA can help your company strategically address regulatory issues and help you establish a robust quality system designed to meet current FDA expectations for 503b compounding pharmacies. We do this through:
- Comprehensive Baseline Reviews
- Review and Guidance with Product Labeling Requirements
- Preparation, Management, and Response to an FDA Inspection
- Re-engineering of a Facility (if needed)
- Development and Documentation of Processes and Procedures