What does it mean to be a 503B Outsourcing Facility

A 503B outsourcing facility is registered with the FDA and is authorized to compound sterile medications in large quantities for healthcare providers. Unlike traditional compounding pharmacies, 503B facilities comply with stringent Current Good Manufacturing Practices (cGMP), similar to pharmaceutical manufacturers.

This certification ensures:

• High Quality and Safety: Medications meet strict FDA oversight and quality standards.
• Bulk Production: Providers can order compounded medications without individual prescriptions for each patient.
• Consistency and Compliance: Reliable, standardized formulations with rigorous testing and documentation.

For providers, partnering with a 503B Outsourcing Facility means access to safe, compliant, and scalable medication solutions tailored to your needs.