Safety and Certifications
Our Guarantee
Quality | Compliance | Accountability
At ProRx, patient safety is at the heart of everything we do. As a trusted 503B outsourcing facility, we uphold the highest standards of quality, compliance, and accountability to ensure providers have confidence in every product we deliver. Underscoring our unwavering commitment to safety and regulatory excellence, ProRx has earned the DEA Controlled Substances Registration Certificate—an achievement that is especially rigorous for 503B facilities and reflects the strength of our processes, security, and compliance culture.
Commitment to Safety
From raw ingredient sourcing to sterile compounding and final distribution, our processes are built on rigorous controls and oversight. Every cleanroom, every batch, and every protocol reflects our commitment to delivering safe, consistent compounded preparations to healthcare providers and their patients.
- State-of-the-Art Cleanrooms: ISO-classified environments designed to meet or exceed USP <797> and USP <800> requirements for sterile compounding and handling of hazardous drugs.
- Automation and Robotics: Advanced compounding systems reduce variability and enhance accuracy, lowering risk of human error.
- Environmental Monitoring: Continuous monitoring of temperature, humidity, pressure differentials, and airborne particulates ensures conditions remain within validated parameters.
- Stringent Quality Testing: Every batch undergoes sterility, potency, endotoxin, and particulate testing in accordance with FDA current Good Manufacturing Practices (cGMP).
Certifications and Registrations
ProRx maintains all certifications and registrations required to operate at the highest level of compliance, including:
- FDA 503B Outsourcing Facility Registration – Ensuring compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act and current Good Manufacturing Practices (cGMP).
- DEA Controlled Substances Registration Certificate – Authorizing ProRx to securely handle, compound, and distribute controlled substances.
- State Board of Pharmacy Licensure – Approved to serve healthcare providers nationwide.
- cGMP Compliance – Strict quality systems aligned with FDA inspections and regulatory guidance.
Why it Matters
Certifications aren’t just about compliance—they’re about trust. Providers rely on ProRx to deliver sterile and nonsterile preparations that are not only effective but also compounded under the most stringent safety and regulatory standards in the industry. By choosing ProRx, you can be confident that every product is backed by science, integrity, and accountability.