Commitment to Quality
RXQ seeks to conform to the highest standards of safety and quality in the industry and ensure compliance with federal and state laws and regulations. We apply numerous system controls and processes in our new state-of-the-facility to comply with FDA regulations for 503B Outsourcing Facilities including:
- 21 CFR Parts 210/211
- Sterile Preparation and the 2014 FDA Guidance for Industry
- Current Good Manufacturing Practice (cGMP) – Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
In providing sterile and non-sterile compounded preparations for patients, RXQ spends considerable effort and time maintaining and enhancing its Quality Management System (QMS).