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Safety & Quality

Quality is Our Standard

RXQ Compounding has been serving physicians, hospitals and surgery centers as an FDA Registered 503B Outsourcing Facility since 2014.

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-art 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).

End Product Testing

All RXQ Compounding products, sterile and non-sterile, are end-product tested prior to being released for in-office use. Product testing is completed in regulation of FDA guidelines to ensure safety and compliance.

 

Sterile Product Testing

All sterile products produced by RXQ are end-product tested for:

  • Sterility
  • Endotoxin Content
  • Particulate Matter
  • Component Drug Potency

 

Non-Sterile Product Testing

 

Creams

  • Potency, pH / Appearance
  • Microbial Enumerations
  • Objectionable Microorganisms
  • Content Uniformity

Suspensions

  • Potency, Microbial Enumeration
  • Objectionable Microorganisms
  • pH / Appearance
  • Container Closure Integrity
  • Content Uniformity

Solutions

  • Identification of Objectionable Microorganism
  • Potency
  • pH / Appearance
  • Microbial Enumeration
  • Container-Closure Integrity