Maintaining a strong state-of-control for the highest quality & compliance

It is critical to have the right 503B partner now, and for the future—one that has the expertise your hospital can depend on for the highest quality and compliant compounded sterile products (CSPs).

How can you be sure the outsourcing facility(ies) you use now, or are considering for the future, meets the increasingly demanding and stringent FDA requirements for 503B sterile compounding?

This 503B Outsourcing Facility cGMP Checklist is a good place to start.


With evolving and increasingly strict compounding regulations and guidelines, hospitals need a reference for how to evaluate their current and future 503B outsourcing partners through the lens of cGMPs—ensuring that these partners have quality processes and controls in place to deliver safe compounded sterile injectable products. Given QuVa Pharma’s known expertise in cGMPs and our pharmaceutical manufacturing background, our Partner Hospitals—and potential customers—asked us to develop a list of questions to ask to help them verify that their 503B outsourcer is able to meet their needs today and in the future. They have told us that this checklist is invaluable; we believe it will be helpful to you as well. 

The checklist details questions to ask for many key areas:

  • Sterility Assurance Program
  • Licensing & Registration
  • Labeling & Packaging
  • Quality Control
  • and more…


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