LyceumCE is all about Quality Improvement

Hi, my name is Seth DePasquale. I’m a Board Certified in Sterile Compounding Pharmacist. I’ll give you a little bit of background on myself, but this really isn’t about me, so I’ll make it brief. I’ve been working in compounding since 2014 at a facility that compounds high risk injections for horses. Soon after I began to write about compliance issues within compounding on my site pharmacyinspection.com, then started a podcast of the same name. Not long after that I started making videos SHOWING people how to comply with standards.

But like I said, this isn’t about me. My goal with LyceumCE is to promote compliance within compounding, both sterile and non-sterile. I’ve learned quite a bit over the years through consulting others and seeing the challenges compounding facilities face in their operations (even the challenges in my own!). I’ve found that education for sterile compounding is either kind of dry or extremely expensive to go on site and learn in person. So I’ve tried to come up with innovative ways to teach others the standards themselves and the exact ways on how to comply with them.

In this blog we’re going to explore various 483’s, which are simply observations that the FDA has made on individual facilities and their non-compliance with either USP <795>, <797>, <800> or cGMP. Through this exploration of other operations I hope to highlight some of the ways to improve your operations and learn not just the standards and how to comply but WHY you should comply with them. This “how” and “why” are extremely important. It’s what sets Lyceum’s offerings apart from other programs.

One thing I want to make clear is that this isn’t meant to point out the faults in other facilities in order to show how non-compliant compounding pharmacy is. As a compounding pharmacist myself, I too have been inspected by multiple boards of pharmacy (including Kentucky, California and the National Association of Boards of Pharmacy) and faults have been found in my own operation. The results are what matter. What you do with the information from an FDA 483 or State board inspection; how you correct those non-compliance issues are what matter. This is intended to be used as a learning tool to improve the quality of your compounding operation.

LyceumCE is also an accredited ACPE provider of continuing education for pharmacists and technicians. These posts (and soon to be released podcast) will be turned into learning modules for CE credit. Again, the goal of LyceumCE is to promote the compliance with the standards and SHOW people how to comply with them. If we fall short of this in any of our programs, we’d like to know, which is one of the main reasons why we became an accredited provider. To get feedback from learners on our educational offerings.