Compounding Pharmacies in a More Regulated World

With the new USP <797> chapter now official, here is how to address regulatory expectations and ensure patient safety

This is the fourth and final piece in a series about regulatory updates in the compounding pharmacy industry.

So, November 1 has passed and you’re admiring all the work you’ve done to comply with the newly official version of USP <797> Pharmaceutical Compounding – Sterile Preparations. What’s that? Oh, you’re still looking for ways to streamline your micro QC processes to handle increased testing requirements. That's great that you're still looking to improve your workflow! It’s also important to remember that USP chapter requirements are seen as the minimum to ensure patient safety.

The team at Microbial Solutions put together a great series on USP <797> changes. Let’s review the series to help you identify areas you can target for improvements.

Part 1: Environmental monitoring lessons learned from tragedy

The first article of this series reviewed the tragic contamination event at the New England Compounding Center (NECC), regulatory enhancements that came from the fiasco, and some challenges the industry still faces today. While the compounding industry continues to grow and face new (and sometimes not-so-new) challenges, new regulations and resources have since been created to further define regulatory expectations that ensure the safe compounding of medicines.

According to the NECC’s 483 issued on Oct. 26, 2012, one of the many unmet expectations at the company was the failure to identify microorganisms found in their facility and subsequently investigate those findings. (As an interesting side note, 483s from any company in general are a good way to figure out what not to do). If you found a gap in your microbial identification strategy, you may be wondering what the best practices are or what guidelines to follow. The short answer? Get an accurate identification.

It’s obviously more complicated in practice, but accuracy is critical. Accurate identification of microorganisms improves reporting capabilities, facilitates full investigation of root causes for contamination and informs decision-making. With accurate data, it is possible to fully understand issues that arise and develop meaningful corrective and preventive actions to reduce production down-time and increase patient safety. Read more >