Compliance Blog for Pharmacies, DME facilities & O&P

Podcast: Non-Sterile Compounding | Pharmacy Compliance

Written by Becky Templeton | Wed, Jan 31, 2024

 

 

  
In this episode of "Becoming a Pharmacy Badass, Dr. Lisa Faast with guest Jeff Hedges, an expert in regulatory compliance for pharmacies will have an in-depth discussion focusing on non-sterile compounding regulations.

Key points covered include the importance of following the USP guidelines, the necessity of designated compounding labs, the requirements for negative pressure rooms, the use of specific personal protective equipment, and the significance of meticulous documentation, especially with master formula records and batch compounding records. The conversation delves into cleaning and deactivation requirements, emphasizing the need for stringent cleanliness in the compounding lab.

This episode stresses the complexity of managing all these requirements and encourages seeking expert help, like the services provided by Jeff Hedges and his team at RJ Hedges, to ensure adherence to compliance standards. They offer services that not only provide the necessary documentation and guidelines but also offer ongoing support and guidance for pharmacies to stay compliant.

This also highlights the rapid changes in compliance regulations, the need for ongoing training, and the significance of having a dedicated compliance officer or expert to ensure pharmacies stay up to date and follow best practices.

Overall, it emphasizes the importance of being proactive in maintaining compliance in the pharmacy setting, especially in the face of evolving regulations and increased inspection frequency by pharmacy boards.