Original webinar presented Tuesday, March 21, 2017
In this program, Dr. Fred Massoomi (PharmD, FASHP) will provide an overview of existing regulations and standards, and provide recommendations to minimize risks to patients.
Alarmingly, 64% of compounding sites are non-compliant with USP 797, according to the Pharmacy Purchasing and Products annual “State of Compounding” survey last year. Further, earlier this year only 48% of sites reported they are compliant with meeting USP 800 Handling Hazardous Drugs in Workplace Settings which goes into effect in 2018. Consider that 34 state boards of pharmacy require full compliance with USP 797 and 15 require partial or more stringent compliance, and only one state has not implemented state specific regulations.
Making the situation even more complex, FDA’s introduction of the 2013 Drug Quality Safety and Security Act added yet another dimension to existing regulations and standards. The Act introduced Title I: Compounding Quality Act and Title II: Drug Supply Chan Security Act. Additionally, over the past two years, FDA published for comment more than 15 Guidance Documents to revise or clarify the Compounding Quality Act with regards to sterile compounding.
We hope that you can join us, as this is a quickly evolving facet of pharmacy practice. It is critical for our patients that we get this right.