Compounding Pharmacies are specialized pharmacies able to address specific health needs in a way mass produced pharmaceuticals cannot. Compounded medications offer customized solutions for patients’ unique conditions. The value of these facilities is significant for those who have experienced an enhanced quality of life or life-saving benefits from compounded medications.
In January 2017, the former compounding pharmacy executive from the now defunct New England Compounding Center was sentenced by a federal jury in Boston to nine years in prison on racketeering and fraud charges for his role in a drug contamination case going back to 2012.
According to quotes from victims and families of victims, the defendant’s sentence did not meet the crime. The prosecution wanted a second-degree murder charge conviction. Toxic steroid injections from the filthy compounding pharmacy, which was illegally operating as a full-fledged drug manufacturing plant, caused a meningitis outbreak resulting in 76 deaths and more than 800 sickened patients scattered throughout 35 states.
Unfortunately, the outbreak could have been averted had the company adhered to and enforced chapter <797> of the United States Pharmacopeia. USP <797> establishes best practices and regulations for the production of compounded sterile preparations in order to ensure patient safety and prevent harm.
The spotlight on the Compounding Pharmacy industry since the infamous tragedy of 2012 has not dimmed. In 2013, President Barack Obama signed a bill granting the Food and Drug Administration (FDA) more regulatory powers over drug compounding pharmacies.
Currently, the USP <797> is undergoing its first revision since 2008. The proposed revision, major in scope, spurred thousands of responses during the public commentary phase which ended January 2016. Proposed revisions, in part, look to re-categorize compounded drugs, now broken into three risk levels, by differentiating based on the BUD (beyond use date) and the environment in which the product was compounded. Also among the changes is the increase in frequencies for environmental, personnel and viable bacterial monitoring.
Many in the industry are stepping up protocols to reflect the proposed changes to USP <797>. Some have adopted a “wait and see” stance. Even if the USP committee presents a second revised proposal for public comment, it stands to reason any changes will be more stringent than what is currently in place.
Whatever the stance, Hardy Diagnostics is well poised to offer compliance solutions with our HardyVal USP <797> compliance kits. Our ISO 13485 GMP media manufacturing facilities set us apart, giving us the ability to provide quality products directly to the compounding pharmacy. Our staff includes a Technical Support team of microbiologists and a full-time Product Manager for USP <797> affairs.
As USP <797> compliance specialists in microbiology, we see our role as assisting our pharmaceutical lab partners in their most important mission: to ensure a safe end-product for patients.
Learn more about Hardy Diagnostics’ full offering regarding USP <797> and compounding pharmacies at HardyVal.com