Compounding pharmacies ARE regulated by state boards, but whether or not compounding pharmacies have to be in compliance with USP 797 guidelines is completely up to those individual states. This creates a quality assurance disparity from state-to-state. Therefore, the question of, “Is simply meeting requirements good enough?” must be asked. In the wake of the nine deaths that occurred nearly seven months ago in Alabama that were linked to contaminated admixtures, the answer to this question has to be, “no.”
If a compounding pharmacy is meeting all of the requirements set forth by its state, but is still experiencing contaminated admixtures, then there is a major problem … especially for you and your patients. You obviously do not want to run the risk of putting contaminated “sterile” medications into your patients. Therefore, you must find those pharmacies that are exceeding standards – or even setting standards of their own – by performing at a level that is exceeding regulations in ALL states while simultaneously adhering to USP 797 standards; whether required or not.
In our past blog entry titled “4 Steps to Choosing the Right Compounding Pharmacy” (click here to read), I gave my recommendations for properly researching and selecting the right compounding pharmacy for your practice. In the article, I discuss the importance of doing a site visit – as you can directly see what goes on behind the scenes (and a pharmacy with nothing to hide should not deny this to you). Additionally, in Hartley Medical’s November-December 2011 newsletter, I included an article titled, “Would You Eat From This Kitchen” (click here to view the newsletter) where I discuss the importance of utilizing a “clean room” with an advanced sterile preparation environment cleaning program. I strongly urge you to read these two articles, as they can be extremely useful resources to help verify whether or not your current or potential compounding pharmacy is providing sterile medication of the highest quality possible.
Here at Hartley Medical, we provide the highest quality sterile preparations compounded in a state-of-the-art compounding facility that implements rigorous quality assurance and environmental monitoring programs. We pride ourselves in the fact that we exceed USP 797 guidelines on a daily basis.
If you have any questions about Hartley Medical and how we prepare our sterile compounds, or have questions about compounding pharmacy guidelines in general, I encourage you to use me as an immediate source of information. I am here for you, and I have nothing to hide.
The question is, “Do you know what your sterile compounding pharmacy is doing?”
D’Arrigo, Terri. “A Call to Action on Sterile Compounding Gains Traction.” Pharmacy Practice News. McMahon Publishing. July 2011: Issue 38. <http://www.pharmacypracticenews.com/ ViewArticle.aspx?d=Policy&d_id=51&i=July+2011&i_id=749&a_id=17543>. 7 Nov. 2011.