Did You Know? that USP <797> mandates that all high-risk level compounded sterile pharmaceuticals prepared in groups of more than 25 identical individual, single-dose packages or in multiple-dose vials for administration to multiple patients shall meet a sterility test before they are dispensed or administered and that they shall be tested to ensure that they do not contain excessive bacterial endotoxins?
With the meningitis outbreak affecting hundreds of individuals and killing 36, it is important for physicians and patients to familiarize themselves with the proper guidelines for sterile compounding – especially regarding environmental monitoring and quality assurance testing.
New England Compounding Center – which shipped 17,000 vials of contaminated methylprednisolone acetate – allegedly dispensed product prior to receiving test results; which goes against the aforementioned USP guidelines. This tragedy has rightfully forced many compounding pharmacies that were not in compliance with regulatory bodies out of the business of supplying sterile compounded pharmaceuticals; while other compounding pharmacies (such as Hartley Medical) have further established themselves as the top providers of the highest quality sterile pharmaceuticals.
It is no secret that compounding pharmacies play a vital role in the medical community. They provide physician-prescribed volumes and concentrations that are not commercially available, offer customized treatment regimens for patients who have not responded to traditional treatments, and can assist in times of drug shortages. However, not all compounding pharmacies are the same. It is important for physicians to reduce the risk for both themselves and their patients by utilizing compounding pharmacies that go above and beyond the bare minimum to ensure safety and quality.
To supplement Hartley Medical’s USP <797>-exceeding environmental monitoring and quality assurance testing programs, William Stuart, RPh, President of Hartley Medical, continually places quality at the forefront of his practice by utilizing the most advanced technologies, equipment, and testing procedures. Hartley Medical tests products in its in-house quality assurance lab, which are backed by outsourced lab results, and stays current with the latest environmental monitoring procedures and technologies through William’s attendance at major educational conferences – most recently the Pharmaceutical Microbiology Forum’s Major Challenges in Environmental Monitoring conference in Las Vegas, NV.
Additionally, William recently co-presented on Compounding Pharmacies: Beyond the Meningitis Quandary with Dr. Joshua Prager at the 2012 North American Neuromodulation Society (NANS) meeting in Las Vegas, NV on December 9, 2012.
For William’s notations from both the environmental monitoring conference and the NANS Meeting, be on the look out for the January-February edition of The Hartley Standard – Hartley Medical’s bi-monthly e-newsletter.
For more on Environmental Monitoring and Quality Assurance, visit Hartley Medical’s Knowledge Center by clicking here.
Click the video image below to listen as William Stuart, RPh – President of Hartley Medical – gives his comments on the difference between price and value when analyzing compounding pharmacies.