Alum and Nonsterile to Sterile Compounding

Published: February 16, 2021

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When Dr. Joe Kummer, Vice President of Engineering and Marketing at Edge Pharma, attended the American Society of Health System Pharmacists conference two years ago, he had a question. He asked the pharmacists he met if there was a need they had in the compounding space that Edge, as a 503B Outsourcing Facility, could tackle. He heard from several pharmacists that compounding alum – to be used for alum irrigation – was a difficult, complex, and time-consuming process. Could Edge Pharma develop a solution? Creative problem solving in the medical field is the crux of Edge’s mission. The team at Edge went to work.

Edge Pharma’s challenge was to create a product that made compounding alum, obtained in bulk as a nonsterile powder, easier for hospitals. Edge’s pharmacists and scientists developed a 30g/300mL sterile concentrated alum solution. The solution is compounded in Edge’s ISO Class 5 environment, compliant with USP standards and produced according to CGMP. The product only requires dilution, thus eliminating the need for nonsterile to sterile compounding.

Nonsterile to sterile compounding is considered a difficult and high-risk procedure, according to the U.S. Pharmacopeial Convention. Pharmacists compounding sterile preparations are required to follow state and FDA regulations, and new USP 797 standards. In a preface to the new regulations, the USP cautions: “Understanding the risks inherent in sterile compounding and incorporating established standards are essential for patient safety. Compounded medications made without the guidance of standards may be sub-potent, super potent, or contaminated, exposing patients to significant risk of adverse events or even death.”

The use of alum irrigation was first introduced in 1982 in the Journal of Urology, and intravesical alum therapy has been used widely since. An ongoing issue for physicians wanting to provide this treatment for patients is the difficulty of obtaining the sterile preparation of alum that is required for intravesical administration/instillation.

The burden of nonsterile to sterile compounding and the risk of contamination affecting patient safety has understandably led some hospital pharmacies to discontinue compounding various medicines, including alum. Edge Pharma’s sterile concentrated alum solution makes it possible for physicians to continue providing this vital treatment.