Fagron reshapes the U.S. Sterile Compounding Industry

Mon, 07/13/2015
Fagron North America will open one of the largest 503B human drug outsourcing facilities in the U.S. in November utilizing automation not yet seen in the worldwide sterile compounding industry.
Operating as Fagron Sterile Services, the new 50,000-square-foot facility in Wichita, Kansas, will feature a 12,000-square-foot clean room, automated pharmaceutical compounding systems, and expanded product offerings. The new facility, located near JCB Laboratories’ current facility, represents the largest capital investment that Fagron has made in its 25 years in business.
“Our ultimate vision is to be the model for safe, high-quality sterile compounding in North America,” said Brian Williamson, PharmD, former president of JCB Laboratories and the new president of Fagron Sterile Services. “Our goal is to work with the FDA so that our facility might serve as a training site for FDA inspectors and inspectors for other regulatory bodies. Fagron aims to work collaboratively with the FDA and to set the standard for the rest of the industry.”
The Wichita expansion by Fagron will bring new scalability to the U.S. that will ensure the availability of more sterile products, which has long been a concern for providers, pharmacists and patients.
“For so many years, the use of automated equipment made sterile compounding facilities look like manufacturers. Now, with the Drug Quality and Security Act (DQSA) in place and outsourcing facility registration with the FDA, if you don’t have automation, you’re out. Sterile manufacturers have proven that automated production equipment is the safest, most reliable way to get products to patients,” Williamson said. “With Fagron, we’re building it now. Bigger. Faster. Stronger. It’s all coming together.”
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