EXPERTS IN STERILE PHARMACEUTICAL SOLUTIONS
503B HUMAN DRUG OUTSOURCING
|Providing high-quality sterile preparations that are produced with industry-leading automation and quality control systems.|
MIAMI – Fagron North America, a leading supplier of compounded medications to hospital pharmacies and patients, will open one of the largest 503B human drug outsourcing facilities in the U.S. in November utilizing automation not yet seen in the nation’s 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.”
Before being acquired by Fagron in December 2013, JCB Laboratories ranked as one of the nation’s top sterile compounding companies. Pharmaceutical compounding is an essential part of health care that enables prescribers and pharmacists to fulfill the worldwide growing need for tailor-made medication and for the production of drugs that are commercially unavailable.
JCB Laboratories is known for the investments it has made in its sterile facilities, as well as the reliability of its product quality and delivery. The acquisition by Fagron began in 2013 when Williamson was working with legislators in Washington, D.C., on new legislation to regulate sterile compounding.
“We wanted to know how Europe had handled similar situations,” Williamson said. “A colleague introduced us to Fagron. They came to Wichita the next day and saw our facility. By the time they left, I had an invitation to go to Europe to see how Fagron operates.”
JCB Laboratories, founded in 2002, was not new to the idea of being acquired. “We had a strategic buyer and investment groups looking at us already,” Williamson said. “At the same time we were looking to redefine the standards for sterile compounding, Fagron was also looking for an established category leader to be its platform for growth in the U.S.”
JCB Laboratories will operate under Fagron’s new divisional structure, though Fagron will rely on JCB Laboratories’ proven method of sterile compounding and reliable product delivery.
“We immediately saw a U.S. company that could be the vanguard for our U.S. expansion in sterile compounding,” said Jake Jackson, Fagron North America President. “JCB Laboratories has been a company of vision with a culture of constant improvement and the proven ability to execute. What they needed was the product development and capital resources a global company like ours provides.”
Williamson said he was excited about Fagron’s aligned values, trust and cultural fit. “Fagron is a youthful, entrepreneurial, R&D company with the vision and resources to seriously reshape and redefine the sterile industry in the U.S. and globally,” said Williamson.
The Wichita expansion by Fagron will increase the size of JCB Laboratories’ current facilities by six times. This 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. It was certainly frowned upon. 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.”
Fagron North America is a group of innovative, scientific pharmaceutical companies that focus on optimizing and innovating pharmaceutical compounding across the U.S. Fagron North America is a leading supplier of pharmaceutical raw materials, equipment and supplies, concepts and compounded medications to hospital pharmacies and patients. Fagron North America is fully integrated with significant capabilities in research, development, manufacturing and distribution. Fagron North America is headquartered in Miami, Florida.