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Federal rules prompt clean-room installation in Wichita lab

  • The Wichita Eagle
  • Published Sunday, Dec. 15, 2013, at 7:27 a.m.
  • Updated Sunday, Dec. 15, 2013, at 7:32 a.m.

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JCB Laboratories, a Wichita-based compounding pharmacy, has installed a continuous clean-room monitoring system in anticipation of new federal regulations for the industry, according to a news release.

“This is just another step to show we’re invested in protecting patient safety in the products we make,” said JCB Laboratories CEO Brian Williamson. “It’s an ongoing process, investing and reinvesting in new technologies.”

Compounding pharmacies make products not available on the marketplace from manufacturers or if physicians have special orders for patients.

JCB Laboratories, which was founded in 2002, produces about 100 different products on a regular basis, Williamson said.

Compounding pharmacies operated with a low public profile until last year, when a meningitis outbreak that killed 64 people and made more than 750 people sick across the country was linked to problems at a facility in Massachusetts. The outbreak was traced to contaminated steroid pain injections produced at the now-closed pharmacy.

Under new regulations signed into law on Nov. 27, larger compounding pharmacies can choose to register with the FDA and have federal inspections, while smaller pharmacies will stay under the jurisdiction of state boards of pharmacy.

Williamson said JCB Laboratories will likely register with the FDA, but that a lot still isn’t known about how the new regulations will affect compounding pharmacies.

“The New England compounding problem was an anomaly, one of those things where a really bad company was doing really bad things. ... (But) it did raise lot of awareness of quality of compounding pharmacy,” Williamson said.

The new monitoring system, from Lighthouse Worldwide Solutions, will monitor conditions to prevent contamination before it occurs.

It continuously checks air pressure, temperature and humidity in the clean room in addition to the temperatures of drug storage areas, ovens, incubators and refrigerators. If it senses something out of the ordinary, alarms alert staff.

“Air pressure is critically important to prevent contaminants from entering the room,” Williamson said. “If there is a drop in pressure, there is a potential for contaminants and other things to come back in.”

Williamson declined to give the cost of the new system, but said it was “in the upper five figures.”

The new system is the largest of its kind installed by Lighthouse in a compounding pharmacy in the U.S., according to a news release.

The new monitoring system at JCB Laboratories is not the result of a voluntary recall of medications the company issued in August after concerns were raised about conditions at an affiliated testing lab in Loveland, Colo., Williamson said.

JCB Laboratories no longer uses the Colorado facility, Williamson said, and there were no reports of patient harm.

JCB Laboratories is licensed in 48 states and has 25 employees, Williamson said.

Contributing: Associated Press

Reach Kelsey Ryan at 316-269-6752 or kryan@wichitaeagle.com. Follow her on Twitter: @kelsey_ryan.

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