Monday, April 22, 2013

Following mold scare, Tinton Falls drug compounding center must comply with new regulations


 
A Tinton Falls drug compounding business that has been closed since mold was discovered in five infusion bags sent to a Connecticut hospital must prove it can meet enhanced safety standards before being allowed to reopen, state regulators said.
Med Prep Consulting Inc. halted operation in mid-March afterrecalling its entire line of drugs when contaminated bags of magnesium sulfate it had compounded and dispensed to Yale-New Haven Hospital were found. No injuries were reported but state and federal regulators, and the company, launched an investigation.
Med Prep attorney Angelo Cifaldi said the company will submit a report Wednesday that shows it is complying with state Board of Pharmacy prescribed improvements. Those heightened standards include limiting the number of employees allowed in a “clean room,” along with increasing requirements for employee clothing cover and placing more emphasis on instrument sterility.
In an interview Monday, Cifaldi said Med Prep could be allowed to reopen on Thursday or more likely early next week.
But state Department of Consumer Affairs spokesman Neal Buccino would not provide a date.

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