Airplan develops ready-made clean room in compliance with current standards

摘要

Late last year, the US experienced a fungal meningitis outbreak rated as epidemic that spread across 20 states. It was caused by contaminated epidural steroid injections prepared in a drug compounding pharmacy in Massachusetts. As Florida was one of the most affected states, its Department of Health (DOH) and Board of Pharmacy recently approved draft legislation that regulates the preparation of drug formulations, parenterals and mixtures in compounding pharmacies. One of the key aspects addressed by this amendment is where and under what specific conditions compounding centres will be allowed to prepare parenteral injections or mixtures and which regulations must be complied with by the facilities destined to be used for compounding purposes as well as during the compounding process itself.