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Latest From Joanne Eglovitch
As more highly potent and highly toxic drugs are being developed, regulators are looking into risks posed by contamination of non-contact surfaces, yet until recently, there was scant guidance on how to assess these risks.
While many in the pharmaceutical sector pay lip service to the digital industrial revolution called 4.0, few have embraced it. But that could be about to change.
A Little Rock, Arkansas, outsourcing pharmacy continued to defy FDA even after the agency went to court for an injunction to shut down the pharmacy's drug compounding operations over continued lack of sterility. Cantrell Drug Co. could have accepted proposed consent decree terms but instead countered in federal bankruptcy court with an injunction request of its own.
US FDA Commissioner Scott Gottlieb says Congress intended to preempt all state licensure laws that were not identical to federal laws for licensing wholesalers and third-party logistics providers under the Drug Supply Chain Security Act.