Cleveland Clinic “Outsourcing”? 503B Status Would Be Milestone For US FDA’s Compounding Model
Chronic problem with drug shortages is driving the Cleveland Clinic to consider registering as a 503B “outsourcing” facility. That could be a milestone in FDA’s efforts to encourage the model for high volume compounders.
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HHS Inspector General paints a more positive picture of FDA’s efforts to bring high-volume compounding into better regulatory control than the agency’s own statements might suggest. That could mean the initiative is able to recede a bit from the top-priority status it has had at the agency for almost a decade.
Non-profit intermediary being built by hospitals and health systems offers a private sector response to one of the deterrents to adequate supplies of important older generic drugs.
FDA is planning series of stakeholder meetings to identify new approaches to drug shortages, with particular interest in defining “essential” drugs. Agency is also looking outside for expertise, with Boston University’s Rena Conti tapped as advisor.