Outsourcing Facilities Face Rising Drug Compounding Risks

Law360 (September 18, 2019, 5:42 PM EDT) -- In recent years, the drug compounding industry has expanded significantly, with an estimated U.S. market size of $8.9 billion in 2019 and annualized market size growth of 2.3% over the last five years.[1]

Part of this expansion can be attributed to the Drug Quality and Security Act, which Congress enacted in 2013 following a fungal meningitis outbreak caused by contaminated drugs compounded by the New England Compounding Center. The DQSA addressed certain ambiguities in existing law by creating a new category of compounder — an outsourcing facility — permitted to engage in non-patient-specific compounding if certain statutory conditions are met....

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