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In Law360, Life Sciences Regulatory & Compliance Attorneys Address Drug Compounding Risks at Outsourcing Facilities

Practices: Life Sciences, FDA Regulatory, Digital Health

With the drug compounding industry expanding significantly in recent years, life sciences regulatory & compliance partner Greg Levine and associates Joshua Oyster and Rebecca Williams (all of Washington, D.C.) co-authored a Law360 article published on Sept. 18. The article provides an overview of the current state of the regulatory framework, an analysis of recent case law, and describes the implications for both drug compounders and pharmaceutical manufacturers.

The authors note that while there remain numerous legal issues to be resolved with respect to U.S. Food and Drug Administration regulation of drug compounding, FDA regulatory scrutiny of the  compounding practices of outsourcing facilities is unlikely to abate soon.

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