Abstract This article examines the US framework for pharmaceutical compounding under Secs. 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and how it interacts with pharmaceutical patent protection. It explores how, once a patented drug appears on the FDA’s shortage list, pharmacies and so-called outsourcing facilities may supply substantial market volumes with compounded versions of ‘essentially a copy’ of such drug. This article evaluates the legal implications of this regulatory gap and situates the US model within the broader international framework governing drug approval, compounding, and patent rights, and outlines potential – though politically unlikely – avenues for reform.
Peter Ganea (Tue,) studied this question.
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