OTC: Over the Counter, or Open to Contamination? A Review of Over-the-Counter Lubricating Eye Drops Safety.

Abstract: This review examines how gaps within the Food and Drug Administration's|Food and Drug Administration (FDA) regulatory oversight, manufacturing standards, and bottle design requirements contributed to over-the-counter (OTC) eye drop contamination and subsequent product recalls. We also discuss recent growth in the number of patients with dry eye diseases and explosion of electronic commerce (e-commerce) retailers that has created new channels for the widespread circulation of unsafe eye drops. Considering the ongoing FDA recalls, we outline actionable strategies for providers and patients and the role that advocacy organizations play in closing the gaps in OTC eye drop safety.