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Ophthalmic Drug Dispensers Being Reclassified In US As Combo Products Get Regulatory Leeway

 
• By Brenda Sandburg

US FDA gives 12 month grace period for ophthalmic products once regulated as drugs to comply with requirements for combination products and temporarily exempts lower-risk constituents. Guidance specifies changes agency is making in response to Genus Medical v. FDA decision.

Eye dropper
• Source: Alamy

The US Food and Drug Administration is giving manufacturers of Rx and OTC ophthalmic drug dispensers 12 months to meet regulatory requirements for combination products.

The agency has regulated eye cups, eye droppers, and other dispensers for ophthalmic use as drugs when they are packaged together with ophthalmic drugs with which they are intended to be used

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