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Proposed OTC Switch Rule Anticipates Digital World

 
• By Malcolm Spicer

FDA’s “Additional Condition for Nonprescription Use” proposal is all about information which won’t be printed on DFLs but will be integral to whether some switch proposals’ approval. But agency doesn’t explicitly exclude switch sponsors from assigning delivery of ACNU information to staff in stores or in online chats.

• Source: Shutterstock

A proposed US rule linking information not on a Drug Facts label to an OTC switch approval not long ago would’ve had stakeholders thinking of “behind the counter” distribution with pharmacy and other retail staff advising consumers about whether they should use a certain product.

The Food and Drug Administration’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule is all...

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