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US FDA Doesn’t Budge On ‘ACNU’ Switch Requirements Questioned By OTC Industry

 
• By Malcolm Spicer

Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.

(Source: Shutterstock/Citeline)

The US final rule for OTC switches available under “additional conditions for nonprescription use” taking effect on 27 January differs little from the proposed rule the Food and Drug Administration published more than two years ago other than insignificant textual changes to further clarify or explain the agency’s stated intent.

That’s not to say moving the agency’s proposal for targeting making more formulations available nonprescription through “novel switches” didn’t go through changes on its path from idea to proposed rule...

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