The US FDA maintained its stance on 'ACNU' switch requirements, despite OTC industry concerns. The proposal to make more formulations available nonprescription through 'novel switches' evolved from a 2012 idea to a final rule in December 2022.
The FDA finalizes a rule for nonprescription drugs with an Additional Condition for Nonprescription Use (ACNU), allowing marketing without a prescription if an additional condition ensures safe and effective consumer use. This aims to expand safe, effective nonprescription drug options and improve public health by increasing consumer access.