Drugmakers, pharmacists and others are calling for flexibility in the US Food and Drug Administration’s (FDA) proposed rule on requirements for nonprescription drug products with an additional condition for nonprescription use (ACNU), including how an ACNU is deemed necessary.
The proposed rule, which was issued in June 2022, outlined additional application, labeling and postmarketing reporting requirements for nonprescription drugs with an ACNU. FDA has said the proposal is aimed at improving access to nonprescription drug products in cases where labeling alone is not enough to ensure appropriate self-selection and use by consumers (RELATED: FDA proposes rule broadening nonprescription drug access for consumers, Regulatory Focus 28 June 2022)…
