Nonprescription Drug Product With an Additional Condition for Nonprescription Use

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The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The proposed rule is intended to increase options for applicants to develop and market safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.