ACNU, or Additional Condition for Nonprescription Use, is a regulatory framework established by the FDA that allows certain prescription drugs to transition to nonprescription status provided that an additional condition is implemented to ensure appropriate self-selection or actual use by consumers without the supervision of a healthcare provider.

Traditional OTC drugs rely solely on labeling for safe and effective use. ACNU products include an additional condition, such as a questionnaire or app, to guide consumers in determining whether the drug is appropriate for them or how to use it safely.

The ACNU framework was developed to expand consumer access to safe and effective medications while addressing limitations of labeling alone, especially for drugs requiring more complex self-selection or usage criteria.

Examples of ACNU implementations include: Self-Selection Software: Consumer qualification software that guides individuals through a series of tailored questions to determine their eligibility for a medication, ensuring accurate self-selection, appropriate use, or both. Phone-Based Systems: A toll-free phone system that consumers can call to complete an automated or guided eligibility assessment and receive instructions for safe usage. In-Store Kiosks: Physical kiosks in retail or pharmacy locations that provide interactive tools for consumers to assess their eligibility and receive guidance on appropriate medication use.

ACNU has a transformative impact on multiple stakeholders, driving greater accessibility, innovation, and public health benefits: Consumers: ACNU empowers individuals to take control of their health by providing easy access to medications without a prescription. It reduces barriers such as cost, time, and the need for in-person visits, while also maintaining privacy for those managing sensitive conditions. Pharmaceutical Companies: The ACNU pathway opens new market opportunities by transitioning prescription medications to nonprescription status. It fosters innovation, allowing companies to differentiate their brands with consumer-focused solutions that build trust and loyalty. Public Health: By broadening access to self-care options, ACNU reduces the strain on healthcare systems and promotes early intervention for common conditions. It also enhances medication adherence, improves overall health outcomes, and addresses disparities by reaching underserved populations. Healthcare Systems: ACNU allows healthcare providers to allocate their time and resources to more critical cases. This shift reduces unnecessary visits and improves the efficiency of healthcare delivery, particularly in overburdened systems.