What is ACNU?
ACNU stands for “Additional Condition for Nonprescription Use,” a regulatory framework introduced by the U.S. Food and Drug Administration (FDA) to make certain medications available over-the-counter (OTC) while ensuring they are safe and effective for consumer use without a healthcare provider’s direct supervision.
What is the Final Rule on Nonprescription Drug Products with an Additional Condition for Nonprescription Use?
The FDA issued the Final Rule on Nonprescription Drug Products with an Additional Condition for Nonprescription Use to create a structured pathway for medications that require consumers to complete an additional step—beyond reading a drug label—before determining whether a drug is appropriate for them.
These additional steps might include:
- Answering a digital questionnaire
- Using an interactive tool
- Completing an in-store checklist
The ACNU framework aims to expand access to medications that would otherwise remain prescription-only while ensuring consumers can safely and effectively self-select and use these products.
Why Did the FDA Introduce ACNU?
In the past, some medications could not become OTC. This was because consumers might not understand the labeling information well enough to make good choices. The ACNU rule addresses this gap by allowing manufacturers to implement additional tools or conditions to guide consumers safely.
What Does ACNU Mean for Consumers and Manufacturers?
- For Consumers: Easier access to medications for chronic disease management or preventative care without needing a prescription.
- For Manufacturers: A clear regulatory pathway to demonstrate that self-selection tools and labeling meet safety and usability requirements.
The Opportunity Ahead
The ACNU framework represents a significant step towards healthcare accessibility and innovation. By ensuring clear, user-friendly tools and effective labeling, the FDA enables moThis includes doing label comprehension, self-selection, actual use, and human factors studies. These studies help support the approval of nonprescription drugs under the ACNU framework.re consumers to make informed health decisions confidently.
ACNU gives manufacturers a chance to sell important medications over the counter. They can do this while keeping safety and usability high.
Confidently Navigate ACNU Compliance with SoundRocket
Navigating the complexities of ACNU requirements doesn’t have to be overwhelming.
At SoundRocket, we specialize in supporting manufacturers through the ACNU approval process with expertise in Tool Design & Validation, Label Comprehension & Self-Selection Studies and Human Factors Research.