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ACNU: Charting The Future of Rx-to-OTC Transitions.

What is an ACNU?

An ACNU, or Additional Condition for Nonprescription Use, is a proposed rule introduced by the FDA to broaden the range of nonprescription drugs. This rule allows qualified prescription drugs to switch to nonprescription if additional conditions are met to ensure their safe and effective use without a healthcare provider's supervision.


This initiative provides pharmaceutical companies with an opportunity to extend the marketability of established drugs and to consider nonprescription options for drugs that previously could not be switched based on labeling alone.

Renew Brands.

Breathe new life into established brands and achieve Rx-to-OTC switches that couldn’t be accomplished with labeling alone.

Expand Reach.

Expands access and facilitates personal health management through simplicity, convenience and privacy.

Harness Data. 

Detailed postmaketing data to meet FDA requirements and build richer consumer relationships with tailored support.

Transform Public Health.

Align with the trend of self-care to support personalized healthcare and bolster public health initiatives.

Leaders in ACNU Designation and Self-Selection Technology.




Proprietary digital care platform specifically designed for ACNU qualification algorithms, reporting, and reassessment.

  • Proven FDA Compliance.

  • Reduces time and cost.

  • Integrates with any interface.

  • Integrates with any fulfillment service.

  • Cloud framework with ML capabilities

  • Robust cybersecurity & risk monitoring

  • Postmarketing surveillance



Predicting ACNU Potential in Rx drugs.

Effectively utilizing DS/ML/AI to leverage real-world data in forecasting the potential for ACNU designation in Rx drugs.



Expertise in ACNU, Clinical Compliance.

Regulatory team that specializes in ACNU guidance, clinical studies and technical compliance challenges.


Launch Partner

Guiding from Inception to Product-Market Fit.

Specializing in RTO portfolio assessments, digital clinical trial recruiting and digital marketing solutions for commercial launch.

Our ACNU Journey.

For over seven years, we've been deeply involved in ACNU programs, consistently pushing boundaries and advocating for more accessible medication options. A testament to our commitment and expertise is our recent milestone: successful completion of our program's first Actual Use Study.

Currently, we have five ACNU projects in our development pipeline, reflecting our active role in this transformative space. We take pride in our impressive success rates: a 96% self-selection success and a 97% human factors success. These figures not only showcase our capability but also our dedication to quality and safety in the pharmaceutical landscape.

Empower Self-Care, Increase Consumer Access, and Tap into Expanded Marketing with ACNU.


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