Navigating the FDA’s Final Rule on ACNU for Nonprescription Drugs

Key Areas of Focus for Manufacturers Under the New Guidelines

FDA self-selection studies are critical to the regulatory evaluation process, particularly for over-the-counter (OTC) drugs and direct-to-consumer (DTC) The FDA has recently finalized a rule about Nonprescription Drug Products with an Additional Condition for Nonprescription Use (ACNU). For answers to common questions, check out our ACNU FAQs. This marks a big change in the rules for over-the-counter (OTC) drugs. This rule opens pathways for more complex medications to become available without a prescription, provided consumers can follow additional steps to ensure safe and effective use.

For manufacturers, compliance with this rule involves demonstrating that consumers can independently understand and act on critical product information. This includes conducting label comprehension, self-selection, actual use, and human factors studies to support the approval of nonprescription drugs under the ACNU framework. Additionally, the design and effectiveness of the ACNU assessment tools—such as questionnaires or interactive digital tools—are equally critical for compliance.

In this blog post, we’ll break down the key requirements of the rule, highlight the critical studies manufacturers must undertake, and discuss how SoundRocket (SR) can support your organization in navigating these requirements effectively.

Understanding the Final Rule: Key Takeaways for Manufacturers

The primary objective of self-selection studies is to assess whether people, after reading the product label, can make a correct decision about using or The Nonprescription Drug Product with an Additional Condition for Nonprescription Use Final Rule (ACNU) introduces a structured approach for medications that require consumers to perform an additional step (e.g., completing a questionnaire or using an interactive tool) before determining whether the drug is appropriate for them​.

Key highlights of the rule include:

• Enhanced Labeling Requirements: Nonprescription drug labels must clearly communicate essential information, including the ACNU-specific step that consumers must complete​.
• Consumer Studies are Mandatory: Manufacturers must conduct robust studies to demonstrate that consumers can safely and effectively use these products without the supervision of a healthcare provider​.
• Focus on Usability: The design and delivery of ACNU tools must minimize risks associated with consumer misuse or misunderstanding​.
• Assessment Tools Are Central to ACNU Compliance: Questionnaires, digital assessments, and other interactive tools used to implement ACNU steps must be designed effectively to ensure proper self-assessment and decision-making​.

For manufacturers, this means compliance isn’t just about the drug itself—it’s also about how information is conveyed, how tools are designed, and how effectively consumers can use both.

Key Areas of Focus for ACNU Compliance

• Questionnaire and ACNU Tool Design
  The design of questionnaires and ACNU tools is a critical compliance component under the new rule. These tools must be scientifically validated and carefully crafted to guide consumers through self-selection and actual use steps. The final rule highlights the need for clarity, accuracy, and usability in ACNU tools to minimize the risk of errors and misinterpretation​.
  
• Label Comprehension Studies
  Label comprehension studies assess whether consumers can understand and correctly interpret critical information on drug labels, including ACNU-specific requirements. These studies ensure labeling effectively communicates essential information, enabling consumers to make informed decisions without professional supervision. 
  According to the final rule, applicants must include participants with varying literacy levels, reflecting national demographics, to validate label effectiveness. Moreover, the regulation stipulates that applicants need to submit a “detailed account of the precise measures a consumer should undertake or the necessary feedback a consumer must give” to comply with the ACNU, guaranteeing that tools are developed for reliable and effective compliance with labeling standards.
  
• Self-Selection Studies
  Self-selection studies evaluate whether consumers can accurately determine if a medication is appropriate for them based on the provided labeling and ACNU requirements. These studies test consumers’ ability to match their health conditions with the medication’s intended use and identify potential contraindications. Self-selection studies are especially critical when ACNU steps (e.g., digital questionnaires) guide consumers through decision points. The final rule specifies that exclusion criteria for these studies should be minimal and that an adequate representation of low-literacy consumers should be included​.
  
• Actual Use Studies
  Actual use studies simulate real-world conditions to assess whether consumers can properly adhere to all labeling instructions and ACNU requirements outside of a controlled setting. These studies aim to identify any unforeseen barriers to correct usage and confirm that ACNU tools (e.g., questionnaires or digital interfaces) perform as intended. The final rule emphasizes that actual use studies must include representative populations and test all key tasks required for proper drug use​.
  
• Human Factors Studies
  Human factors studies evaluate the design and usability of tools associated with ACNU, including questionnaires, digital interfaces, or physical aids. These studies focus on identifying and mitigating user-related hazards that may arise from design flaws or poor usability. The final rule underscores the importance of assessing the full user experience to ensure tools are intuitive and error-free, with particular attention to high-risk tasks​.
  

How SoundRocket (SR) Can Assist with ACNU Compliance

At SoundRocket, we offer specialized expertise to help manufacturers meet the requirements of the FDA’s ACNU final rule through evidence-based, regulatory-aligned strategies. Our services include:

• ACNU Tool and Questionnaire Design: With expertise in survey design and usability research, we develop scientifically validated ACNU tools—such as questionnaires and interactive digital assessments—that are intuitive and effective.
• Evaluation and Validation: Our team conducts studies to test ACNU tools under real-world conditions, ensuring they deliver reliable and actionable results.
• Design and Execution of Consumer Studies: We create and implement protocols for label comprehension, self-selection, actual use, and human factors studies to generate data that meets FDA standards.
• Regulatory Documentation and Support: We compile study results into FDA-compliant reports and assist in preparing submissions to ensure alignment with regulatory expectations.
• Iterative Refinement: Based on study findings, we guide refinements to labeling, tools, and user interfaces to address usability concerns.

Our expertise combines regulatory insight, behavioral research, and human-centered design, making us the ideal partner for navigating the ACNU landscape. Still have questions? Check out our FAQs.