Beyond the Label: Will FDA’s ACNU Framework Transform Nonprescription Access?
Imagine walking into your local pharmacy without a prescription and purchasing a medication that traditionally required one after completing a questionnaire or similar screening process. Medications that previously depended on practitioner involvement could become more accessible if consumers successfully complete safeguards approved by the Food and Drug Administration (FDA). That possibility is at the center of FDA’s Additional Condition for Nonprescription Use (ACNU) framework.
The FDA issued the final ACNU rule in December 2024. After two delays, the rule took effect on May 27, 2025. The framework establishes a pathway for approval of a nonprescription drug when product labeling alone would be insufficient to ensure appropriate self-selection, actual use, or both without the supervision of a healthcare practitioner.
ACNU also arrives during a period of broader changes in FDA policy. As discussed in other recent BLS articles, the FDA has updated its approach to certain low-risk digital health products and clinical decision support software, proposed an evidentiary framework for certain individualized rare-disease therapies, and revisited its treatment of some unapproved injectable peptides. These initiatives arise under different legal authorities and address different products, but each reflects continued attention to how regulatory safeguards should operate as science, technology, and consumer access evolve.
The ACNU framework may expand access to some medications that historically could not satisfy the labeling-only standard for nonprescription use. But the path from prescription-only status to the retail shelf is not necessarily a simple one. The framework creates regulatory, operational, and liability considerations for manufacturers and other parties involved in making those products available.
Expanding the Nonprescription Framework
Nonprescription drugs traditionally must include labeling that allows consumers to determine whether a product is right for them and how to use it safely and effectively without the supervision of a healthcare practitioner. That standard works for many familiar over-the-counter products. But it may be more difficult to satisfy when important information cannot be communicated adequately through labeling alone.
The ACNU framework offers another option, potentially opening a door to nonprescription access for qualifying products. Under the rule, an applicant may propose an additional condition that, if approved by the FDA, the applicant would implement to ensure appropriate self-selection, actual use, or both.
Appropriate self-selection concerns whether a consumer can determine that the drug is suitable based on factors such as medical history, symptoms, contraindications, or other medications. Appropriate actual use concerns whether the consumer can use the drug properly after selecting it.
The FDA has identified a questionnaire as one possible ACNU. For example, a screening tool might ask about medical history, contraindications, or other medications to determine whether the consumer satisfies the criteria for purchasing or using the product. However, the rule does not prescribe a particular technological or operational model, and the additional condition will depend on the product for which approval is sought.
An applicant seeking approval of a nonprescription drug with an ACNU must:
- explain why the ACNU is necessary;
- identify what the consumer must do to satisfy it;
- describe how successful completion will be determined;
- provide evidence that the condition supports appropriate selection or use; and
- explain how the ACNU will operate in practice.
When a prescription drug is already approved, the manufacturer must submit a separate application for initial approval of a nonprescription version with an ACNU. Approval cannot be obtained through a supplement to the existing prescription drug application. The rule permits the prescription and nonprescription versions to be marketed simultaneously, with the ACNU itself serving as a meaningful difference between the products.
Notably, the framework does not create an expedited review program. It creates a new regulatory option, but not necessarily a simple one.
The Promise of Broader Access
The FDA has stated that the rule is intended to increase options for consumer access to appropriate, safe, and effective nonprescription products, including some medications used to treat chronic diseases or conditions.
A nonprescription option could allow some consumers to obtain medication without first arranging for a healthcare appointment and obtaining a prescription from a healthcare practitioner. For qualifying products and consumers, that could provide greater control over routine healthcare decisions and reduce barriers created by geography, scheduling, or transportation.
Simultaneous availability of prescription and nonprescription versions could also provide flexibility. Some consumers may continue to obtain medication through a healthcare practitioner, while others may use the ACNU process. The appropriate channel may depend on the consumer, the product, applicable insurance coverage, and the need for clinical support.
However, potential benefits should not be overstated. Removing the prescription requirement does not necessarily make a product affordable, accessible, or appropriate for every consumer. A screening process may also direct some consumers to consult a healthcare practitioner rather than permit them to obtain the product. That result would not necessarily represent a failure. It may instead demonstrate that the ACNU is performing its intended evaluative function.
From Regulatory Approval to Real-World Use
Obtaining approval is only one part of the challenge. An ACNU is not merely an educational tool offered alongside a medication. Its approved elements and operation become part of the product’s regulatory requirements.
A non-prescription drug with an ACNU must carry a statement alerting consumers to the additional condition. The statement must appear in specified locations in bold, black type within a yellow background banner and must satisfy applicable font-size requirements.
Implementation may prove more complex than labeling. If an ACNU operates through an electronic questionnaire or another digital process, its performance may depend on software, communications networks, consumer interfaces, and outside service providers. In that setting, the technology-enabled safeguard becomes part of the product-access process, and its failure may have both regulatory and practical consequences. An outage or technical error could prevent consumers from completing the required condition or could incorrectly permit or deny access.
The process will also need to function effectively for its expected users. Accessibility, language, health literacy, and clarity may affect whether consumers understand the questions and provide meaningful responses. If the ACNU collects personal or health-related information, privacy and cybersecurity considerations may arise as well.
Manufacturers may rely on retailers, software developers, or platform operators to perform elements of the process, while remaining responsible for implementing the ACNU in accordance with the approved application. Agreements with those parties may need to address performance standards, system changes, incident response, regulatory cooperation, insurance, and allocation of financial responsibility.
Failures can have regulatory consequences. A product may be misbranded if its ACNU is not implemented in accordance with the key elements or operationalization approved by the FDA. The rule establishes postmarket reporting obligations for certain ACNU failures.
Emerging Liability Considerations
The shift from practitioner-mediated prescribing to consumer self-selection may also reshape the liability analysis. ACNU products could raise new questions about the application of traditional product liability principles.
Manufacturers of prescription drugs have historically directed warnings to prescribing healthcare practitioners, subject to jurisdiction-specific principles that may include the learned-intermediary doctrine. When a consumer obtains an ACNU product without a prescriber, the manufacturer’s consumer-facing warnings and the ACNU process itself may assume greater importance. In a resulting claim, a court may focus more directly on labeling, the design and operation of the additional condition, and information presented to consumers.
The availability of learned-intermediary principles will depend on the jurisdiction, the role of any pharmacist or other healthcare professional, and the particular allegations. It should not be assumed that the doctrine either applies or disappears in every ACNU case.
Potential claims could also focus on whether the ACNU asked appropriate questions, applied its qualification criteria correctly, functioned reliably, or provided understandable instructions. Depending on their roles, retailers and technology providers could become involved in those claims. That prospect may also raise indemnification and coverage questions among manufacturers, retailers, technology providers, and other businesses participating in the ACNU process.
Federal preemption may present further uncertainty. The analysis could depend on what the FDA specifically approved, the nature of the state-law duty asserted, and whether the manufacturer could independently make the change allegedly required. A challenge to an FDA-approved element may raise different issues from an allegation that the manufacturer failed to operate the ACNU as approved.
For manufacturers and insurers, these uncertainties make the division of responsibility particularly important. Before an ACNU product reaches consumers, the participating businesses should understand who controls each component, how failures will be identified and reported, and how contracts and insurance address losses involving the drug, supporting technology, consumer data, and third-party services.
Looking Ahead
The practical significance of ACNU will become clearer as the FDA reviews applications and products enter the market. As of the publication of this article, the FDA’s public ACNU webpage does not identify an approved nonprescription drug using the framework. The first approvals may begin to test whether ACNU can operate as a practical route to broader access or will prove useful only for a limited group of products. They may also reveal what evidence the FDA expects and how manufacturers address implementation across retail and online channels.
Whether ACNU becomes a transformational pathway or remains a niche regulatory mechanism will depend on how successfully manufacturers, retailers, regulators, and consumers navigate these new responsibilities. The framework has the potential to expand access, but its success will ultimately be measured by whether it does so while supporting appropriate product selection and use. For manufacturers, service providers, and insurers, the operation of the additional condition may prove as significant as the medication itself.
Authored by Phillip Skaggs, J.D., Berkley Life Sciences, Vice President, Chief Legal and Regulatory Affairs Officer
This post is for general informational purposes only and is not intended as legal or other professional advice.