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    Additional Condition for Nonprescription Use

    FDA framework for nonprescription drugs with approved additional conditions needed for appropriate self-selection or actual use when labeling alone is insufficient.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

    Definition

    An ACNU is one or more FDA-approved conditions an applicant must implement to ensure appropriate self-selection or actual use, or both, without supervision of a licensed practitioner, when labeling alone is insufficient. The final rule became effective May 27, 2025. Key provisions are 21 CFR 314.56 and 201.67, with additional related drug reporting requirements. Initial approval requires a separate application, not a supplement to an existing approved application. An ACNU tool is not automatically a medical device or a combination product; assess its actual functions and intended use separately.
    What the regulation says
    An ACNU is one or more FDA-approved conditions an applicant must implement to ensure appropriate self-selection or actual use, or both, without supervision of a licensed practitioner, when labeling alone is insufficient. The final rule became effective May 27, 2025. Key provisions are 21 CFR 314.56 and 201.67, with additional related drug reporting requirements. Initial approval requires a separate application, not a supplement to an existing approved application. An ACNU tool is not automatically a medical device or a combination product; assess its actual functions and intended use separately.

    What this means in practice

    An ACNU is one or more FDA-approved conditions an applicant must implement to ensure appropriate self-selection or actual use, or both, without supervision of a licensed practitioner, when labeling alone is insufficient. The final rule became effective May 27, 2025. Key provisions are 21 CFR 314.56 and 201.67, with additional related drug reporting requirements. Initial approval requires a separate application, not a supplement to an existing approved application. An ACNU tool is not automatically a medical device or a combination product; assess its actual functions and intended use separately.

    Examples

    • Hypothetical: an FDA-approved questionnaire could determine whether a consumer can appropriately self-select a nonprescription drug. These are conceptual examples, not claims of approved ACNU products.
    Common pitfalls
    • •Do not assume an ACNU app is either marketing software or a medical device without evaluating its functions and intended use.
    • •Failing to integrate human factors testing of the ACNU early, FDA expects evidence the additional condition actually achieves safe self-selection.
    • •Ignoring post-market obligations, manufacturers must monitor whether the ACNU continues to function as intended in real-world use.

    Frequently asked questions

    An ACNU is one or more FDA-approved conditions an applicant must implement to ensure appropriate self-selection or actual use, or both, without supervision of a licensed practitioner, when labeling alone is insufficient. The final rule became effective May 27, 2025. Key provisions are 21 CFR 314.56 and 201.67, with additional related drug reporting requirements. Initial approval requires a separate application, not a supplement to an existing approved application. An ACNU tool is not automatically a medical device or a combination product; assess its actual functions and intended use separately.

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    Sources

    5 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Official-source claim check:

    ACNU is a drug approval framework effective May 27, 2025, for FDA-approved additional conditions when labeling alone is insufficient. It does not automatically create a device or combination product.

    Partial review: verified corrections are applied, but this is not a full accuracy certification. The last full review date is unchanged.

    Remaining verification limits
    • Original merged record reviewed in full. Illustrative examples are hypothetical, not verified case histories. Evidence supports the specific propositions below, not an assertion that every linked page verifies all merged content.
    Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 3
    Link health: 2 verified 3 unchecked· last checked 2026-06-20
    Federal Register·1eCFR·1European Commission·1FDA·2
    1. 1
      FDA ACNU Final Rule (Dec 2024)
      Tier 1 Verified
      Federal Registerfederalregister.gov
    2. 2
      21 CFR 201.67, ACNU labeling requirements
      Tier 1 Unchecked
      eCFRecfr.gov
    3. 3
      European Commission - Medical Devices
      Tier 2 Verified
      European Commissionhealth.ec.europa.eu
    4. 4
      FDA ACNU final rule and effective date
      Tier 2 Unchecked
      FDAfda.gov
    5. 5
      FDA seven things about ACNU
      Tier 2 Unchecked
      FDAfda.gov

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