FDA Proposes Benefit-Risk Assessment Guidance for New Drug and Biological Products - Celegence

Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products: FDA Guidance Explained


In the realm of nonprescription drug products, even minor labeling changes require careful consideration and documentation to ensure regulatory compliance and consumer safety. The Food and Drug Administration (FDA) has released comprehensive guidance to assist applicants of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in navigating the process of documenting such changes in annual reports. Let’s delve into the key aspects outlined in this guidance. The guidance is aimed at applicants of approved NDAs and ANDAs, helping ensure that consumers have timely access to the most current labeling information for the safe and effective use of nonprescription drug products.

The FDA is accepting comments on the draft guidance until 13 May 2024. Stakeholders are encouraged to review the document and submit their comments by this date. For those who cannot submit comments online, there is an option to mail written comments to the specified docket number: FDA-2023-D-5616. The guidance is currently in draft form and is being distributed for comment purposes only. It contains non-binding recommendations and is not yet implemented.

Understanding the Draft Guidance

The draft guidance, titled “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products,” provides recommendations for applicants of approved NDAs and ANDAs on documenting minor labeling changes in their next annual report. It aims to clarify what constitutes minor changes and how to document them in accordance with FDA regulations.

Importance of Minor Labeling Changes

Minor errors or updates in labeling may seem inconsequential, but in the highly regulated landscape of nonprescription drug products, even small modifications can have implications for consumer safety and product effectiveness.

These minor changes can be implemented immediately by the applicant without submitting a supplement to the FDA. However, the applicant must document these minor changes, including minor labeling changes, in their next annual report.

The annual report should include a summary of all changes in labeling, including minor changes, made since the last report, listed chronologically by date of implementation, or a statement indicating no changes have been made.

The FDA’s guidance aims to provide clarity on what constitutes minor changes and how to document them appropriately.

Examples of Editorial or Similar Minor Labeling Changes

  • Editorial: Correcting misspellings, punctuation, or grammar.
  • Packaging Information: Updating manufacturer, packer, or distributor information. Modifying packaging elements (eg: NDC numbers, UPCs, or graphics).
  • Artwork: Adjusting design or color schemes of package labels. Relocating logos or graphics while ensuring readability is maintained.

Additional Considerations

  1. Changes to Drugs Fact Label (DFL):
    • Typically, alterations to the content within the DFL are not considered minor changes and cannot be documented in an annual report.
    • However, specific changes to the DFL, such as color adjustments or relocating the tamper-evident statement, may qualify as minor changes.
  2. Impact of Multiple Minor Changes:
    • Implementation of multiple minor changes collectively could potentially affect consumers’ understanding of essential labeling information.
    • In such cases, applicants should opt to submit a supplemental application rather than relying solely on an annual report.
    • FDA may request a supplemental NDA or ANDA if an applicant includes multiple changes in their annual report, particularly if the alterations significantly alter the appearance of the product packaging.

Engagement and Feedback

The FDA encourages stakeholders to actively engage with the guidance and provide feedback within the specified timeframe. This collaborative approach ensures that the guidance remains relevant and effective in addressing the evolving needs of the industry.


Navigating minor labeling changes for nonprescription drug products requires attention-to- detail and adherence to regulatory guidelines. By following the FDA’s comprehensive guidance, applicants can streamline the documentation process while maintaining compliance and ensuring consumer safety. Stay informed, stay compliant, and contribute to shaping the future of nonprescription drug product regulation.

Download the FDA draft guidance document – “Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products: FDA Guidance” here.

Starting your journey towards meeting with the FDA regulatory requirements? Let Celegence assist you. Reach out to us today to explore the possibilities of partnering with Celegence’s regulatory team. For more information reach out to us at info@celegence.com, contact us online or learn more about our service offering on our services page.