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  4. Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use - 02/01/2023
  1. News & Events for Human Drugs


Event Title
Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
February 1, 2023

February 1, 2023
1:00 PM - 2:00 PM ET

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FDA will provide an overview of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an additional condition for nonprescription use (ACNU). The proposed rule is intended to increase options for the development and marketing of safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers.

Participants will gain a general understanding of the proposed rule and the proposed requirements for a nonprescription drug product with an ACNU.


  • Overview of how nonprescription drugs are marketed and regulated in the U.S.
  • Labeling for nonprescription drugs and its limitations
  • Overview of FDA’s proposed requirements for nonprescription drug products with an ACNU


  • Discuss the two classes of drugs in the U.S. and where nonprescription drug products with an ACNU fit in
  • Explain why labeling is so important for nonprescription drug products
  • Discuss the limitations of labeling for nonprescription drug products
  • Explain the proposed requirements in FDA’s proposed rule for a nonprescription drug product with an ACNU


  • Regulatory science and regulatory affairs professionals involved in the development or marketing of nonprescription drugs (NDAs and ANDAs).
  • Consultants focused on developing or marketing nonprescription drug products


Elisabeth Walther, PharmD, JD
Associate Director for Strategic Initiatives
Office of Nonprescription Drugs (ONPD) | CDER | FDA



This webinar has been approved for 1.00 contact hour of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. After the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim codes.

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This webinar has been:

  • pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration
  • approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.


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