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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
CDER Small Business and Industry Assistance 1 Hour Web Series: Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
February 1, 2023


Activity Coordinators:
Forest Ford (Forest.Ford@fda.hhs.gov),  Brenda Stodart (Brenda.Stodart@fda.hhs.gov)
Series Description

FDA's CDER Small Business and Industry Assistance (SBIA) educational webinars target the needs of health care professionals working in the pharmaceutical industry. Subject matter experts from the FDA explain trending drug development topics, (e.g. labeling, adverse events, quality) new guidance's or regulations, and/or FDA regulatory processes. These webinars support FDA's mission of promoting and protecting public health by bridging knowledge gaps about emerging regulatory issues or areas with frequently asked questions.

Lecture Description
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.
References
  • The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/fda-announces-proposed-rule-nonprescription-drug-product-additional-condition-nonprescription-use
  • Innovative Approaches for Nonprescription Drug Products https://www.fda.gov/regulatory-information/search-fda-guidance-documents/innovative-approaches-nonprescription-drug-products
  • Nonprescription Drug Product With an Additional Condition for Nonprescription Use https://www.federalregister.gov/documents/2022/06/28/2022-13309/nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use
Series Objectives
  • Demonstrate the ability to solve FDA drug regulatory issues as they arise.
  • Explain new FDA regulatory initiatives.
Learning Objectives After completion of this activity, the participant will be able to:
  • Explain how nonprescription drugs are marketed and regulated in the U.S.
  • Discuss the labeling for nonprescription drugs and its limitations.
  • Explain the FDA’s proposed requirements for nonprescription drug products with an additional condition for nonprescription use.
Target Audience
This activity is intended for physicians, pharmacists, and nurses.
Agenda

Lecture 1 February 1, 2023
Time Topic Speaker
1:00 - 2:00 PM EST Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use Elisabeth Walther, PharmD, JD
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-008-L99-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Walther, Elisabeth, PharmD, JD, Associate Director for Strategic Initiatives, FDA CDER OND - I have the following relationship(s): Walgreen Co. - Employee: Part-time Staff Pharmacist. Paid hourly

Planning Committee
  • Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

CE Consultation and Accreditation Team
  • Henderson, Darlise, MBA, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Information
Registration is complimentary; therefore refunds are not applicable.