U.S. Food & Drug Administration

Activity Outline
Enhanced Drug Distribution Security: 2023 and Beyond
February 25, 2022 - December 31, 2024

Activity Coordinators:

Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov), Thanh Nguyen-Chu (Thanh.Nguyen-Chu@fda.hhs.gov), Kara Burke (Kara.Burke@fda.hhs.gov), Lesley Navin (Lesley.Navin@fda.hhs.gov)

Description

FDA will provide updates on implementation of supply chain security requirements under the Drug Supply Chain Security Act and describe requirements that go into effect in 2023 for enhanced drug distribution security. Enhanced product tracing and verification will help protect patients by improving detection and response to suspect and illegitimate products and prevent the distribution of illegitimate products in the U.S. FDA and the supply chain will need to work together to establish a fully electronic, interoperable system for enhanced drug distribution security across the entire drug supply chain.

References

DSCSA (law) : https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/title-ii-drug-quality-and-security-act
FDA’s DSCSA webpage: https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

Learning Objectives

Summarize updates on implementation of supply chain security requirements under the Drug Supply Chain
Security Act (DSCSA).
Describe requirements that go into effect in 2023 for enhanced drug distribution security.
Explain how enhanced drug distribution security will help protect patients from exposure to drugs that may be
counterfeit, stolen, contaminated, or otherwise harmful.

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH) Professionals, and physician assistants.

Continuing Education Accreditation

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.

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 enduring material 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 JA0002895-0000-22-023-H04-P, and ACPE Universal Activity Number JA0002895-0000-22-023-H04-T for 1.00 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).

AAPA

FDA Center for Drug Evaluation and Research has been authorized by the American Academy of Physician Associates (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.00 AAPA Category 1 CME credits. Approval is valid until December 31, 2024. PAs should only claim credit commensurate with the extent of their participation.

CPH

Up to 1.00 CPH Recertification Credits may be earned at this event.

Requirements for Receiving CE Credit

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, 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, physician assistants, 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

Jung, Connie, PhD, R. Ph, Senior Advisor for Policy, FDA/CDER/Office of Compliance - nothing to disclose

Planning Committee

Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team

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.

Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
February 25, 2022

Expiration Date
December 31, 2024

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