U.S. Food & Drug Administration

Description

This webinar discussed the different types of FDA-approved prescription drug labeling including carton and container labeling, patient-labeling (Medication Guides, Patient Package Inserts, and Instructions for Use), and the Prescribing Information; described the process for approval of the Prescribing Information; explained some key parts of the Prescribing Information; and discussed the similarities and allowable differences between generic drug labeling and labeling for a previously approved drug with the same active moiety or reference listed drug.

References

Prescription Drug Labeling Resources at https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources
Guidance for industry: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements (February 2013) at https://www.fda.gov/media/71836/download
Guidance for industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products – Content and Format (October 2011) at https://www.fda.gov/media/71866/download
Guidance for industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (March 2010) at https://www.fda.gov/media/72142/download

Learning Objectives

Identify the different types of FDA-approved prescription drug labeling
Discuss the process for FDA approval of prescription drug labeling
Describe the contents of selected parts of the Prescribing Information
Explain the differences between generic drug labeling and reference listed drug labeling

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health Professionals (CPH), 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 JA0002895-0000-22-029-H04-P, and ACPE Universal Activity Number JA0002895-0000-22-029-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

This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria.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

Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - 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
March 4, 2022

Expiration Date
December 31, 2024

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