Series Description

FDA's Division of Drug Information in the Center for Drug Evaluation and Research (CDER) sponsors a series of educational webinars targeting the needs of health care professionals and students. The webinars cover a broad range of FDA drug regulation and medication safety topics. These focused webinars support FDA's mission of promoting and protecting public health through interaction and education to strengthen current and future partnerships and relationships with clinicians and researchers.

Lecture Description
Drug products are colored for a variety of reason and there are different types of color additives that can be used in these products. However, all color additives must be pre-approved by the FDA and listed in Title 21 of the Code of Federal Regulations before they may be used in drugs and other FDA-regulated products. This webinar will give you an overview of FDA's regulation and enforcement of color additives in drugs, including certified and certification exempt color additives, and how the certification process works. In addition, you will learn about why color is added to drug products, the different types of color additives, the color additive petition process, and how a color additive is listed for use in drugs. Finally, we will discuss labeling requirements for color additives in drug products and how FDA enforces these regulations.

References

• Summary of Color Additives for Use in United States in Foods, Drugs, Cosmetics, and Medical Devices: http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm
• Code of Federal Regulations : eCFR :: 21 CFR Part 74 Subpart B – Drugs: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-74#subpart-B
• Color Additives: https://www.fda.gov/industry/color-additives
• Color Additive Laws, Regulations, and Guidance: https://www.fda.gov/industry/color-additives/color-additive-laws-regulations-and-guidance
• Color Additives in Specific Products: https://www.fda.gov/industry/color-additives/color-additives-specific-products
• Color Additive Science and Research: https://www.fda.gov/industry/color-additives/color-additive-science-and-research

Series Objectives

• Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.
• Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.

Learning Objectives After completion of this activity, the participant will be able to:

• Describe a color additive
• Identify certification exempt color additives and certified color additives
• Explain certification process for color additives
• Outline the color additive petition process
• Review labeling requirements
• Discuss enforcement tools

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

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

• Petigara, Bhakti, PhD, Research Chemist, FDA, Center for Food Safety and Applied Nutrition - 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

• Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Information
Registration is complimentary; therefore refunds are not applicable.