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FDA Regulation of Color Additives in Drug Products

FDA Regulation of Color Additives in Drug Products

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Tuesday, November 6, 2018, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: FDA Regulation of Color Additives in Drug Products. The U.S. Food and Drug Administration (FDA) regulates color additives under the authority of the Federal Food, Drug, and Cosmetic Act. 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 gave you an overview of FDA's regulation of color additives in drug products. You learned about the color additive petition process and how a color additive is listed for use in drugs. You also learned about the two types of color additives, certified and certification exempt, and how the certification process works. The webinar discussed the labeling requirements for color additives in drug products and how FDA enforces these regulations.

Instructions for Learners to complete home study activities, complete evaluation, and print certificate:

  1. Navigate to https://ceportal.fda.gov/
  2. If you have an account, please login
  3. If you do not have an account, click on “Create an account!”
  4. Once you’re logged in, please complete your profile if you haven't done so already 
  5. Navigate to the “Web-based Courses” tab
  6. Select the activity you want to complete
  7. Click on the “Enroll” button. As you complete all the steps listed in the box, a green checkmark will appear
  8. Begin the activity by clicking on the link at the bottom of the page
  9. After viewing the presentation, click on “Complete Post-test”
  10. After successful completion of the Post-test, click on “Complete Evaluation”
  11. After completion of the evaluation, you may view/print your statement of credit and/or certificate of completion  

Requirements for receiving CE credits:

Review the activity, complete the post-test and evaluation. Upon completion of all required steps, physicians, physician assistants, and nurses may view/print their statement of credit directly from the CE Portal.

Pharmacists and pharmacy technicians will need to provide their NABP e-profile ID number, as well as their DOB in MMDD format in their CE Portal Profile, in order to claim CE credit. Pharmacists and pharmacy technicians should log into the CPE monitor 10 weeks after the last session of the activity to obtain their CE credit.

Initial release date: June 20, 2019
Expiration date: December 31, 2019

 

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