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  6. Regulatory Framework for Human Drug Compounding
  1. FDA Pharmacy Student Experiential Program

Regulatory Framework for Human Drug Compounding

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

On Tuesday, September 26, 2023, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: Regulatory Framework for Human Drug Compounding. Compounded drugs serve an important medical need for certain populations who cannot be treated with FDA-approved medications, including pediatric patients or patients with allergies requiring drugs made without certain excipients. Although compounded drugs can serve an important medical need for certain patients, they also present a risk. FDA's compounding program aims to protect patients from unsafe, ineffective, and poor-quality compounded drugs, while preserving access to drugs compounded pursuant to provisions established in the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning Human Drug Compounding. This presentation provided an overview of human drug compounding and its regulatory framework, differentiated drug compounding from the FDA new drug approval process, described the bulk drug substance evaluation process, and provided examples.

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

  1. Navigate to 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 “Enduring Materials” 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, learners may view or print their statement of credit.

For those of you who are pharmacists or pharmacy technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy—otherwise known as “NABP”—provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor.  If you do not see your credit reflected on the CPE Monitor after 45 days after completion of the activity, please contact FDACETeam@fda.hhs.gov. The CPE Monitor sets a strict 60-day limit on uploading credits.

Initial release date: November 15, 2023
Expiration date: November 14, 2026

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