FDA’s Proposed Rule on Compounded Drug Challenges

Explore the FDA’s proposed criteria for determining which drug products present significant challenges for compounding. Understand the implications of being listed on the Demonstrable Difficulties for Compounding Lists (DDC Lists) under the Federal Food, Drug, and Cosmetic Act. This course provides insights into the legal framework, the proposed drug categories, and the role of public participation in shaping the final rule.

In this course you will learn the following:
* Comprehend the purpose and intent of the proposed rule.
* Recognize the importance of public participation and how to submit comments.
* Understand the potential changes and the non-final nature of the rule.