Course: Proposed Rule on Profits and Related Basis Adjustments based on this document from the Federal Register: https://www.govinfo.gov/content/pkg/FR-2024-12-02/pdf/2024-27227.pdf This document contains proposed regulations regarding previously taxed earnings and...
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.
Additional information
| Federal Register Title | Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. Document Number: 2024-05801 |
|---|---|
| Course SKU | FR-24-621-1 |
| Why This Course Is Important | Gain insights into the complexities and challenges of drug compounding, ensuring compliance with future FDA regulations. |