This course provides an in-depth look at the FDA’s final rule for nonprescription drugs that have an Additional Condition for Nonprescription Use (ACNU). Participants will learn about the critical application, labeling, and postmarketing requirements. The course also explains the reasons behind the delayed implementation date and how this impacts stakeholders.
In this course you will learn the following:
* Understand the purpose and scope of the final rule on nonprescription drug products with an ACNU.
* Identify the key requirements for applications, labeling, and postmarketing reporting.
* Recognize the implications of the delayed effective date and the reasons for the delay.