DOL-Labor Department

Why This Course is Important
Without this course, your organization risks non-compliance with upcoming FDA requirements, leading to potential product misbranding, regulatory delays, and restricted access to the U.S. drug market.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments.

Key regulatory references include:

• 21 CFR Part 207 – Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code

Course SKU
FR-26-2077-1