The U.S. serialization compliance deadline is now just around the corner. Whether they are located in Europe, Asia, or the Americas, contract manufacturing organizations (CMOs) and pharmaceutical companies shipping prescription drugs to the United States must implement serialization programs in order to comply with FDA regulations. Since there is little time left before the law is enforced, CMOs that have not yet implemented serialization processes on their packaging lines must act quickly.
This white paper will explain why the timeline is so short for CMOs who are just starting their serialization project, and what legal and financial impacts await their business if they don’t take action soon. It will also address how to become serialization-compliant, despite the fast-approaching deadline and complex implementation steps. And finally, it will explain what to do to maximize remaining time, including the sums to invest and the steps to prioritize.