The FDA DOES NOT RECOMMEND DELAYING compliance with DSCSA requirements for product-level serialization. The 08/30/23 announcement states that the FDA is providing a “Stabilization Period” before it will enforce the Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies. Reference the Guidance Document DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs.
IPC has partnered with industry leaders PRS and Advasur to provide you with IPC SecureLink to provide our GPO members with the most straightforward solution for meeting the requirements for DSCSA now. Complete the form above to get started. If you have additional questions about SecureLink, please email [email protected].