Webinar Review: FDA’s Verification System Draft Guidance for Pharmaceutical Industry

July 27, 2022

Greater Clarity of Product Verification Requirement  

Published in March 2022, the Verification System Under the DSCSA Draft Guidance for the Industry provided greater clarity to the public of the existing DSCSA tracing and verification requirements.  This is the 4th guidance documents published by the FDA regarding product verification. This guidance document further explains the concept of possession, control, physical custody, ownership and of which a product is verified. It also explains the difference between verification of a suspect product versus a saleable returned product.  LSPediA hosted an educational webinar on July 14th that was well attended by manufacturers, wholesalers, and dispensers.  

Multiple Scenarios Two Methods

Speaker Jami Vincent, Sr. Director of Quality, dissected the guidance requirement into Suspect Product Verification and Saleable Returns Verification. She shared a recent case where more than $250 million of counterfeit versions of two blockbuster products were sold in the US over the last two years. Such a case underscores the importance of product verification implementation, what to look for with suspicious products, and how to track potential sources of these products.

Attendees also learned two methods of verification, Direct to Repository (for example, verify within internal EPCIS) and Direct to Source (for example, verify via VRS). These two methods complement each other but do not replace each other. The former is widely used for saleable returns verification in addition to VRS. The latter, a must have for suspect product verification as a strong defense against counterfeiters. Jami walked through the decision tree of selecting the right verification method based on how the product is acquired and other dependencies. To illustrate this complex concept, Jami provided detailed infographics and workflows customized for each trading partner type to punctuate the most important messages.  

Register for the September FDA Guidance Webinar

Did you miss Jami’s insights? Not to worry, we’re hosting another event on September 13th 2022 where she will not only cover FDA Guidance on Verification Systems Under the DSCSA, but she will also cover FDA’s Authorized Trading Partner guidance including licensure and reporting as well as Interoperable Exchange of Information guidance. Even if you attended her presentation on July 14th, this event is sure to cover new material that is important for everyone impacted by the upcoming DSCSA deadline. Space is limited, register today.