FDA Issues Draft Guidance on Verification Systems (VRS)
On October 24, 2018, FDA issued the following guidance document: Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs (Draft Guidance)
We recommend companies thoroughly review the draft guidance specific to verification systems.
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
The draft guidance document reinforces the FDAs expectations about having systems in place to manage suspect product. The document specifically references systems related to initiating and responding to requests for verification, quarantining and communicating suspect product, and saleable returns. The system functions listed are as follows:
- Systems to determine a product is suspect
- System for suspect product quarantine and investigation
- System for cleared product notification regarding suspect products
- System for illegitimate product quarantine and disposition
- System for illegitimate/high-risk of illegitimacy product notifications
- Systems for responding to requests for verification
- System for processing saleable returns
The scope of the document encompasses all supply chain participants – from manufacturers to dispensers. The FDA expects these systems and procedures to be incorporated into existing SOPs, or in new SOPs, and specifically approves the use of a secure electronic database as described in the DSCSA.
In summary, the guidance reinforces the requirements in the DSCSA and how the FDA expects trading partners to manage the verification and suspect product process.
The one new aspect the FDA highlighted was in the last sentence of the guidance in the section referencing saleable returns. The guidance states, “If the product identifier is not successfully verified, the product should be handled as a suspect product (i.e. it must be quarantined and investigated).”
This statement will no doubt come as a surprise to wholesalers and manufacturers, because it means the FDA expects a formal investigation to be initiated every time a VRS query returns a negative response to the serial number verification request. The industry estimates roughly 60 million units are processed as a saleable return annually. At these volumes, even a small fraction of negative responses will generate a huge workload for the reverse supply chain. It will be more important than ever to have a robust VRS system in place for both requestors and responders.