Managing Inventory in a DSCSA-Regulated World: Product Receipt
DSCSA introduces compliance documentation into your warehouse and with it, inventory management complications. Establishing processes to properly manage Transaction Histories, Information, and Statements (T3) is critical—if you don’t have T3 to match
What can you expect during product receipt, warehouse management, and outbound shipping, and how can you both stay in compliance and keep product flowing? In this 3-part series, let's review 7 key challenges that wholesale distributors face along with how TraceLink's Product Track can help. First up, two issues you will encounter when
1 - In mixed shipments, how can you easily identify what product must be DSCSA compliant?
You purchase a variety of products from manufacturing partners: prescription drugs that have an NDC (National Drug Code); over-the-counter medications with an NDC; and over-the-counter product with no NDC. They often arrive in the same shipment and on the same ASN (Advanced Shipping Notice) but the prescription drugs require compliance documentation and the rest does not. How do you flag product for which you must have T3?
TraceLink solution: Product Track minimizes the complexity. When the T3 comes in from your supplier, the system looks at all the product codes in the EDI 856. If it sees an NDC, it checks master data to determine if it is an exempt or non-exempt product. If it’s exempt, it will treat it as ASN pass-through data; if it is not, it will create a Transaction History for it. It will also treat products without an NDC as ASN pass-through data. Now when you receive
2 – How can you quickly identify and resolve compliance-related exceptions?
Now that you must have accurate compliance documentation for
TraceLink solution: Product Track performs two levels of validation on the incoming 856 ASN to identify exceptions. When the document arrives in the system, it checks for all T3 fields that are required regardless of product origin. If any issues are identified, an exception will be immediately noted, before the product has even arrived, so you can begin working on a resolution with your supplier. This also gives you time to plan for how to handle the problematic product upon arrival.
Assuming the ASN clears this first check, the next check occurs upon shipment receipt, as you tell the system what you received in terms of NDC, quantity, and lot number. Product Track will confirm if you have the right quantities, lot numbers, etc. If you are trying to receive physical product for which you don’t have accurate T3, Product Track will alert you.
At this point, you're also entering product origin into Product Track so it knows if you bought the product directly from the manufacturer, from another wholesale distributor, or from someone else. At that point, the system also performs a check on the additional required fields. Given the origin, did you need a lot number or not? What about transaction date? The system will flag any exceptions here, as well.
Lastly, Product Track allows you to do a partial receipt of a shipment. That means if you get a shipment of 100 units but your T3 only covers 90, you can process those 90 and move them into inventory and only need to quarantine the extra 10. This flexibility minimizes the impact of exceptions.