HDA 2024 Traceability Seminar: How Prepared Is Pharma for DSCSA Compliance?

PC: Following FDA’s implementation of the stabilization period last year, what is the pharma supply chain's overall preparedness in adhering to DSCSA’s Nov. 27, 2024 compliance deadline?

Bernstein: We're in a good place. It's not ready 100%, but FDA is implementing this one-year stabilization period, which allowed the supply chain to mature, and the connections really helped. We're at a much better place than we were last year, and we're closer to really being where we need to be, but there are still connections between trading partners where the data quality is poor, where there's discrepancies in information that's provided, and those need to be cleaned up. If there's a discrepancy or you don't have data, but you have product, that product can't move to the next trading partner, so a wholesaler can't sell it to a dispenser, and that means that product may not get to the patient who is waiting for it in the pharmacy.

All of these little end bits of data quality and making sure that your systems and processes are working and interoperable—that all has to be fixed and cleaned up. If you don't have that, if you're not ready, or your trading partner isn't ready, you got to go back and get that exemption, or WEE, that I talked about earlier.

PC: Although not required per the DSCSA, what have you heard in terms of companies tagging their products with RFID labels?

Bernstein: Ten years ago—or even 15 years ago, we thought RFID was the next wave of making sure that you know where the product is, but we're not there. In fact, the DSCSA requires that two-dimensional barcode, and that takes enough real estate on the label and the package, that's where all of the focus is. Some companies are using RFID to help identify where a product is within their four walls, but it's not being used—as far as I know—for that tracking and tracing of a product through the supply chain. It's all focused on the two-dimensional barcode.