Life After DSCSA Compliance

In September, the FDA provided the pharmaceutical industry with a 12-month extension to the Drug Supply Chain Security Act (DSCSA). The FDA states that this “stabilization period” is for the industry to finetune their systems and processes. However, it’s also abundantly clear that the DSCSA compliance deadline remains November 27, 2023.

DSCSA compliance will still go into effect on November 27, 2023
Matt Campasano is a senior consultant who specializes in Drug Supply Chain Security Act requirements, serialization, and traceability. He has worked with a variety of life sciences companies in packaging, manufacturing, wholesale distribution, pharmacy and hospital groups.

On that day, three key components of the law will still go into effect. They require your organization to have processes, and the resources to manage them, in place.

  1. Wholesale distributors must accept unit-level data from suppliers, send unit-level data to dispensers (pharmacy and hospital group customers), and maintain transaction compliance reporting.
  2. Dispensers must accept unit-level data and maintain transaction compliance reporting.
  3. Most critically, ALL parties must perform verification of unit-level data against product received before accepting it into inventory.

Wholesale Distributors are Progressing Slowly

The majority of wholesale distributors are aware of these requirements and have been working for years to onboard their suppliers.

However, recent surveys at one “Big Three” distributor revealed only 80% of their suppliers are onboard for unit-level data transmission. Digging deeper, only half of those suppliers (40% of all trading partners) are actually sending data through the established interoperable data feeds. And this says nothing about the accuracy of that data.

If wholesale distributors are not receiving unit-level data matching shipments by November 27, whether due to lack of trading partner connection or some other process exception, their hands are still tied. The DSCSA prohibits them from accepting shipment of those drugs and they could turn away trucks at the dock.  Discouraging as this may be, dispensers are even less prepared.

Significant Concerns around Dispenser Preparation

Where wholesale receiving is a simple comparison of shipment data to truck shipment ID, the dispenser’s role is more involved. They’re the anchor holding these requirements down and delivering on patient safety. Upon receiving shipment at pharmacy locations, pharmacists – not warehouse teams, not technical teams – must perform a verification check of unit-level data against the physical product.

Here’s the issue. Walk into your local big-box retail pharmacy today and ask the folks behind the counter if they’ve received DSCSA training. There’s a high likelihood of blank stares. These are the pharmacists already working long hours to support the rollout of COVID vaccines and booster shots. These are the same pharmacists who recently staged a three-day walkout to protest work conditions at CVS pharmacy locations in the Kansas City, MO area.

It gets worse. The National Community Pharmacists Association surveyed 332 pharmacy operations regarding labor issues and supply shortages. Most notably, 97% of pharmacies reported generally facing a drug shortage and 67% said they had trouble filling open positions.

3 Steps to Take Right Away

It’s evident that simply completing data exchanges is not enough. Your organization needs to have the resources (human and/or technology) to manage unit-level verification processes or risk impacting patient care.

Here’s what you need to do today:

  1. Ask your serialization/compliance software provider how they can support the volume of verifications and receiving transactions at time of peak traffic across your organization while minimizing impact on duties that are not DSCSA-related.
  2. Ask your serialization/compliance software provider how they can support the automation of exceptions handling.
  3. Develop the business processes and document your Standard Operating Procedures. Then train your staff as soon as possible to work out the kinks.

Key Takeaways

  • At least one “Big Three” wholesale distributor is receiving data from only 40% of their suppliers with no guarantee of data accuracy.
  • 97% of pharmacies report facing drug shortages.
  • 67% of pharmacies report trouble filling open pharmacist roles.
  • Organizations MUST ramp up resources (human and/or technology) to manage the DSCSA processes for performing unit-level data verification.