On November 27, 2023, the final phase of the Drug Supply Chain Security Act (DSCSA) goes into effect. By that date, businesses at every level of the pharma supply chain—from manufacturers to dispensers—must implement an electronic, interoperable system to identify, trace and verify the prescription drug products they manufacture, package, distribute or sell in the US.
DSCSA has a big impact on the supply chain, and pharmacies occupy a unique position as they are situated at the end. Dispensers—all entities that distribute prescription drugs directly to patients—are significantly affected by DSCSA. But industry experts estimate that only 40% of dispensers are prepared. In fact, many have the misconception that their primary wholesale distributors will take care of their DSCSA requirements for them. As a result, this misguided belief puts their businesses at legal and financial risk.
Below is a quick checklist of the requirements that pharmacies must meet to help you determine your readiness.
By November 27, 2023, every drug dispenser must have a process in place to:
Confirm that trading partners are licensed and registered.
Dispensers can only do business with authorized trading partners (ATPs), i.e., manufacturers, re-packagers and wholesale distributors who are also DSCSA compliant. This confirmation can be done manually—though not a straightforward process—through the FDA website or state board of pharmacy, or automated with every transaction via ATP credentialing.
Confirm product tracing information to be true, accurate and complete.
There may be a clerical error or discrepancy in the received tracing information. If the discrepancy cannot be resolved and steps for verification are necessary, that could result in product quarantine.
Pass along transaction data with transfer of ownership.
In limited cases, pharmacies, clinics or hospitals may transfer ownership of pharmaceuticals to another legal entity. In these cases, that dispenser must be able to pass along the transaction data with that product.
Store and manage large amounts of data related to drugs.
Product tracing data has to be stored in paper or electronic format for six years in the event of a suspect product investigation. These storage requirements can be overwhelming and time-consuming, especially for smaller dispensers who may not have the resources to invest in a robust data management system.
Quarantine and investigate suspect prescription drugs.
Dispensers must have a defined process in place to investigate any drugs that may be counterfeit, diverted, stolen, intentionally adulterated or unfit for distribution. This also requires working with the manufacturer and other trading partners to ensure patients do not receive illegitimate drugs. Pharmacies must also notify the FDA.
As you consider your approach to DSCSA, keep in mind that it effects almost every department in your organization—from compliance and risk management to sourcing and supply chain to pharmacy operations. Everyone plays a role at some level, and it impacts the entire business.
With just a few months left to meet the DSCSA requirements, it may seem like a tall task. But Systech can help. As a global leader in pharmaceutical serialization and product tracing, we offer the speed, flexibility and expertise needed to get your pharmacy or clinic where it needs to be—on time and on budget. We can guide you through your DSCSA compliance journey and improve your daily business operations at the same time.