Achieving DSCSA Compliance – Unit Level Traceability

pharma labeling regulationsMeeting the final phase of DSCSA regulation will require serialization technology

What problems can drug traceability help prevent?

Counterfeit and contaminated drugs have proven a menace to public health and safety by denying safe and effective treatments, exposing patients to potentially lethal contaminants, failing to treat contagious diseases, and even leading to increased microbial resistance.

The economic consequences to pharmaceutical companies and the economy at large can range from expensive recalls, to lost jobs, decreased consumer confidence, and the diversion of revenues from pharmaceutical research and development.

By the National Association of Boards of Pharmacy’s account, 95% of internet drug outlets have been found to be out of compliance with federal and state pharmacy laws and practice standards.

Components and Timing of DSCA

For participants from drug manufacturer to dispenser, the FDA’s Drug Supply Chain Security Act (DSCSA) has transformed processes in the drug supply chain that cannot occur overnight. Components of regulation have been phased in since first signed into law in 2013, with a deadline for interoperable, electronic tracing of products at the unit level by November, 2023.

DSCSA regulation requires that pharmaceutical companies embed standardized product information on each individual packaged drug.  It also requires any member of the drug supply chain to be validated as an authorized trading partner. The goal is for illegitimate products to be identified, trading partners to be notified when they are, and transaction blocking to occur to prevent distribution.

This has all required new product labeling and barcodes with unique identifiers, and by November, 2023, will require track-and-trace at the unit level. Each drug package must have a serial number in a datamatrix with lot and expiration date, and every unit should have a chain of custody. Ultimately, tracing at the unit level should then identify counterfeits by serial number as the number will be invalid or have previously shown up elsewhere.  If a sale is attempted in California by the serial number with a chain of custody showing it should be on the east coast, it should then be readily identifiable as an illegitimate product.

Achieving DSCSA Compliant Drug Serialization

Technology to read, interpret, and store the required information in the 2D datamatrices is the only way to efficient unit-level traceability.

The benefits of a vision system for drug serialization go beyond basic tracking:

  • Better forecasting – predictive analytics based on realtime data. Artemis Vision systems build in real-time stats such as total items validated or failed in a given time period, average and maximum processing times, etc.  Manufacturers can adjust production with this data. Distributors can reduce waste (for instance, by distributing earlier expiration dates first, avoiding spoilage).
  • Images in addition to data provide an extra level of visibility.
  • If a recall does happen, impacts can be limited to the unit level rather than lot level.
  • Speed.  From a dispenser point of view, since hundreds of products from various vendors need to make the change to 2D codes, there is likely to be a mix for some time of both 1D codes and 2D codes that need to be read.  The key thing is to add this traceability without hurting efficiency.  Artemis Vision’s validation systems can automatically read either code type without speed disruption.

Artemis Vision has been helping clients meet these regulations through systems that integrate seamlessly with existing processes. Our systems can also query customer databases against scanned and decoded images to verify NDC and RX data along with creating item level traceability to a patient. Implementing these solutions in ways that don’t add to cycle time is key.  When the final phase of regulation takes effect, businesses that have not designed systems may struggle as the regulation does create a requirement to scan every product – with a handheld scanner if you aren’t careful.  The businesses that have thought through how to establish a chain of custody without scanning individual products by hand will be ready to enjoy success in the new environment.

Want to talk to us about your own DSCSA compliance? Contact us.