By Donna Boulieu, senior product & strategic pricing analyst, for the Preparing for Track and Trace blog series

In our last two posts in the Preparing for Track and Trace blog series, we explained what the Drug Supply Chain Security Act (DSCSA) was and what, as a dispenser, your responsibilities are under the law. We also dove more deeply into details about T3 documentation, how to know when to suspect a drug is suspect or illegitimate, and important dates to know.

To summarize your responsibilities:

  • Confirm that the entities you purchase prescription products from are licensed or registered distributors (unless product is from another dispenser for direct-to-consumer dispensing).
  • Receive product tracing documentation, called T3 data.
  • Store, or have stored on your behalf, T3 data for a minimum of six years and provide reports within 48 hours if requested.
  • Investigate and properly handle suspect and illegitimate drugs.

Details on T3 documentation, illegitimate drugs, and the important dates:

  • T3 refers to the three pieces of product tracing documentation: transaction information (TI), transaction history (TH), and transaction statement (TS).
  • A product is suspect if you have reason to believe:
    • the product is counterfeit, diverted, or stolen,
    • the product was subject to a fraudulent transaction,
    • the product appears intentionally adulterated or otherwise unfit for distribution such that it would result in serious adverse health consequences or death to humans, and/or
    • the product has associated TI information that is inconsistent from one trading partner to the next.
    • A product is illegitimate if you confirm the above. Then you must submit FDA form 3911.
    • Important Phase 1 dates include:
      • November 27, 2019:Verification of saleable returns (applies to wholesalers; however, final guidance delayed until November 2020)
      • November 27, 2020:Pharmacies can only buy/sell serialized product (product encoded with a unique product identifier) unless on exempt list or grandfathered.

What is serialized product?

In November of 2018, you should have noticed serialized product packaging, that included a 2D barcode, resembling a QR code, was being received from prescription drug manufacturers. In a little over one year, pharmacies will only be able to buy or sell serialized products under DSCSA.

Serialized product packaging must include the following information in a 2D barcode and human readable format:

  • National Drug Code (NDC)
  • Serial Number
  • Lot Number
  • Expiration Date

A unique serial number is required down to the package level and must be different for every homogenous case or package. Serializing product in this way is what makes it possible to trace product throughout the supply chain. The new 2D barcodes make it easy to scan this information electronically into systems, and manufacturers are required to affix them, along with the human readable version, to their packages.

Dispensers may need to purchase new hardware, such as barcode scanners and software updates to read and interpret the barcodes. By November 2020, dispensers may only accept product with this product identifier affixed to the label, and they must capture, validate, and store the information for easy retrieval.

What are the exemptions to receiving, storing, and providing T3 data?

The law applies only to prescription drugs as defined by 503(b)(1). (You can view the specifics of 503(b)(1) in this PDF from the FDA.) OTC products are outside the scope of the DSCSA, even those that are sometimes dispensed from behind the counter, such as certain C5 scheduled drugs like Guaifenesin and Codeine Phosphate.

How is the FDA enforcing Phase 1?

With the passing of DSCSA, the FDA is regulating the entire supply chain, putting its purview over manufacturers, distributors, and dispensers. As such, pharmacies need to be aware of the very real danger of non-compliance.

In February 2019, the FDA sent a Form 483 warning letter — the first of its kind — to a trading partner for violations of the track and trace law. The letter states that the wholesaler sent missing and wrong pills to multiple pharmacies. This should be a warning to pharmacies that the FDA is keeping a tight watch on the DSCSA and will reprimand any member of the supply chain that does not adhere to their responsibilities.

Leaving your responsibilities as a dispenser up to your wholesale partners may not be a wise idea because you may not be fully compliant with DSCSA. Here are some questions to consider: How quickly would your wholesaler be able to respond to a request for T3 data if there is a suspect product investigation or inquiry by the FDA (have you signed a service agreement with them)? If you purchase from multiple suppliers, can you easily and seamlessly combine the data to demonstrate “chain of custody” of the Rx products you stock and dispense? How efficiently can you identify which wholesaler you purchased your product from so you can reach out to the correct supplier? If you resell products to another dispenser, will your wholesaler comply and do you need to be registered as a wholesaler? What happens to the T3 data if you choose to leave a wholesaler?

I hope this post has given you more insight on DSCSA regulations including serialization and enforcement. In our next post, we will relate how DSCSA shares the burden of regulations across the supply chain — not just focusing on pharmacies — and how it is designed to ultimately help pharmacies in their quest for patient safety and efficient business operations.