DSCSA – T3 documentation, illegitimate products, and dates to know

August 29, 2019By Behind the Shelf Blog, Preparing for Track and Trace blog series, Resources focused on Independent Pharmacy

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

In our last post in the Preparing for Track and Trace blog series, we explained what the Drug Supply Chain Security Act (DSCSA) was and what your responsibilities as a dispenser are under the law.

To summarize:

  1. Confirm that the entities you purchase prescription products from are licensed or registered.
  2. Receive, store, and provide product tracing documentation, called T3 data.
  3. Investigate and properly handle suspect and illegitimate drugs.

A Closer Look at T3 Documentation

In this post, I’m going to go into more detail about T3 documentation, how to know when to suspect a drug is illegitimate, and touch on some important dates to know.

T3 refers to the three pieces of product tracing documentation: transaction information (TI), transaction history (TH), and transaction statement (TS). Here is some detail about what needs to be included from those you purchase drugs from and what you must provide when transferring ownership to another trading partner.

Transaction Information (TI) – Includes:

  • the name of the product
  • strength and dosage form
  • NDC
  • container sizePharmacist checking drug
  • number of containers
  • lot number
  • date of transaction
  • date of the shipment, if more than 24 hours after the date of the transaction
  • business name and address of the seller and the purchaser

Transaction History (TH) – Paper or electronic statement that includes the transaction information for each prior transaction going back to the manufacturer of the product.

Transaction Statement (TS) – Paper or electronic statement that the entity transferring ownership in a transaction:

  • is authorized under the Act
  • received the product from an authorized party
  • received transaction information and a transaction statement from the prior owner of the product
  • did not knowingly ship a suspect or illegitimate product
  • had systems and processes in place to comply with verification requirements
  • did not knowingly provide false transaction information
  • did not knowingly alter the transaction history

Suspicion of Illegitimate Product

As mentioned previously, you must institute a process to quarantine and investigate suspect or defective products, and if the product is verified as illegitimate, you must notify the FDA and trading partners within 24 hours. So what is considered a suspect product? A product is suspect if you have a reason to believe:

  1. the product is potentially counterfeit, diverted, or stolen,
  2. the product was subject to a fraudulent transaction,
  3. the product was intentionally adulterated or appears otherwise unfit for distribution such that it would result in serious adverse health consequences or death to humans, and/or
  4. the product(s) TI information is inconsistent from one trading partner to the next

A product is considered illegitimate if you have credible evidence that shows the above is true. The FDA gives examples of:

  • altered product information
  • missing information on the label
  • looks different than product on shelf
  • no “Rx only” symbol
  • bubbling on label
  • foreign language
  • lot numbers or expiration dates do not match the outer/inner container
  • missing or wrong package inserts
  • damaged or broken seal
  • open package
  • different product name than FDA approved version

Important Upcoming Dates – Phase 1

Even though DSCSA was first enacted in 2013, the roll out has been in phases. In November of 2018, serialized product began coming from manufacturers as part of Phase 1 (although previously-manufactured product remains in the supply chain and can be distributed without concern assuming all transaction information is verified). Here are some additional Phase 1 dates to be aware of in 2019 and 2020.

November 27, 2019: Verification of saleable returns

November 27, 2020: Pharmacies can only buy/sell serialized product (product encoded with a product identifier)

In our next post, we will discuss what serialized product is, what the exclusions are to receiving, storing, and providing T3 data, and how the FDA is enforcing Phase 1.