Drug Supply Chain Security Act pharmacy responsibilities are complex. They can be confusing. But the clock is ticking to be ready for the November 27, 2023, deadline. Let’s do a quick recap for pharmacies.
What is the U.S. Drug Supply Chain Security Act?
The U.S. Drug Supply Chain Security Act, enacted on November 27, 2013, establishes a system to track and trace prescription drugs in a fully serialized supply chain. It calls for end-to-end traceability and electronic interoperability to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the U.S. supply chain.
So far, the DSCSA has mostly focused on lot-level traceability — exchanging information about every package of medication so stakeholders can see exactly where it has been. Enactment culminates in November 2023, with complete unit-level serialization of the U.S. drug supply chain. This means stakeholders will have to electronically track products at the individual package level.
Drug Supply Chain Security Act pharmacy responsibilities: definitions
Pharmacies are referred to as “dispensers” in the DSCSA. The legislation defines a dispenser as “a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.”
If you dispense only products to be used in animals, you are not a dispenser under the DSCSA.
How to comply with the DSCSA
As we said above, the Drug Supply Chain Security Act pharmacy responsibilities are complex. Let’s break them down into easy-to-understand pieces.
You must exchange information about every drug you buy and who handled it each time it changes ownership in the United States.
The DSCSA calls this “product tracing information,” and it has three components, collectively referred to as “T3 information”:
- Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form)
- Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership.
- Transaction history (TH), an electronic statement with the TI for every transaction going back to the manufacturer. TH is required until the November 27, 2023, deadline.
You must receive, store, and provide product tracing documentation
You can accept prescription drugs only if they have proper tracing information, and you must store the information for six years. You must also generate and provide all information when you sell a prescription drug to a trading partner.
You can only do business with authorized trading partners (ATPs)
And speaking of trading partners, if you can’t confirm your they’re licensed or registered, you can’t do business with them. If they’re not authorized, their access to the U.S. pharma supply chain will be severely restricted or denied altogether. Read our in-depth ATP blog series for all the details.
You must investigate and properly handle suspect and illegitimate drugs
Suspect and illegitimate drugs include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution — the problem the DSCSA was designed to eliminate. Pharmacies must quarantine and investigate these drugs to determine if they are fake. If you make this determination, the next step is to work with the manufacturer and take specific action to ensure the bad drug does not reach patients/consumers. You must also notify the FDA and your trading partners about the drug.
You must authenticate and verify drugs
This is what’s coming in 2023. You’ll have to be able to authenticate and verify all the medicines you buy before you can sell them. The fundamental requirement is that TI (transaction information) must include a product identifier (PI), which includes serial numbers and expiration dates. The Electronic Product Code Information Services (EPCIS) is likely to be the standard the industry will use to enable this exchange.
We’re writing this on November 24, 2021. Yes, it’s the day before Thanksgiving. (Happy Thanksgiving!) It’s also almost exactly two years from the DSCSA implementation deadline. That may seem like a long time, but …
It is definitely not a long time. There’s a lot to do to ensure you’ll comply with your Drug Supply Chain Security Act pharmacy responsibilities. If you aren’t sure you’ll be ready, contact us to schedule a short demo of our DSCSA solutions. Our team of supply chain experts will design a solution to ensure you meet all DSCSA requirements and remain compliant forever.
And if you’re looking for something to read over the Thanksgiving holiday, download our “Dispensers and DSCSA 2023” white paper. It drills down into what we talked about today and is a great reference tool to have on hand as you prepare for the full serialization of the U.S. pharma supply chain.