As the clock continues to tick toward the November 27, 2023, U.S. Drug Supply Chain Security Act (DSCSA) deadline, we thought it was a good time for a recap. Our DSCSA summary will hit the major milestones, changes from the FDA, and compliance requirements.
We’ll also include an updated timeline graphic that first appeared during our three-part DSCSA webinar series last summer, which dealt with authorized trading partners (ATPs), EPCIS, and the Verification Router Service (VRS). We wrote about those topics twice just last week: Check out our FDA DSCSA Guidance Update: EPICS, ATPs, and the Countdown to 2023 and the Q&A with our SVP of Product and Strategy Herb Wong.
Now, on to the DSCSA summary: everything you need to know in 5 minutes.
What is the DSCSA?
The DSCSA is a 10-year plan to transform the U.S. pharmaceutical supply chain. It became law in November 2013, as Title II of the Drug Quality and Security Act (DQSA), and has been rolled out since 2015. Implementation culminates on November 27, 2023, at which time the U.S. pharmaceutical supply chain will be fully serialized.
The U.S. Food and Drug Administration (FDA) says the goal of the DSCSA is “to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.”
Furthermore, the DSCSA “will enhance [the] FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful” and “improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.”
Who has to comply?
Manufacturers, wholesalers, dispensers, repackagers, and third-party logistics providers (3PLs) must comply with DSCSA if they want to do business in the United States.
1. Product identification (serialization). A unique product identifier (PI), such as a bar code, must be placed on certain prescription drug packages.
2. Product tracing. Stakeholders must provide information about a drug and who handled it each time it’s sold. This includes the following:
- Transaction information (TI) includes the product name; its strength and dosage form; its National Drug Code (NDC); container size and number of containers; lot number; transaction date; shipment date; and the name and address of the businesses from which and to which ownership is being transferred. Note: We’ll be writing more about NDCs soon.
- The transaction statement (TS) is a paper or electronic attestation by the business transferring ownership of the product that it has complied with the DSCSA.
- Transaction history (TH) is an electronic statement with the TI for every transaction going back to the manufacturer. Note: TH will not be required after the November 2023 deadline.
For the record, the FDA defines “transaction” as the “transfer of product between persons in which a change of ownership occurs.”
3. Verification (VRS). Stakeholders must establish systems and processes to verify PIs for certain prescription drugs packages. The Verification Router Service (VRS) enables a rapid, secure exchange of data to do this
4. Authorized trading partners (ATPs). The DSCSA also says that if you’re not an ATP, your access to the U.S. pharma supply chain will be severely restricted or denied altogether. All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers and their trading partners must be ATPs
If you want to know more, read our in-depth explanations of the VRS and ATPs. Or just contact us today to talk to one of our DSCSA experts!
Detection and response + notification. Stakeholders must quarantine and promptly investigate suspect or illegitimate drugs. They must also notify the FDA and other interested parties when they find such drugs.
Licensing. Wholesalers must report their licensing status and contact information to the FDA. Third-party logistics providers must obtain a state or federal license.
DSCSA Summary: Timeline
The FDA has delayed the rollout of the DSCSA two times (September 2019 and October 2020). However, an FDA official said in August 2021 that there would be no more delays. November 27, 2023, is a done deal.
If you have any questions about this DSCSA summary, contact us today. There might be one or two things that surprised you — like the sunsetting of the transaction history (TH) requirement — and we want to make sure you’re sure about what’s happening.
Our extensive writing about the law is a valuable resource, but nothing beats spending 15 minutes with one of our supply chain experts. So schedule a short demo of our DSCSA compliance solution. Our No. 1 priority is to help you understand the regulations and be prepared for the full serialization of the U.S. pharma supply chain next November.
And if you happen to be going to the HDA Traceability Seminar in Washington, D.C., next month, drop us a line here to arrange a meeting and be sure to catch Herb Wong in the “EPCIS Onboarding Across the Supply Chain” panel discussion and his roundtable about industry readiness for November 2023.