Today’s question: What is the Drug Supply Chain Security Act (DSCSA)?
The Drug Supply Chain Security Act (DSCSA) represents the most significant change to pharmaceutical distribution and manufacturing processes in decades.
When the act was originally passed, DSCSA implementation was supposed to occur at a much faster pace. However, the FDA had to push back the deadline on two separate occasions, as manufacturers and distributors simply weren’t ready to adapt to the changes.
We’ve written extensively about the legislation, which was passed on November 27, 2013. But with the deadline for full compliance quickly approaching, we thought a quick overview was in order. So let’s answer the question, What is the Drug Supply Chain Security Act?
Understanding the Drug Supply Chain Security Act?
If you’re a pharmaceutical company — a manufacturer, wholesaler, dispenser, repackager, or third-party logistics provider — you must comply with the Drug Supply Chain Security Act (DSCSA) if you want to do business in the United States.
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.” The Act “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.”
The law has been rolled out in phases since it was passed nearly 10 years ago. Implementation culminates on November 27, 2023, at which time the U.S. pharmaceutical supply chain will be fully serialized.
DSCSA Compliance
In the buildup to the rollout of DSCSA’s final layer of regulations, the FDA has partnered with numerous industry leaders to discuss various aspects of the Drug Supply Chain Security Act.
These discussions cover DSCSA compliance topics, technical requirements, and mechanisms for requesting information from pharmaceutical manufacturers. Stakeholder experiences during the implementation process are also considered.
Additionally, the FDA published another round of DSCSA guidance documents in March of 2023. These documents provide concrete definitions for terms like “illegitimate product” and “suspect product,” along with other key information.
Pharmacies, healthcare organizations, and other members of the pharmacological supply chain can use these definitions to analyze the authenticity of drug products and protect consumers.
You can find more information about DSCSA 2023 implementation and overall readiness by visiting the FDA’s website.
Key Requirements of the Drug Supply Chain Security Act
Formerly known as the Drug Quality and Security Act (DQSA), the DSCSA sets forth sweeping labeling and tracing requirements for the pharmaceutical industry.
By providing comprehensive FDA guidance, the act facilitates the accurate tracing of products from the point of production to distribution to health systems and beyond. However, product tracing is only a single component of the DSCSA.
When structuring the act, the FDA grouped DSCSA requirements into the following categories:
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 transaction information (TI), a transaction statement (TS), and a transaction history (TH), collectively known as “T3” information. Read our “Dispensers and DSCSA 2023” white paper for more about T3 information.
While all aspects of the DSCSA are important, its product tracing provisions will likely have the most significant impact on the pharmaceutical supply chain. Pharmacists, dispensers, distributors, and all other members of the supply network can leverage traceability data to ensure product authenticity and protect consumers from the dangers of counterfeits.
3. Product verification
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. See more about VRS below.
4. 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.
5. Licensing
Wholesalers must report their licensing status and contact information to the FDA. Third-party logistics providers must obtain a state or federal license.
Looking Forward: DSCA 2023
The FDA has delayed the rollout of the DSCSA two times, giving the industry extra time to prepare. However, an FDA official recently said there will be no more delays. November 27, 2023, is a done deal.
In terms of what’s next, take a look at our “DSCSA 2023: The Future of Pharmaceutical Traceability in the United States” blog post. This gets into the granular details of the transformation that’s going to happen in 2023, but here are the basics of what to expect:
Serialization
Serialization relies on product identifiers (the “PIs” we mentioned above), which include serial numbers and expiration dates. For 2023, all transaction information (the “TI” we mentioned above) must include the PI. TI includes the following:
- The product name
- The product’s strength and dosage form
- The product’s National Drug Code
- The container size and number of containers
- The lot number
- The transaction date
- The shipment date
- The name and address of the businesses from which and to which ownership is being transferred
Authorized trading partners
Put simply, the DSCSA says that if you’re not an authorized trading partner (ATP), your access to the U.S. pharma supply chain will be severely restricted or denied altogether. All manufacturers, wholesale distributors, repackagers, third-party logistics providers, and dispensers and their trading partners must be ATPs. Learn more about ATPs in our DSCSA Authorized Trading Partners guide.
Verifying drugs
The DSCSA’s saleable returns verification requirement stipulates that wholesalers must verify all returned drugs before they can be reintroduced to the supply chain. This is done by verifying a drug’s PI. A wholesaler must initiate a verification request to the drug’s manufacturer, then the manufacturer must provide a verification response within 24 hours. The Verification Router Service — the VRS — is what enables the rapid, secure exchange of data between these parties. Like everything else in the DSCSA, we’ve written extensively about the VRS. Our “DSCSA Saleable Returns Verification Requirement: Just the Facts” article is a good place to start.
Final thoughts
What is the Drug Supply Chain Security Act? The DSCSA makes pharma stakeholders responsible for securing the U.S. supply chain. It doesn’t matter if you’re a manufacturer, wholesaler, repackager, third-party logistics provider, or a dispenser — the law affects how you conduct business. Your compliance depends on making sure you can meet your responsibilities.
That’s where rfxcel comes in.
A fully serialized pharma supply chain is just two years away. It’s important to use this time to get your systems in place. We have almost 20 years of experience providing the pharmaceutical industry with leading regulatory and compliance software. So if you aren’t sure if you’re going to be ready for DSCSA 2023 and want to see a short demo of our solutions — or just want to know more about your responsibilities — contact us today. Our DSCSA experts will work directly with you to design a solution that meets your specific needs, no matter your role in the supply chain.
In the meantime, you can hear directly from our experts in our “Plan for DSCSA Readiness” webinar and our DSCSA 2023 webinar series. These are great resources to help you better understand the law.
