Four Steps to DSCSA Stabilization: A look ahead at the stabilization period

Last week LSPedia hosted its monthly DSCSA webinar, “Four Steps to DSCSA Stabilization.” The event consisted of an overview of current and future DSCSA requirements including details on the FDA’s stabilization policy, a panel discussion and a wide-ranging Q&A.

Panelists included LSPedia CEO Riya Cao, VP of Services Rose Campasano, SVP of Sales and Marketing Daniel MacKinnon and compliance expert Tish Pahl of Olsson Frank Weeda Terman Matz PC.

To watch a replay of this webinar and Q&A or review the slide deck, head over to our Supplier Connect portal. To gain access to this portal, fill out the Supplier Connect Access Request form.

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What’s changed now that the November 27, 2023 deadline has passed?

During the webinar, Pahl covered a variety of things that trading partners should “already have been doing” since the November deadline. They are listed below.

• All trading partners must be authorized and only do business with other Authorized Trading Partners (ATPs).
• Trading partners must have systems for “verification.”
• All covered drug packages and homogenous cases trading partners purchase and sell should have a product identifier, unless grandfathered or subject to an FDA-granted waiver, exception, or exemption.
• Trading partners must provide, receive, and maintain lot-level transaction data with each transaction with trading partners – the Transaction Information (TI), Transaction History (TH) (where required), and Transaction Statement (TS) (i.e., “TI/TH/TS” or “3Ts”).
• 3Ts must be provided for all changes of covered product ownership.
• A trading partner must be able to respond with lot-level transaction data to appropriate requests for information from government officials.
• Dispensers can only return products to the trading partner they purchased from, and their seller must “associate” the return with transaction data.
• Manufacturers and repackagers must be able to respond to requests from authorized trading partners to verify product identifiers, that is, confirm that the identifier is one the manufacturer or repackager assigned to a product.
• Trading partners must maintain suspect/illegitimate product records and transaction data for 6 years.

Now that the deadline has passed, it is important to realize that violating the DSCSA is a “prohibited act” under the federal Food, Drug and Cosmetic Act and regulators have and will continue to enforce the DSCSA.

Trading partners may still be working to stabilize and achieve full interoperability for the Enhanced Security measures that took effect on the deadline. The FDA is foregoing enforcing noncompliance, but progress towards compliance is required.

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Requirements added on November 27, 2023

New requirements were added on November 27, 2023. These are referred to as “Section 582(g)(1),” or “package-level” or “enhanced drug distribution security” or “2023” requirements.

All Pharmaceutical Trading Partners Must:

• For each transaction, exchange TI and TS securely, electronically, and interoperably.  
• The TI must include the unique identifier of each package in the transaction (referred to as “serialized data”).
• Have systems and processes for verification of product identifiers at the package level.
• Be able to respond to appropriate tracing requests and trace products at the package level.  
• When receiving a saleable return, must associate that return with the TI and TS associated with that product. ‍

As the FDA has noted, these requirements can be satisfied by Electronic Product Code Information Services (EPCIS) files with accurate product identifiers for each package; exchanging serialized data in EPCIS enables package-level tracing.

To learn more about connecting and utilizing EPCIS files, stay tuned for upcoming 2X Connect webinars.

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The FDA’s DSCSA Stabilization Policy

As mentioned previously, the FDA stated that it “generally expects” trading partners to have systems and processes in place to meet all old and new requirements.  

The administration does not intend to take action to enforce its Enhanced Security measures for one year – if its expectation is met that trading partners are not slowing or stopping their efforts to become compliant. This is what the stabilization period is for – it assumes you’ve already met the basic requirements and are using this year to address the more complex requirements, which means testing and polishing your systems with your trading partners.

Additionally, the FDA expects continued use of current methods to exchange and store transaction data, investigate and report suspect or illegitimate product and handle saleable returns.

Compliance expert Tish Pahl also mentioned in the webinar that the FDA issued its Verification Compliance Policy, extending the following measures through November 27, 2024:

• Wholesale distributors must verify the product identifier with the manufacturer on each return before resale.
• In suspect product investigations, dispensers must verify with the manufacturer the product identifier of least three packages, or 10 percent of such suspect product whichever is greater, or all packages if there are fewer than three.

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To sign up for future webinars and stay on top of DSCSA compliance, head to our upcoming webinars page.