Answering Your Questions about Drug Supply Chain Security Act (DSCSA)

What is DSCSA?

The Drug Supply Chain Security Act (DSCSA), signed into law on November 27, 2013, outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. These requirements enhance the Food and Drug Administration’s (FDA) ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. Implementing these requirements also improves the detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

What traceability changes will be implemented?

Special Note on the FDA Announced Stabilization Period: The FDA has stated that they do not intend to enforce the requirements for serialized DSCSA transaction data and saleable returns until November 27, 2024. During this “Stabilization Period,” McKesson will continue to provide lot based DSCSA transaction data and continue to apply the current requirements for returns. McKesson also will begin, in parallel, to provide serial DSCSA transaction information during the Stabilization Period. Serial DSCSA transaction information will contain lot numbers, serial numbers, and expiry dates for all DSCSA products.

  • A new serial number is provisioned by the manufacturer at each level to be uniquely identified.
  • Each serial number must be tracked through all transactional events across the supply chain (events pertaining to packing, shipping, receiving, returns, etc.)

McKesson will use FDA-recommended Electronic Product Code Information Services (EPCIS) standards to provide and maintain the data associated with transaction information and transaction statements.

How will McKesson provide DSCSA transaction data to its customers?

McKesson will make DSCSA transaction data available through our customer-facing portals (Connect, Customer Center, Lynx and SupplyManagersm online). A data repository called ATTP (Advanced Track and Trade for Pharmaceuticals) will store serialization data from McKesson and allow searching, downloading, and printing upon requests made through the portals. McKesson customers may use the portal link to manage their DSCSA transaction data for the entire six years of the DSCSA record retention requirement.

In addition, customers may opt-in to have the data transmitted daily to the customer in-house or third-party DSCSA repository to store on their behalf.

When will customers be able to access transaction data?

When the transaction data capability is live, customers will receive instructions on how to access that data. A link will be housed on a DSCSA-designated page within the McKesson ordering portal. In addition, detailed instructions and training will be made available before the rollout to help educate our customers about how to use the new data feature.

How will products/items and trading partners be identified in the new interoperable electronic exchange?

GS1 standard identifiers are used for product and party/location identification in the interoperable electronic exchange. GS1 is a not-for-profit information standards organization.

  • Products will be identified by a Global Trade Identification Number (GTIN).
  • Trading partners will be identified by a Global Location Number (GLN).

What is a GLN?

A GLN, or Global Location Number, is a unique identifier that lets businesses know who is involved in transactions and where things are located throughout the supply chain.

McKesson is in the process of gathering the GLNs for our customers and loading them into our systems. Establishing and submitting GLN number(s) is imperative to continue to conduct business throughout the supply chain.

A GLN is required before a customer can begin receiving serialized DSCSA transaction Information.

How do I access my GLN number?

GLNs are typically created by the organization that is being identified by subscribing to a license from GS1.

To aid in the adoption of GLNs for DSCSA purposes, McKesson and other distributors have purchased a group license allowing them to submit information to GS1 for GLN creation for identification of independent and small customers.

A cross-functional team is working to collect and enter all customer account data into the GS1 system.

All customers must provide two GLN numbers to designate their status:

  • Sold to
  • Shipped to

These numbers may be the same for some customers if their sold-to and ship-to addresses are identical.

How can customers create a GLN?

Customers that do not meet the criteria under McKesson’s group license will need to establish their own GLNs. If customers do not have GLNs currently, they can have GLNs created by visiting the GS1 website at gs1us.org. Please be aware that a small registration fee is involved.

Will requirements for saleable returns change?

Yes, there are increased requirements, defined in the federal law governing DSCSA, that will be imposed on saleable returns before the end of the Stabilization Period such as the following:

  • McKesson will ask the customer to match and confirm that the serial number of the returning saleable item was purchased from McKesson.
  • McKesson must verify the product identifier of the returned package to the manufacturer’s assigned data.
  • McKesson must also associate the returned product with its original DSCSA transaction data from McKesson’s initial sale to the customer. After November, this association will begin using the serial product identifiers.

Product returns where McKesson cannot verify or associate the product cannot be accepted for saleable return under the DSCSA.

What changes should customers make before the Stabilization Period ends on November 27, 2024?

Prior to November 27, 2024, customers should make changes, including but not limited to the following:

  • All customers (dispensers, health systems, pharmacies, etc.) should be prepared to respond directly to regulators if asked about tracing information for products they have purchased. McKesson, unfortunately, cannot respond to regulators on the customer’s behalf.
  • All trading partners, including dispensers, are expected to be able to search the repositories where their serial DSCSA transaction information and transaction statements are stored and retrieve the requested information upon request.
    • DSCSA transaction data will be accessible through McKesson portals or in the customer’s in-house or third-party system if they request this information to be transferred. A link to this data will be added to the portals once this feature goes live.
  • All trading partners will need to check the serialization number before making a return to McKesson to ensure that they purchased the serial product identifier on the product in question from McKesson before initiating the return.
    • Product returns where McKesson is unable to verify or associate the product cannot be accepted for saleable return under the DSCSA.
  • Dispensers should continue to perform suspect product reviews and investigations as they have since 2015. Use of the DSCSA transaction data may be necessary when conducting suspect product investigations.
  • McKesson will provide training to support education efforts to support implementation of the DSCSA’s requirements.

As a pharma manufacturer leveraging a 3PL, what DSCSA services does McKesson offer to ensure that my business is compliant?

McKesson Third Party Logistics (3PL) offers an End-to-End DSCSA Solution, Integrated Scanning Solution and additional DSCSA Support Services. Below is a brief overview of these solutions. For more information, please reach out to 3PLdscsainquiries@mckesson.com.

  • End-to-End DSCSA Solution – This solution is backed by our deep industry expertise and best-in-class Advanced Track and Trace (ATTP) platform by SAP. When enrolled in this solution, customers can enjoy the simplicity of having all DSCSA-related activities housed with one partner.
  • Integrated Scanning Solution – For clients that choose to use an outside vendor for their DSCSA repository, we offer a solution that seamlessly integrates transaction data taking place within our facilities into our customers’ systems.
  • Additional DSCSA Support Services – We offer additional services that can allow our customers to customize any of our DSCSA solutions or support their unique needs. Our additional services include:
    • Identify or assign missing customer GLNs
    • Product authentication inquiry support
    • Suspect product investigations
    • Support for 3911 filing with the FDA for illegitimate product
    • Trading partner license status check
    • Support for migrating from third-party repository to McKesson ATTP repository
    • Exception handling from a dedicated team
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