Preparing For DSCSA – serialized transaction information

Enforcement / Retention

1) When will the FDA and States begin enforcing serialized transaction Data? The DSCSA serialization dates for compliance depend on the eligibility and election of trading partners under the Oct. 09, 2024, FDA Exemption document. McKesson distributors will use that exemption to fully comply with their DSCSA serialization obligations by Aug. 27, 2025. McKesson will continue to share lot-level data until Aug. 27, 2025, and where available, will share serialized data for DSCSA in-scope products through the same portals from which you receive lot-level data today.

2) What action is required for our pharmacy to receive serialized transaction data? In order to receive any serialized transaction data for DSCSA in-scope products from McKesson, you must have a Sold To and Ship To GLN on file with us. The serialized transaction data is tied directly to your GLN. You will continue to receive lot-level transaction data from McKesson distributors until Aug. 27, 2025. Additionally, if you select to use a third-party DSCSA solution provider as your repository, you must complete the enrollment process by contacting your Sales team member.

3) When will I be able to access transaction data? Limited serialized transaction data will be available to customers in December 2023. When the information goes live, you will access your serialized data the same way that you access your lot- level data from SupplyManager^SM or if you have contracted with a 3rd party provider through their service.

4) How long will McKesson keep a record of my serialized transaction data? Per DSCSA guidelines, McKesson will maintain a record of your serialized transaction data for six years.

Serialized transaction information

5) How long will McKesson transmit both lot level and serialized data information? McKesson will transmit lot data for DSCSA in-scope products until Aug. 27, 2025, as per the FDA Oct. 09, 2024, exemption document. Limited serialized data for DSCSA in-scope products became available in December 2023. The availability of a customer’s serialized transaction data for such products depends on the manufacturer’s ability to provide full EPCIS data and the McKesson
shipping distribution center’s capability to capture and transmit that serialized data.
As of Aug. 27, 2025, only serialized transaction data for DSCSA in-scope product will be gathered and distributed. McKesson will maintain lot and serial DSCSA data for six years after the transaction date for such data as required by the DSCSA.

6) Is McKesson planning on aggregating the serialized data so that we can scan just the external tote to verify all the compliance data was received vs. each individual bottle? McKesson will be aggregating the serial information of the individual DSCSA in-scope products to their totes and including that level of detail in the DSCSA transaction data. It is the dispenser’s decision how to use this information. Recent FDA guidance has suggested that customers should confirm DSCSA transaction data was received.

7) How will McKesson provide DSCSA serialized data?  McKesson is making DSCSA transaction data available through our customer-facing portals (Connect, ERA, Customer Center, Lynx and SupplyManagersm online). McKesson’s 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 customer-facing portals, provided that the customer has the required GLN(s). McKesson customers may use our portal link to manage their DSCSA transaction data during the six-year DSCSA record retention requirement. Additionally, customers may opt to have the data transmitted daily using an EPCIS file to their in-house or third-party DSCSA repository for storage.

McKesson Portal Access to DSCSA Serialized Data

8) What is the agreement that pops up the first time I try to access transaction data? There is an agreement titled, “Agreement to Maintain DSCSA-Required Transactional Data.” The agreement is necessary to keep DSCSA data in the McKesson portals. This licensing agreement pops up when you attempt to access the DSCSA data in the portal for the first time. It will also pop up periodically thereafter to re-verify the license agreement. You must accept the agreement to access the data. The agreement also can be printed. Below is a copy of the agreement.

9) Does the traceability report in the McKesson portals provide lot numbers? Currently, when McKesson purchases DSCSA in-scope product directly from the manufacturer, we provide a Direct Purchase Statement in lieu of providing the lot number in the Lot Level DSCSA Transaction Data. Under the FDA October 09, 2024, exemption document, starting August 27, 2025, the Transaction Data from McKesson distributors will contain the lot number, serial number and expiration date of DSCSA in-scope product. McKesson has been incrementally providing this Transaction Data during the Stabilization Period and will continue to do so through this FDA exemption period (i.e. Nov. 27, 2024 – Aug. 27, 2025) as it tests and matures its systems.

10) How do we retrieve older DSCSA data created before the new processes? Customers should continue to access their data on SupplyManager^SM. SupplyManager^SM has a six-year record retention requirement for lot level traceability, which began on January 1, 2015. Additionally, ATTP will be managed to maintain six years of record retention as McKesson builds up data. This will be a function of the ATTP archiving and management.

Connecting through a 3rd Party Provider

11) I have chosen to use a third-party solution provider for my transaction data. What is the process for ensuring that we are set up in ATTP for data to be sent to my third-party provider? If you will be using a third-party solution provider for your transaction data, you should first contact your Sales representative to complete the enrollment process. Have the following details to share with your representative:

• Contact Name for Serialization Responsible Party (Name of third-party solution provider)
• Contact Email Address
• Your GLN, and Global Corporate Prefix
• Expected readiness date (the first date the customer & third-party provider want to receive data from McKesson) or desired date for contact to kick off onboarding The Sales representative will complete the enrollment process and submit to MMSTraceability@mckesson.com.

You will receive a notification of progress and completion of onboarding. The process takes approximately:

• 7 -10 business days to onboard a customer and start sending EPCIS files through an existing solution provider with an established and certified connection.
• 3 to 4 weeks for onboarding with a new solution provider to complete.

12) What does the third-party testing process look like? If you are using one of the service providers which McKesson has already certified and has a connection to pass data, your data will be promoted to production directly. If you choose to test with a certified provider, we will carry out the testing and ask for customer confirmation when the test file is triggered from McKesson’s end. Once confirmed, we will promote them to production and notify them. If you have questions on the transaction data provided by the third-party solution provider, you should contact your third-party vendor directly.

13) Is it possible to get a copy of the third-party agreement for the storage of transaction data for our files? McKesson would not have access to the agreement between the customer and the customer’s third- party service provider. Please contact your service provider directly for a copy of the agreement.

Transaction Data for Complex Ordering

14) Who receives the EPCIS serialized data for 340B product? Where does McKesson send the information? What is McKesson process when there is an error and the pharmacy needs a new EPCIS file? EPCIS data for 340B purchases will be provided to the covered entity, not the contract pharmacy. The covered entity can grant access to EPCIS data to their contract pharmacies, but this must be handled by the covered entity and the contract pharmacy.

15) How will the Drop Ship process work for DSCSA data? The ordering process for drop shipments of DSCSA in-scope products will remain the same as it is now. The manufacturers shipping your product will send you the lot-level DSCSA transaction data. McKesson currently does not provide this data. Our ordering lot-level DSCSA system will indicate a drop shipment occurred but will not have complete DSCSA information as the manufacturer must provide that detail. To improve the process for serialized DSCSA transaction data, McKesson has built functionality to enable it to receive the drop ship serial DSCSA data from the manufacturer and pass it onto the customer. This functionality depends on the manufacturer sending the DSCSA data to McKesson. Even if McKesson provides this service, the manufacturer retains the ultimate obligation to send the data.

16) Does McKesson have visibility to the serialization data of drop ship orders? Does McKesson have a role in the chain of ownership for drop ship orders? For drop ship orders of DSCSA in-scope products, McKesson owns the product prior to transferring that ownership to the customer. However, since McKesson does not possess the product in a drop ship situation, the DSCSA transaction data is created by the shipper. We do expect the shipper to share the data with us which, if received, we will load into our portal or provide to a customer’s third-party DSCSA solution.

McKesson is here to support you during this transition by providing guidance and assistance where possible. We are not able to take action for you. Additional information for dispensers from NACDS, NCPA, HDA and NABP about dispenser requirements is available at www.dscsa.pharmacy.