Preparing For DSCSA – serialized transaction information

Enforcement / Retention

1) When will the FDA begin enforcing serialized transaction Data? The FDA expects the industry to exchange and validate serialized data through the Stabilization Period. McKesson will begin sharing limited serialized data in December 2023 through SupplyManager^SM

2) What action is required for our pharmacy to receive serialized transaction data? In order to receive any serialized transaction data from McKesson, you must have a Sold To & Ship To GLN on file with us. The serialized transaction data is tied directly to your GLN. You will continue to receive transaction data as you do today. 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. Important note: At this time, McKesson will not require a GLN to ship DSCSA applicable product; however, look for more details on the exact date you will be required to have a GLN on file for continued shipping of product as it will be expected in advance of Nov. 26, 2024.

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 both lot and serialized data throughout the Stabilization Period, which ends November 27, 2024. Limited serialized data will be available in December 2023.

Customers serialized transaction data availability will be dependent on the shipping DCs capability to transmit serialized data and the manufacturer’s ability to provide full data. As of Nov. 27, 2024, only serialized transaction data will be gathered and distributed. McKesson will maintain lot and serial DSCSA data for six years after the transaction as required by the DSCSA regulations.

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 individual products sold to the totes with serial information and include that level of detail in the DSCSA transaction data. This is part of our requirements for shipping. It is the dispenser’s decision how to use this information. Recent FDA guidance has suggested that customers should reconcile the product identifiers against the DSCSA transaction data 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 SupplyManager^SM online). A global 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. Please note, a GLN is required in order for records to post to ATTP. McKesson customers may use their 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.

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? Yes. Lot numbers are required for indirect sourced products under Lot Level traceability, which began in 2015. Direct sourced products are required to be identified in a direct purchase statement in the document in lieu of providing the lot numbers and the manufacturers transaction date. This is a specific requirement in the DSCSA law. Lot numbers in addition to serial numbers and expiration dates are a requirement of Serial Level traceability which begins on November 27, 2023.

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 will remain the same as it is now. As for DSCSA drop shipments, currently the manufacturers shipping your product send you the DSCSA transaction data; McKesson does not provide these data. There is a memo in the ordering system that a drop shipment occurred, but it is not complete DSCSA information as the manufacturer is required to provide that detail. McKesson will be informing the manufacturer of the customer’s GLNs to use when creating the EPCIS data. We have asked our manufacturers to begin sending the EPCIS files to McKesson for drop shipments made to McKesson customers. The serial DSCSA data will still come from the manufacturer. If the manufacturer supplies the DSCSA data to McKesson, we plan to serve as a mailman to deliver it to the customers DSCSA serial endpoint. This is in development and is contingent upon the manufacturer sending the DSCSA data to McKesson. The manufacturer retains the 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? McKesson is a part of the ownership of drop ship product. The data though for a drop ship is created by the shipper as an exception to the normal rules. We do expect the shipper to share the data through us. For customers using a third-party DSCSA solution, we will pass it across to them. For customers using the portals, it will be available there.

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.