药品供应链安全法案》常见问题解答

July 18, 2023

4 min read

McKesson has been closely following the Drug Supply Chain Security Act (DSCSA) regulation since it was introduced in 2013. We have continued to stay heavily engaged with the FDA, the manufacturing community and other stakeholders to help ensure that we are compliant and that our implementation plans are appropriately executed across all aspects of the pharmaceutical supply chain in preparation for the November 27, 2023, effective date.

Overview:

What is DSCSA?
What traceability changes will be implemented in 2023?
How will McKesson provide DSCSA transaction data to my organization?
When will I be able to access transaction data?
How will products/items and trading partners be identified in the new interoperable electronic exchange?
What is the new Rx drug return process and when is it effective?
Will requirements for saleable returns change?
What changes do I need to make prior to the DSCSA regulation taking effect on Nov 27th, 2023?

What is DSCSA?

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

2. What traceability changes will be implemented in 2023?

DSCSA Transaction Information will change from lot-based to serial-based transactions. Currently, DSCSA transactions are traced at the lot level with a transaction history and a transaction statement.

On November 27, 2023, in addition to the previous requirements for DSCSA transaction information, the DSCSA will require that the serialized product identifier information be added to the DSCSA Transaction Information.

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= packing, shipping, receiving, returns, etc.)

Beginning on November 27, 2023, the current transaction history will be sunset and electronic-based approaches will be used among all trading partners to meet the enhanced requirements.

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

3. How will McKesson provide DSCSA transaction data to my organization?

McKesson将make your DSCSA transaction data available to you through our customer facing portals (Connect, Customer Center, Lynx, and Supply Manager(SM) online).

A repository called ATTP will store serialization data from McKesson and will allow searching, downloading and printing upon request. You may use the portal link to manage your DSCSA transaction data for the entire six years of record retention requirement.

In addition, you may opt-in to have the data transmitted daily to your in-house or third-partyDSCSA repository to store on your behalf.

4. When will I be able to access transaction data?

Data connections and testing for the ability to receive the daily push will begin after July 2023. When the transaction data capability is live, a link will be housed on a DSCSA designated page within your McKesson ordering portal. In addition, instructions and training will be made available before the rollout to help educate you about how to use the new data feature.

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

GS1 standard identifiers will be used for product and party/location identification in the interoperable electronic exchange.

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

6. What is the new Rx drug return process and when is it effective?

A detailed Rx drug returns process communication is being developed and will be shared at a later date. To comply with the DSCSA, the new returns process will be effective November 27, 2023.

7. 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, including:

We will ask you, the customer, to match and confirm that the serial number of the returning item was purchased from McKesson.
The distributor (McKesson) must verify the product identifier of the returned Rx drug package to the manufacturer’s assigned data beginning on November 27.
The distributor (McKesson) must also associate the returned Rx drug with its original DSCSA transaction data from McKesson’s initial sale to the customer. After November 27, this association is at the serial product identifier level.

Rx drug returns where McKesson cannot verify or associate the product at the serial product identifier level cannot be accepted for saleable return under the DSCSA.

A detailed product returns process communication will be shared at a later date.

8. What changes do I need to make prior to the DSCSA regulation taking effect on November 27, 2023?

Prior to November 27, 2023, you 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 you have purchased. McKesson, unfortunately, cannot respond to regulators on your 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.
- Beginning this Summer, DSCSA transaction data will be accessible through McKesson portals or in your in-house or third-party system if you 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 at the product identifier level cannot be accepted for saleable return under the DSCSA.
Dispensers should continue to perform suspect product reviews and investigations as you have since 2015. Use of the DSCSA transaction data may be necessary when conducting suspect product investigations.
McKesson将provide training to support your DSCSA transaction data education efforts throughout the summer and early fall.

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 atwww.dscsa.pharmacy.