dscsa serialization requirements

[Blog] DSCSA 2023 – what is coming?

Key areas of DSCSA`s new requirements

 
The announcement that FDA officially confirmed the DSCSA 2023 Interoperability Deadline is a hot topic. The new requirements affect different aspects of track and trace process and meantime challenge all supply chain participants. Now is the time to meet the requirements and to be prepared on time.

 
 

From ASN to EPCIS

 

Currently, the process of information exchange, as transaction information (TI) and transaction statements (TS), is being done through the ASN (Advanced Ship Notice).  In the DSCSA, this is set to be changed with the transition to EPCIS (Electronic Product Code Information Services). EPCIS will enable the electronic product codes (EPC) to be exchanged securely between the different supply chain participants. The adoption of the new standard is a keystone of DSCSA 2023 serialization, allowing the seamless automatic communication and exchange of authenticated data.

 
 

Are you “ATP”?

 

ATP means Authorized Trading Partner. Under the new requirements, the exchange and communication will be permitted only for and between supply chain participants that are ATPs. To be “authorized” means:

–       If you are a wholesaler – you must have a state license

–       If you are a manufacturer – you must have a valid FDA Entity Identifier
 
If you are not an authorized trading partner, you will have severely restricted access to the US pharma supply chain. All stakeholders as manufacturers, contract manufacturers, 3PLs, dispensers and wholesales must meet the DSCSA criteria. This will ensure automation, efficiency and accuracy between the different parties.

 
 

VRS – verification on next level

 

Verification Router Service (VRS) is an automated service for verifying a drug`s PI (Product Identifier) validity. VRS manages the rapid and secure exchange of data between the parties in the process of verification of saleable returns requests. Under DSCSA saleable returns verification requirements the mandatory steps of saleable return request are as follows:

  1. A wholesaler initiates a verification request
  2. A manufacturer provides a verification response within 24 hours

 
 

And what about serialization?

 

The serialization under the DSCSA brings new requirements or rather extends them. The transaction information (TI) must include the product identifier (PI). More as we already mentioned, instead of exchanging the data on lot level by ASN, it will be transmitted to EPCIS. The main goal behind these new DSCSA serialization requirements is to enhance the security of prescription drugs in the U.S. supply chain, improving healthcare and patient safety.

 


Sources:

https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

https://www.fda.gov/media/147175/download

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