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The U.S. Food and Drug Administration mandates that pharmacies and health systems must:
- Verify and track products with electronic data sharing by November 2023.
- Find solutions that support unit-level EPCIS event data.
- Implement a secure data exchange network between trading partners.
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New challenges demand digital solutions.
Pharmacies and Hospital dispensers, Wholesale Distributors, Manufacturers, Repackagers, and 3PLs all need to have an electronic, interoperable Traceability System by the final phase of Drug Supply Chain Security Act (DSCSA) implementation in 2023.
- Tracking pharmaceutical products at the package level.
- Identifying, verifying, and responding to suspicious and illegitimate products.
- Making recalls faster and less costly.
The Food and Drug Administration (FDA) considers interoperability to be the solution for a secure drug supply. In order to achieve this, pharmacies and health systems need to ensure their processes are interoperable and meet the three key DSCSA requirements before time runs out.
ACHIEVE DSCSA 2023 REQUIREMENTS IN THREE STEPS
1. Exchanging data
Interoperable data exchange allows trading partners to securely share important traceability information.
You must share the required Transaction Information (TI) and Transaction Statements (TS) in electronic form, including the complete serialized product identifier at the packaging level-containing the product's Serial Number, its Expiration Date, Lot Number, and the National Drug Code (NDC). Electronic TS will replace the Advanced Shipping Notice (ASN) in providing Transaction History (TH), thereby upgrading the current T3 into a digital T2.
2. Verifying medications
All trading partners in the pharmaceutical supply chain should be able to verify the identifier of a suspect product at the packaging level when requested by a trading partner or other agent.
Health systems and pharmacies need to design and implement scalable processes that:
- Capture and store large volumes of serialized product data.
- Keep data for retrieval, cross-reference matching, and information sharing about suspect products.
- Respond to partner notifications about potentially illegitimate products within 24 hours, on a compulsory basis.
3. Tracking information
You are prohibited from accepting ownership of a pharmaceutical product without having access to your complete T3 that must be provided by the previous owner, containing Transaction Information (TI), Transaction Statements (TS) and Transaction History (TH).
This information will only be available electronically when November 2023 comes around. Make sure you are ready to receive and share data electronically when transferring ownership of a drug. Retain information, transaction histories and statements for at least 6 years.
Share data with any partner! Learn about the EPCIS language
Get ready for Electronic Product Code Information Services (EPCIS), DSCSA's data exchange standard.
A single shared language is needed to make pharmaceutical data exchange work. EPCIS interprets each supply chain process as a specific event (packaging, shipping, or receiving, for example) and helps you with an industry standard format for efficiently communicating commercial information about any stage of a given product.
- Communicate essential information regarding supply chain processes from a standard, error-free language.
- Allow your company to easily connect with any international trading partner.
Meet regulatory requirements without interrupting your operations!
These official materials will help you and your business along your traceability journey