2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors

By |2021-11-16T08:50:29-05:0011/16/2021|

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act (DSCSA) mandates package level traceability by November 2023. Cardinal Health and McKesson are requiring that manufacturers provide fully aggregated [...]

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements

By |2021-11-08T17:08:01-05:0011/08/2021|

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November 27, 2023, the Big 3 distributors are accelerating this timeline and requiring that data by November 2022. Cardinal Health and McKesson [...]

Info Sheet: Serialization Execution

By |2024-06-19T21:39:49-04:0011/08/2021|

Serialization: Value Beyond Compliance Info Sheet Download PDF After years of phased implementation and a stabilization period, the FDA is poised to begin enforcement of federal DSCSA serialization regulations across the end-to-end pharmaceutical supply chain. EUFMD directives in Europe are also in place with other standards around the globe advancing too. The [...]

DSCSA Saleable Return Requirements: What the Changes Mean

By |2020-11-20T09:34:26-05:0011/19/2020|

On October 22, the FDA issued a new guidance document: Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product – Compliance Policies The guidance includes a 3-year delay in enforcing the DSCSA's saleable returns verification requirement for distributors. The enforcement start date is [...]

Building the Downstream Commercial Supply Chain for Launch

By |2024-02-06T10:19:44-05:0008/28/2020|

Building the Downstream Commercial Supply Chain for Launch PDF Version An emerging pharmaceutical company was preparing for its first commercial product launches with two products progressing through the clinic. Approvals and launch events were targeted within one year of each other. The products were similar in technology and formulation. The first anticipated approval [...]

New Challenges in Serialization & DSCSA

By |2024-01-05T09:55:14-05:0004/28/2020|

Converge Supply Chain Series webinar on 6/18/20 New Challenges in Serialization & DSCSA Now that federal DSCSA serialization regulations are being enforced for U.S. manufacturers, focus is shifting from first-time implementation to the challenges in serialization execution, management and delivery of business value. Forward-thinking companies are developing strategies for analyzing serialized data to identify [...]

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