DSCSA Archives - The DRE Professor

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What Impact Will The DSCSA Have On Labor?

November 19, 2021

According to the article: "With many companies either facing or concerned about labor shortages in manufacturing, an expert from Cardinal Health notes that outbound scanning alone may require a 12 to 15% increase in headcount in their operations."

HDA Survey Offers Some Troubling DSCSA Prep Results – HealthcarePackaging.com

September 16, 2021

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According to the article, "With just two years left to meet the Nov. 2023 DSCSA requirements, a readiness survey shows that there is much work to be done in drug supply chain traceability. 57% of manufacturers surveyed have no successful data connections in production environments."

FDA Adds New DSCSA Guidance Documents

July 19, 2021

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The FDA is issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain.

Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements? – BioProcess Online

October 5, 2020

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EDDS will be enabled by the establishment of standards for the interoperable exchange of data, combined with the inclusion of individual serial numbers in the product shipment transaction information transmitted for the NDCs/Lot #s sold and distributed.

Mediledger completes FDA blockchain pilot with 7 of top 10 pharma firms – Ledger Insights

February 18, 2020

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California Designated Representative Training – for wholesalers or 3PL According to the article: “Blockchain startup Mediledger has published the results of its FDA blockchain pilot for the pharmaceutical supply chain. Numerous separate groups applied to the FDA and ran pilots for the Drug Supply Chain Security Act (DSCSA) 2023 milestone for package-level tracing, with this […]

Here comes drug importation – Pharmaceutical Commerce

December 19, 2019

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3 distinct Board-approved California Designated Representative online training classes for wholesalers, 3PL, reverse distributors. Earns a training affidavit. According to the article: “The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored […]