Dirk Rodgers

Dirk Rodgers
Dirk Rodgers is a Regulatory Strategist where he writes regularly in an exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has posted over 400 essays on these specific topics and is the author of the book “The Drug Supply Chain Security Explained” (Amazon). A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners. An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. In 2002 he became employed by Cardinal Health, one of the big 3 U.S. drug distributors, where he studied many approaches to applying serialization and track & trace technology to solve supply chain integrity problems and also improve supply chain efficiencies. In 2003 he represented Cardinal Health on Accenture’s seminal Jumpstart project, an early pharmaceutical supply chain RFID pilot. Dirk has served on HDA, NCPDP, EPCglobal, GS1 and GS1 US technical and standards work groups. He served as co-chair of the GS1 EPCglobal Drug Pedigree Messaging (DPMS) work group and the GS1 Network Centric ePedigree (NCeP) work group, among others.
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Recent Posts

2019-07-31 | China Accelerates Pharma Traceability Regulations in New Document

China’s National Medical Products Administration (NMPA) has been very active in the last year, producing documents that address various aspects of their planned pharma traceability mandate. It has been several years since the previous pharma serialization and tracing regulation was suspended. The future system described in the new final guidance documents is significantly different from that old suspended system. Where the old system avoided the use of global standards—and thus it was a...

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2019-07-10 | Verification Router Service Solves 2019 DSCSA Mandate

The Drug Supply Chain Security Act (DSCSA) contains a series of escalating mandates for companies in the pharmaceutical supply chain. Each deadline falls on the anniversary date of the law’s adoption on November 27, 2013. For 2019, one of the new requirements is for wholesale distributors to begin verifying saleable returns using the Standardized Numerical Identifier (SNI) before they can redistribute them.

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2019-06-24 | Russia: The Deadlines Are Almost Upon Us and The Clock Keeps Ticking

The deadlines for the pharma labeling system (cryptographic serialization and tracing system) MDLP, in the Russian Federation are fast approaching. Companies marketing drugs in the Russia Federation targeting seven named nosologies must register with CRPT, the governments service provider, by July 8, 2019. Then on October 1, 2019, packages of drugs targeting those seven named nosologies must be serialized according to very Russia-specific technical guidelines, and production and shipments...

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2019-04-18 | The PDSA's New DSCSA Governance Proposal Explained

On March 25, 2019 the Prescription Drug Security Alliance (PDSA) published the first of three white papers that describe their proposal for establishing a new, non-profit governance organization that would be responsible for ensuring interoperability of the Drug Supply Chain Security Act (DSCSA) solutions. This first paper is called “A Proposal: Governance for DSCSA Phase II Interoperability”. In addition, PDSA also published another paper called “An Overview: PDSA Vision for Phase II...

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2018-10-02 | Reducing the Complexity of Global Pharma Regulatory Compliance

First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging -- regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Regulations differ between markets, and can change often enough meaning regulatory professionals must be prepared to adjust processes, procedures and filings...

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2018-09-06 | China Announces New Drug Traceability Regulations.

In late August, the China National Drug Administration (CNDA) posted three new draft guidance documents detailing a proposed National Drug Regulatory Information Standard and Traceability System. Chinese versions of the drafts are available now but the agency is requesting feedback from stakeholders and the public to be submitted by September 20, 2018. Final versions are likely to appear soon after that.

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2018-08-21 | Egypt, India and Pakistan Delay Their Pharma Serialization Deadlines

In 2017, the largest market for pharmaceuticals—the United States—delayed enforcement of their key pharma serialization requirement. The revised deadline for serialization and verification here is November 27, 2018, one year later than originally specified by Congress in the Drug Supply Chain Security Act. A few months before that delay was announced, Brazil withdrew their entire regulation, changed their law, and published a more reasonable timeline that would result in full serialization...

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2018-07-18 | Russia Flirts with A ‘Crypto Code’

A few months ago, the government of the Russian Federation adopted Order Number 791-r, which appears to have significance for pharma serialization there. The primary deviation from the pharma serialization specification that has dictated the government pilot in Russia since early 2017 is the addition of two new data elements to the datamatrix barcode on secondary packaging. For the pilot, the datamatrix barcode contained:

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2018-03-16 | 3 Important New DSCSA Resources

  

From now through November 2020, the deadlines for meeting the Drug Supply Chain Security Act (DSCSA) happen every year. The pace of change has accelerated and companies need to remain vigilant to stay compliant. Fortunately, there are three important new DSCSA resources that became available in the last two weeks.

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2018-02-23 | The 2017 GS1 US Barcode Assessment

Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson.  The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.

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