All posts by Dirk Rodgers

Dirk is the founder of RxTrace where he writes regularly on the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has written hundreds of essays on those specific topics. 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. Overall, Dirk's thought leadership has helped to expose hidden complexities and reveal surprising consequences and implications of drug serialization and pedigree laws around the world. Dirk is the author of "The Drug Supply Chain Security Act Explained". View Dirk's LinkedIn Profile Follow Dirk on Twitter
DSCSA, FDA

The 2014 FDA DSCSA Workshop

WorkshopThe U.S. FDA held their first industry workshop focusing on the new Federal Drug Supply Chain Security Act (DSCSA) last Thursday and Friday at FDA Headquarters in Silver Spring, MD.  The goal of the workshop was to help the FDA collect ideas and preferences from industry stakeholders and technology providers for meeting the January 1, 2015 DSCSA requirement to exchange Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS).  The FDA must publish a draft guidance document on the same topic before November 27, 2014, so this workshop, plus the responses to the recent docket, will help them write that draft.

The workshop was held in a large room with eleven big tables, each with about 18 chairs around them.  The FDA had Continue reading The 2014 FDA DSCSA Workshop →

UDI, Uncategorized

UDI Deadline For Class III Medical Devices Quickly Approaching

UDIexample.small.ucm368901There is a lot of angst in the pharma community right now about the fast approaching DSCSA first deadline for the exchange of transaction data, but the medical device community is dealing with an even earlier deadline:  the September 24, 2014 deadline for UDI on class III medical devices.

The FDA UDI web page lists the following requirements for the September deadline, now less than five months away:

Continue reading UDI Deadline For Class III Medical Devices Quickly Approaching →

DSCSA, HDMA

Just Released – The HDMA EDI ASN Guidance For DSCSA

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HDMA ASN for DSCSA coverNOTICE:  The HDMA has updated this guideline again only a few months after this essay was published.  Please see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again” for additional information.  — Dirk.

The Healthcare Distribution Management Association (HDMA) has just published their much anticipated new guidance on applying the Electronic Data Interchange (EDI) 856 Advance Ship Notice (ASN) transaction set toward compliance with the new U.S. Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA).  HDMA members and non-members can download a copy of the new document here.  Make sure you look for “HDMA Electronic Data Interchange (EDI) Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA“.  (See the image to the right.)

The new guidance is voluntary, like all HDMA guidance (see “GS1 Identifiers and EPC’s in EDI Messages: Important New HDMA Guidance” and “Updated HDMA Bar Code Guidance: A Must Read“), but companies who Continue reading Just Released – The HDMA EDI ASN Guidance For DSCSA →

UDI

Bringing UDI and the Global UDI Database to Life

1491-125x125_Static_DatesRxTrace is proud to sponsor the 2014 UDI Implementation Workshop to be held in Baltimore on May 20-22.  The UDI Implementation Workshop is specifically for Class III medical device manufacturers who are in immediate need of information and guidance from the UDI experts at the FDA to meet their September 24, 2014 compliance deadline, and for those Class I and II Device manufacturers that need to jumpstart their UDI adoption efforts.

The FDA UDI Team will conduct a roll-up-your sleeves / deep-dive workshop covering all components of the UDI regulation and the Global UDI Database (GUDID) guidance.  This workshop is strictly focused on critical information exchange, expanded interaction, and heightened networking designed to deliver immediate and actual results in your UDI implementation initiative.  If you need to meet the September deadline, don’t miss this workshop.  It is perfectly timed to give you the boost you need to be ready on time. Continue reading Bringing UDI and the Global UDI Database to Life →

DSCSA, FDA

DSCSA: Many Questions, Few Answers

Jung_ConnieConnie T. Jung, RPh, PhD, Acting Associate Director of Policy and Communications, Office of Drug Security, Integrity and Recalls, in the Office of Compliance within the U.S. FDA Center for Drug Evaluation and Research (CDER) delivered an overview of the new Drug Supply Chain Security Act (DSCSA) during a webinar last Monday.  The title of the webinar was “FDA Perspectives on Implementation of the Drug Supply Chain Security Act”.  The webinar is one of a series that the Healthcare Distribution Management Association (HDMA) plans to offer on related topics through the remainder of the year.  If you missed it, don’t worry, they will post the recording and the slides on the HDMA event web page.

I have to give credit to Dr. Jung and the FDA in general for being willing to make presentations like this at this time.  The material they cover is a good overview of the new law at a high level.  The tough part for the speaker comes at the end when the floor is opened up for Q&A.  There were a number of very good questions asked by participants on this one, but most were answered with simple reference to future guidance.  Here is Dr. Jung’s answer to Continue reading DSCSA: Many Questions, Few Answers →

DSCSA, exemptions

Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?

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Exempt signEver since the Drug Quality and Security Act (DQSA) was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), more and more people are asking the question, “Does my drug have to follow the DQSA?”.  Recently I was on a monthly industry call put on by one of the Big 3 wholesale distributors to discuss the Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA.

I was surprised how many people asked the wholesaler if their specific product was covered or exempt.  Of course, asking a wholesale distributor if your own product must follow a particular Federal law is not likely to get a usable response and that was true in this case, but it did not stop the next person from asking the same kind of question.

In fact, no one can answer that question for you.  Even the FDA can’t answer that question for you.  I can’t answer that question for you.  Only YOU can answer that question based on your knowledge of your product’s characteristics and a careful reading of certain provisions of the DSCSA.  I can help you with that part.  Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? →

DSCSA

DSCSA: Transaction Statement

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TS.iStock_000008261949SmallerThis is the third in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January.  The previous essays in this series include DSCSA Transaction Information (TI) and DSCSA Transaction History (TH).   The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines Transaction Statement (TS) this way:

“(27) TRANSACTION STATEMENT.—

The ‘transaction statement’ is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—

(A) is Continue reading DSCSA: Transaction Statement →

DSCSA

DSCSA: Transaction History

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TH.iStock_000000755934SmallerThis is the second in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January.  Last week’s essay was about DSCSA Transaction Information (TI).  On the surface, Transaction History (TH) looks simple.  The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines TH this way:

“(25) TRANSACTION HISTORY.—

The term ‘transaction history’ means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.”

According to this simple definition, Continue reading DSCSA: Transaction History →