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Progress Toward Serialization!?

2014 enough time graph.zoomLast week I announced the availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results that are sponsored by Frequentz.  You should download a free copy of the report here.  This week I want to look at another interesting finding taken directly from the report.  It shows that progress is being made by drug manufacturers, repackagers and CMO/CPOs toward meeting the 2017 (2018 for repackagers) deadline for adding serial numbers to the drug packages they produce for the U.S. market.  That requirement comes from the Drug Supply Chain Security Act (DSCSA) enacted in November of 2013.

One of the many questions we asked Read the rest of this essay »

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2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available!

graphI am proud to announce the free availability of the 2015 RxTrace U.S. Pharma Traceability Survey Results, sponsored by Frequentz.  You can download the new free report here.

This year’s results were very interesting because most of the responses came in during the critical time just before the 2015 DSCSA requirements were to go into effect.  The questions asked were designed to elicit opinions on a wide range of topics, including the respondent company’s ability to meet the regulations on time, their technology choices and practices.  This year Read the rest of this essay »

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InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper

rx-360-logoLast week, Rx-360, a pharma supply chain consortium aimed at patient safety through a secure supply chain, quietly published the white paper on Traceability Data Exchange Architecture (TDEA) (see “Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture”).

This is a new addition of major importance to the thin collection of public resources companies have available to understand the scope and the specifics of pharma serialization and traceability regulations around the world—and that’s just the first half of the document.  In fact, that half is so complete and well written that it should be downloaded and read immediately by anyone facing those regulations anywhere in the world…especially if Read the rest of this essay »

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Thank You Bob Celeste!

Bob Celeste

Bob Celeste of RCPartners

I would be willing to bet that almost every regular reader of RxTrace knows who Bob Celeste is, and most of you have probably already heard that he is ending his long tenure with GS1 US.  Last fall that organization announced that Bob would continue into the new year as a consultant, and shortly after that, he would transition his GS1 Healthcare US work group facilitation work to others.  Bob reminded everyone on his weekly industry calls of that schedule about two weeks ago and by the end of this month he will no longer fill that role.

Bob started working for GS1 back when Read the rest of this essay »

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DSCSA “Serial Numbers”

????????????????I often write about the fact that drug manufacturers and repackagers that sell into the U.S. market must put “serial numbers”, or “serialize” their drug packages and homogeneous cases before November 27, 2017, but what exactly does that mean?

Let’s break it down.  The Drug Supply Chain Security Act (DSCSA) defines the term “Product identifier” this way:

PRODUCT IDENTIFIER.—

The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”  (Section 581[14])

Back in March of 2010—3 ½ years before Congress passed the DSCSA—the FDA published final guidance called “Guidance for Industry, Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages”, which defined the term “standardized numerical identifier (SNI)” this way: Read the rest of this essay »

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New DSCSA Webinar Series

??????????????????????????Do you need to understand the U.S. Drug Supply Chain Security Act (DSCSA) but do not have time or budget to attend a conference?  Webinars are the ideal way to get the same information you would collect at a conference without the travel hassles, expense and lost time.  That’s why Riya Cao of LSPediA and I have decided to offer a new series of webinars aimed at various important DSCSA topics.  We have announced three initial dates and topics and registration is currently open for all three.  They include: Read the rest of this essay »

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When Will The DSCSA Ever Require Investments In Aggregation?

Packaging Hierarchy.  Drawing by Omega Design

Packaging Hierarchy. Drawing by Omega Design

I have been outspoken on the question of whether or not the Drug Supply Chain Security Act (DSCSA) requires companies in the supply chain to provide their customers with serial number-based aggregation data prior to 2023.  In my view, it does not, but others disagree, saying that there are requirements in the law that lead to the need for aggregation data during that time.  I do not agree with that either.  If you would like to review those arguments and find out exactly what “aggregation data” is, here is a list of RxTrace essays you should read:

Date Published Title/link
March 26th, 2012 Pharma Aggregation: How Companies Are Achieving Perfection Today
November 22nd, 2013 DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?
February 10th, 2014 Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…
June 9th, 2014 The Aggregation Hoax and PIA

BUT WHAT ABOUT AFTER 2023?

The DSCSA requires the FDA to conduct at least 5 topical public meetings between now and Read the rest of this essay »

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Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?

??????????????We are now more than six weeks past the date that the DSCSA originally mandated drug manufacturers, repackagers and wholesale distributors to pass Transaction Information (TI)Transaction History (TH), and Transaction Statements (TS) to their customers in the U.S. and save a copy for six years (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”).  Of course, just before Christmas, the FDA pushed out that part of the requirement until May 1, 2015 to ensure that the requirement did not induce or exacerbate drug shortages (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).

Despite the delay, many companies are already passing the required data to their trading partners through Electronic Data Interchange (EDI) Advance Shipment Notices (ASNs) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).  In fact, the vast majority of companies have Read the rest of this essay »

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