Tag Archives: serialization

Data Exchange

Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?

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SteadyState.2015.to.2023The use of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) in the U.S. pharmaceutical supply chain has expanded over the last year, due entirely to its recognition by the FDA as a valid method for passing the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) as required by the Drug Supply Chain Security Act (DSCSA).  The Healthcare Distribution Management Association (HDMA) has encouraged that expansion by publishing a “how-to” guide for meeting the requirements of the DSCSA using an ASN (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).

Although not everything has worked out Continue reading Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday? →

serialization

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 Continue reading Progress Toward Serialization!? →

RxTrace Traceability Survey

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

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

Rx-360, Traceability models

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

DSCSA Product Identifier

DSCSA “Serial Numbers”

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????????????????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: Continue reading DSCSA “Serial Numbers” →

DSCSA Webinar Series

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: Continue reading New DSCSA Webinar Series →

serialization

Pharmaceutical Traceability Forum Offers Strategic and Solution Focused Discussions to Prepare Organizations for the Upcoming Compliance Deadlines

PharmaTraceability Forum.300x250RxTrace is pleased to announce a partnership with the Pharmaceutical Traceability Forum, taking place March 30-April 1 in Boston, MA. In line with the upcoming regulatory and compliance deadlines, the Pharmaceutical Traceability Forum is the #1 event bringing together the brightest minds in the industry to discuss personal experiences and best strategies for preparing your serialization programs for 2015 and beyond.

Download the event agenda or request a copy via e-mail.

The Forum program, created for Continue reading Pharmaceutical Traceability Forum Offers Strategic and Solution Focused Discussions to Prepare Organizations for the Upcoming Compliance Deadlines →

Decommissioning

The Coming Battle Over Decommissioning At The Pharmacy

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Certificate of Serial Number Death
Certificate of Serial Number Death

The U.S. pharma supply chain will operate under two major phases as dictated by the Drug Supply Chain Security Act (DSCSA).  We are now operating under the first major phase.  Well, OK, it won’t be fully operational until July 1st when dispensers (see “Who Is A DSCSA Dispenser?”) are required to begin receiving, saving and retrieving Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for each shipment they receive.  Drug manufacturers, repackagers and wholesale distributors were supposed to begin exchanging those documents on January 1st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).  But be aware that according to the DSCSA, as of January 1st, all trading partners must be properly licensed and everyone may only buy and sell drugs legally from/to companies who hold a valid State or Federal license.  Those and other requirements of the DSCSA were not delayed by the FDA.

The second major phase of the DSCSA will not occur until November 27, 2023 when the law transforms into something that is fairly nebulous right now.  That is, between now and Continue reading The Coming Battle Over Decommissioning At The Pharmacy →