The Healthcare Distribution Management Association (HDMA) recently updated their “HDMA Qs and As on the Drug Supply Chain Security Act (DSCSA)” to version 2.0. This is a very well thought through document that will help companies understand how wholesale distributors are interpreting confusing or ambiguous sections of the law. The document leans heavily toward questions about how wholesale distributors will need to react in various situations, but it will also be a resource that manufacturers, repackagers and dispensers will want to obtain and review. What is really needed is for someone to do the same kind of analysis for questions that mainly affect those other supply chain entities. Continue reading InBrief: HDMA Updates DSCSA Q&A
Progress Toward Serialization!?
Last 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!?
2015 RxTrace U.S. Pharma Traceability Survey Results, Sponsored by Frequentz Now Available!
I 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!
InBrief: The Rx-360 Traceability Data Exchange Architecture White Paper
Last 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
Thank You Bob Celeste!
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 Continue reading Thank You Bob Celeste!
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: Continue reading DSCSA “Serial Numbers”
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
When Will The DSCSA Ever Require Investments In Aggregation?
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 Continue reading When Will The DSCSA Ever Require Investments In Aggregation?
