Category Archives: serialization

InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA

June 8, 2015 Dirk Rodgers

Drawing from the GS1 Healthcare GTIN Allocation Rules document showing how to assign GTINs in multi-pack scenarios. Click image to enlarge.

The U.S. Drug Supply Chain Security Act (DSCSA) requires manufacturers and repackagers to place DSCSA-specific “product identifiers” on all drug packages and homogeneous cases by November 27, 2017 (2018 for repackagers). These product identifiers must include a Standardized Numeric Identifier (SNI), which is composed of the drugs National Drug Code (NDC) and a unique serial number (for more on DSCSA “product identifiers”, see “The DSCSA Product Identifier On Drug Packages“, for more on the SNI, see “FDA Aligns with GS1 SGTIN For SNDC“, and for more on the NDC, see “Anatomy Of The National Drug Code“).

A common question is, what is the smallest level of packaging that must be serialized?. The DSCSA text provides the answer. Continue reading InBrief: ‘The Smallest Individual Saleable Unit’ In The DSCSA →

serialization

Progress Toward Serialization!?

March 30, 2015 Dirk Rodgers

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!? →

serialization

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

January 19, 2015 IQPC

RxTrace 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 →

serialization

Pharma Industry Attention Returns to Serialization

January 5, 2015 Dirk Rodgers

Before the passage of the Drug Supply Chain Security Act (DSCSA) on November 27, 2013, the pharma industry was focused pretty well on getting the California-mandated serial numbers on 50% of their drug packages by last Thursday (January 1, 2015), and the remainder of their products by next January. But that mandate evaporated by federal preemption as soon as the Federal bill was signed into law. From that moment on, everyone turned their sights toward meeting the data exchange requirements of the DSCSA by last Thursday (see “DQSA: How Should Transaction Data Be Exchanged?”). Of course, just before Christmas, the FDA pushed that effective date out to May 1, 2015 (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).

That extension in enforcement is a blessing to a few Continue reading Pharma Industry Attention Returns to Serialization →

serialization

InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014

August 4, 2014 Dirk Rodgers 1 Comment

It is time for the RxTrace look at the estimated rise in the percentage of drugs in the U.S. supply chain that are serialized. Every year we take a look at this topic while longingly wishing that someone would perform a real study and publish the numbers. However, it may not make much difference from here on out because it will be impossible for drugs without serial numbers to exist in the U.S. supply chain in just a few years. So let’s take a look. Continue reading InBrief: Estimated Rise in Serialized Drugs in The U.S. Supply Chain, 2014 →

serialization

Eli Lilly: “Serialization Needs Standardization”

October 21, 2013 Dirk Rodgers 3 Comments

Last month, Eli Lilly posted a video about their serialization initiative on YouTube. It features Grant Lindman, Manager of Lilly’s Global Anti-Counterfeiting Operations, and David Colombo, Commercial Implementation Leader of Lilly’s Global Serialization Program talking about their global serialization program. It is worth a listen. Continue reading Eli Lilly: “Serialization Needs Standardization” →

serialization

Will Generic Drug Manufacturers Serialize Their Drugs In Time?

July 9, 2013 Dirk Rodgers 2 Comments

The one thing all pharmaceutical manufacturers can count on, regardless of whether or not the U.S. Congress passes a new track and trace regulation in this or future sessions, is that unit-level serialization will be a necessity on drug packages sold into the U.S. market within the next few years. We have all been paying close attention to the draft legislation that has been moving through the two houses of Congress for several months now, but there is no doubt that unit-level serialization will be required whether something passes at the federal level or not. The only questions are, exactly which year will it be required and what else will be required?

We know that Continue reading Will Generic Drug Manufacturers Serialize Their Drugs In Time? →

Anti-counterfeiting, serialization

The Different Goals of Anti-Counterfeiting Technologies and Serialization

November 26, 2012 Dirk Rodgers 6 Comments

While writing last Monday’s RxTrace essay I ran out of time before I could get to the point I originally intended to make, so here is the conclusion to my thoughts on the topic.

The point I wanted to make is that there is a big difference between the goal of serialization and that of most other anti-counterfeiting technologies. Most anti-counterfeiting technologies covered in Mark Davison’s essential book on the topic, “Pharmaceutical Anti-Counterfeiting, Combating the Real Danger from Fake Drugs“, are technologies that a given manufacturer chooses to place in or on their drug, or on their drug’s packaging so that they can later differentiate it from potential counterfeit versions. That is, so that they can later “authenticate” only the drugs that they truly manufactured.

The decision a given manufacturer makes about which anti-counterfeiting technology(ies), if any, to use for a given drug for a given market is Continue reading The Different Goals of Anti-Counterfeiting Technologies and Serialization →

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