Tag Archives: 2D Barcodes

The supply chain provisions contained within the Drug Quality and Security Act (DQSA)—themselves known as the Drug Supply Chain Security Act (DSCSA)—mark a significant achievement by Congress and the industry to protect the U.S. pharmaceutical supply chain from criminals. It is the first completed attempt since 1987 when the Prescription Drug Marketing Act (PDMA) was enacted by Congress and signed by President Ronald Reagan. In comparison, the provisions of the DSCSA are much more detailed and extensive than the PDMA and they read as if they were heavily influenced by people who solidly understand the scale and complexity of the legitimate supply chain. Which, they were, based on the contribution of the Pharmaceutical Distribution Security Alliance (PDSA)—made up of key stakeholders in the supply chain—in their development. That should ensure that the industry will be able to adopt the technology and process modifications necessary to meet the new law on time.

But will all this also lead to true protection of the supply chain from criminal activities? Will the DSCSA portion of the DQSA end up presenting new and insurmountable barriers against criminals who game the supply chain to their advantage and thereby putting patients at risk? These are the true measures of the success of this type of legislation. How can we know if the DSCSA will have these positive affects? Continue reading How the DQSA Will–And Won’t–Protect The Supply Chain, Part 1 →

Barcodes

Will The FDA Eliminate The Linear Barcode On Drugs?

December 9, 2013 Dirk Rodgers 3 Comments

During last week’s FDA DQSA supply chain stakeholder’s conference call I was heartened by Ilisa Bernstein’s comments about the linear barcode rule (she says the FDA just calls it “the barcode rule”). The question was asked by a caller whether or not the linear barcode requirement might be dropped in light of the 2D barcode requirement contained in the Drug Quality and Security Act (DQSA) since some drug packages are too small to accommodate both barcodes. This is an excellent question and I was happy the caller asked it so directly.

In her response, Dr. Bernstein pointed out that Continue reading Will The FDA Eliminate The Linear Barcode On Drugs? →

DQSA of 2013

FDA: Ready, Set, Hike!

December 5, 2013 Dirk Rodgers 1 Comment

Tuesday’s FDA stakeholder call with Dr. Ilisa Bernstein, deputy director in the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance, was helpful if only to let us know that the FDA has begun to mobilize immediately after the Drug Quality and Security Act (DQSA) was signed into law by President Obama last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law” and “InBrief: Comments on H.R. 3204 by FDA’s Dr. Ilisa Bernstein at PSM Interchange 13”). The call was very thin on what their plan is, but that was the point. Dr. Bernstein wanted everyone to know Continue reading FDA: Ready, Set, Hike! →

Congress, Federal Pedigree

InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill

September 26, 2013 Dirk Rodgers

I just arrived in California a couple hours ago to attend the next California Board of Pharmacy ePedigree Committee meeting later this morning. I was expecting to check into my hotel and go to bed, but as soon as I turned my phone back on I received multiple notices that a new bipartisan, bicameral draft of a pharma supply chain security bill was being circulated for review and comment. The email from the Senate HELP Committee was timestamped at 9:54pm EDT on Wednesday and they want people to comment on it by noon on Thursday. Wow. I still hope to get some sleep tonight, but I wanted to Continue reading InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill →

NDC, UDI

UDI And The Approaching End Of The NDC

September 23, 2013 Dirk Rodgers 7 Comments

UDI Barcode Cake from last week’s UDI Conference

To be honest, I was somewhat surprised when Jay Crowley announced during last week’s UDI Conference that the U.S. FDA had published the final rules for Unique Device Identification (UDI). Its publication starts the clock on a host of new requirements designed to identify most medical devices in the U.S. market with the same standard approach. That is expected to result in the reduction of errors made by medical professionals and also increase the accuracy and efficiency of the supply chain. I’ve become a little jaded about healthcare Automatic Identification and Data Capture (AIDC) deadlines lately and so the fact that one actually happened caught me slightly off-guard. Of course, UDI was Continue reading UDI And The Approaching End Of The NDC →

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? →

Congress, Federal Pedigree

The Federal Lot-Based Pedigree Before Congress

June 3, 2013 Dirk Rodgers 7 Comments

The current drafts of the nationwide pharmaceutical track and trace (Pedigree) bills on the floors of the U.S. Senate and House of Representatives both include an initial lot-based pedigree requirement that may be based on paper or electronic documentation (see “The Politics Of Federal Track & Trace Legislation”). What is a lot-based pedigree and how is it different from one based on package-level serial numbers? Let’s take a closer look at the kind of system that these bills would require. Keep in mind that the Senate bill would mandate this kind of pedigree system for the next 10 years and the House bill would make it permanent.

First of all, according to both bills, pharma manufacturers would be required to Continue reading The Federal Lot-Based Pedigree Before Congress →

Aggregation, Inference

Pharma Aggregation: How Companies Are Achieving Perfection Today

March 26, 2012 Dirk Rodgers 7 Comments

Bottle ID photo courtesy of Optel Vision

One of the biggest challenges for companies in the U.S. pharmaceutical supply chain when the California pedigree law becomes operational after December 31, 2014 will be the need to maximize the efficiency of dealing with serial numbers on each drug package. One way to do that is to maximize the use of “inference” where the case serial number is read and the unit package-level serial numbers are “inferred” from the unit-to-case aggregation information supplied by the upstream trading partner (See my essays “Inference in the Pharmaceutical Supply Chain” and “Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!”).

But the problem with the use of inference is that you need to be able to rely on the accuracy of the aggregation information that your supplier provides to you. There is an element of trust in that—not just that you trust your supplier to be truthful with you but that you trust that your supplier’s case packing processes and systems will always accurately capture and document the unit-to-case hierarchy—or “aggregation”. You must be able to trust that the aggregation information your supplier provides to you will be 100% accurate. That’s a lot of trust. Continue reading Pharma Aggregation: How Companies Are Achieving Perfection Today →

RxTrace