Dear FDA:
Thank you for inviting interested parties like me to provide our thoughts on the new NDC format that you think will be necessary in 10 to 15 years (see “FDA Seeks Input On The Future Format of the National Drug Code”). I hope you can make it that long, but regardless, now is certainly the time to begin working on a replacement. Continue reading An Open Letter To The FDA: New NDC Format Public Meeting
Tag Archives: 2D Barcodes
I Receive My First Serialized Drug From My Pharmacy: Is It Right?
Normally drugs dispensed by American pharmacies are repackaged into the “standard” amber vial. The pharmacy places their own label on that bottle so the patient normally doesn’t receive the manufacturer’s package that would have the new 2D barcode mandated by the Drug Supply Chain Security Act (DSCSA). There are a few drugs that are not repackaged by US pharmacies, like most things in an inhaler and drugs in “compliance packaging” like birth control pills. But even then, the pharmacy puts their label on the package
somewhere.
One of the few drugs I take daily is a statin, which has always been put into an amber bottle by my pharmacy. A few months ago I received a three months supply, and to my surprise, the pharmacy dispensed the prescription in the manufacturer’s original 90-count bottle, and there was the DSCSA 2D barcode on the label. The pharmacy label was positioned so that it formed a “flag” and did not cover the 2D barcode, and the pharmacy label was easily removed to expose the entire manufacturer’s label. This drug was made by Lupin Pharmaceuticals, a generic drug manufacturer base in India. How did they do? Continue reading I Receive My First Serialized Drug From My Pharmacy: Is It Right?
3 DSCSA Requirements You Can Totally Ignore
The Drug Quality and Security Act (DQSA) was constructed back in 2013 by Congressional staff, with input from the FDA, members of the industry and who knows who else. There was one bill in the House of Representatives and a different bill in the Senate. Once these bills passed their respective houses, they formed a conference committee who merged the two bills into the final text that we know today as the DQSA (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). Chapter 2 of that act is the Drug Supply Chain Security Act (DSCSA). Most readers of RxTrace haven’t forgotten that history but it is important to look back at that history to explain why most companies can ignore certain requirements in the law. That’s right. There are requirements in the law that you can ignore because they will not be enforced by anyone. They are the result of the disjoint way the DQSA was written. Let me explain. Continue reading 3 DSCSA Requirements You Can Totally Ignore
HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain
It has been six years since the Healthcare Distribution Alliance (HDA) updated their full barcode guidelines (see “Updated HDMA Bar Code Guidance: A Must Read”). They just updated it again with major changes over the 2011 version. The new document is called “HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain” and it is available on HDA’s website here. With the passage of the Drug Supply Chain Security Act (DSCSA) in November of 2013, an update was long overdue.
You are forgiven if you thought the HDA updated the barcode guidelines only one year ago Continue reading HDA Guidelines For Bar Coding In The Pharmaceutical Supply Chain
Is Your Drug Too Small For The Mandated 2D Barcode?
RxTrace readers are already well aware that multiple new laws around the world will require prescription drug manufacturers to put a new 2D barcode on their products in the next few years. But what if your drug package is too small to fit the new mandated 2D barcode and human readable information on the label? Let’s take a look at what the regulations say in the E.U., Brazil and the United States. From that, we can come up with some strategies. Continue reading Is Your Drug Too Small For The Mandated 2D Barcode?
DSCSA: Label Artwork Heartaches
One of the surprising things about industry preparations for the Drug Supply Chain Security Act (DSCSA) is how hard it is to make label changes to add the new DSCSA product identifier barcode (see “The DSCSA Product Identifier On Drug Packages”). The artwork changes necessary take a lot longer than everyone originally expected. Companies with hundreds of different drug packages to redesign may have trouble getting all the work done by the November 27, 2017 deadline (2018 for repackagers). If you have thousands of different packages, you had better have a large team working on the artwork changes right now.
What’s the problem? All you need to do is Continue reading DSCSA: Label Artwork Heartaches
FDA Still Receives Requests For Exemptions From 2006 Barcode Rule
This morning the FDA is due to publish an announcement for an opportunity to comment on their proposed collection of certain information as part of ongoing requests for exemptions from the linear “barcode rule” that has been in effect since April 26, 2006. The FDA is soliciting comments on the barcode label requirements for Continue reading FDA Still Receives Requests For Exemptions From 2006 Barcode Rule
The Next Markets To Impose Pharma Serialization and Tracing?
The pharmaceutical markets that currently have a serialization and/or tracing regulation on the books include the United States, the European Union, China, Brazil, India, Italy, Turkey, South Korea, Argentina, Saudi Arabia and Jordan. Not all are fully operational yet, but they are official. This list may be about to grow by two. Continue reading The Next Markets To Impose Pharma Serialization and Tracing?