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 Read the rest of this essay »
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 Read the rest of this essay »
With the enactment of the Drug Supply Chain Security Act of 2013 (DSCSA) last week (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“) I have decided to conduct an annual survey of U.S. pharma traceability preparedness. You can fill out the survey by clicking on this link: Take the 2014 RxTrace U.S. Pharma Traceability Survey Now.
The answers you provide anonymously will be aggregated to provide a view of the thinking of the industry, solution providers, regulators, academics and more, in addition to a view of the preparedness of the industry to meet the new federal pharmaceutical traceability law. Please make sure your company is represented in the data that is collected. The survey is Read the rest of this essay »
On November 27, 2013 President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“). That act has many provisions, but one is to preempt all existing and future state pharmaceutical serialization and pedigree laws like those that previously existed in California and Florida. Because of the preemption language contained within the DQSA, the information contained within many previous RxTrace essays is now obsolete. Some essays are entirely obsolete and some are only partially obsolete. This is because many of these essays contain ideas and discussion about topics that will also apply to the new federal law in almost the same way that they applied to the California and/or other state laws that are now inoperative. In those cases, the ideas and discussion are not obsolete, only their application to the state law(s) is now obsolete.
To address this issue I have Read the rest of this essay »
According to the White House website, President Barack Obama signed H.R. 3204, the Drug Quality and Security Act (DQSA), into law a short time ago, bringing to a successful conclusion efforts by the industry and consumer groups to create a national pharmaceutical serialization and track & trace regulation that eliminates the patchwork of state laws in addition to new regulations for compounding pharmacies.
Many people and organizations contributed to this successful effort and they all deserve congratulations, but I believe the organizations with the most responsibility for this conclusion is the California State legislature and the California Board of Pharmacy in Read the rest of this essay »
If there is one overriding lesson exposed by my essays last week it is that the companies in the U.S. pharmaceutical supply chain must quickly organize to work out technology and process issues that stand in the way of an efficient implementation of phase 1 of Title II of the Drug Quality and Security Act of 2013 (see “DQSA: Getting To Electronic Transaction Data Exchange” and “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”). Title II of the DQSA is the Drug Supply Chain Security Act.
The law gives the FDA one year to publish guidance containing standards for use by companies in the supply chain for the exchange of Read the rest of this essay »
I attended the Healthcare Distribution Management Association (HDMA) Track and Trace Seminar held in Crystal City, VA on November 11-13, 2013. I was particularly interested in the session called “Distributor Case Studies and Updates”, as were a lot of other people. The speakers were:
- Chris J. Anderson, Director, Quality Systems, Cardinal Health, Inc.
- Steve Tadevich, Director, Product Serialization Technologies, McKesson Corporation
- Heather Zenk, PharmD, Vice President, Business Integration, AmerisourceBergen Corporation
Each speaker gave a brief presentation about their current serialization and pedigree programs before taking questions as a panel. As you would expect, all of the preparation these companies have done up to this point has been aimed squarely at the California pedigree law which would have gone into effect for wholesalers in California in mid-2016. But, Read the rest of this essay »
While we wait for President Obama to sign the Drug Quality and Security Act of 2013 (DQSA, a.k.a. H.R. 3204) we can be confident it will become law in the next week or so. This President has been presented with over 740 bills so far in his Presidency and he has signed all but two. He has 10 days to sign the bill or it becomes law anyway but there might be some delay in the process between passage by the Senate and when the President is presented with the bill.
My interest in the DQSA of 2013 is only the Drug Supply Chain Security Act (DSCS) which is Title II within the overall bill. I’m going to keep referring to it as the DQSA of 2013 but be aware that I probably won’t ever write about the compounding part, Title I. If that is what brought you here, sorry, look elsewhere.
It is not law yet, but we can now be 100% sure it will be very soon. Even before the bill was Read the rest of this essay »