Coding for Compliance
This blog is a central resource for coding and pharmaceutical compliance issues. After 20 years in the market, I appreciate the challenge of gathering information and finding a forum to discuss key issues. I developed this blog to support these efforts in the pharmaceutical industry. Let’s start a dialogue.
Pharmaceutical Business Development Manager, Domino
Domino is thrilled to attend the International Pharmaceutical Expo (INTERPHEX), the leading pharmaceutical and bio-pharmaceutical manufacturing trade show in the U.S. Why is this event a great fit for Domino? Because the Drug Quality and Security Act (DQSA) has been passed, it is important for industry professionals to get their serialization questions answered and ACT […]
As a result of DQSA, many are facing compliance challenges such as lack of qualified vendors, limited vendor bandwidth and time consuming implementation. Domino developed streamlined serialization solutions to be demonstrated live on the floor at INTERPHEX March 18-20, 2014 at the Javits Center in New York City. Catch the action at Booth #2725! Domino Amjet […]
Since the World Health Organization recognized the problem of counterfeit pharmaceuticals 40 years ago, the industry has waged a constant battle against sophisticated counterfeiters, with drug packaging as its foremost defense. The U.S. has passed legislation, increasing efforts to combat counterfeiters, while other countries have developed their own serialization initiatives. A fundamental premise for all […]
A recent survey conducted by Healthcare Packaging in late 2013, found serialization was the top concern among combination product manufacturers. Creative medical treatment advances including the combinations of biologics, medical devices and/or pharmaceuticals have been in development for over 20 years, and now, they’re seeking guidance in packaging and regulatory issues.
The Drug Quality and Security Act (DQSA) preempted all existing and future state pharmaceutical pedigree and serialization laws. So what does this mean for all the research and planning many have put into compliance at the state level?
Selecting and collaborating with valuable, trusted partners will be a hot topic and primary objective for many pharmaceutical companies in 2014 as they prepare for the unique challenges that come with serialization. Domino Printing Sciences and Weiler Labeling Systems have been collaborating for more than eight years to effectively combine their unique strengths and offer […]
There was a lot of speculation over serialization in 2013 prior to President Obama signing the Drug Quality and Security Act (DQSA), making it one of the hottest topics circulating the Pharmaceutical industry last year. This article by Jim Butschli from Healthcare Packaging titled Top 10 Healthcare Packaging Stories from 2013, provides an overview of […]
Wondering what technology is appropriate for your packaging? Looking to explain the serialization challenge to others in your company? Our new video can help!
In the wake of the U.S. Congress decision to pass the Drug Quality and Security Act (DQSA), Domino North America will stationed at INTERPHEX to answer questions about the new legislation and showcase latest product developments.
As you may know, the US Congress has been trying in vain for many years to draft comprehensive drug legislation, with a track-and trace-component, that would create a comprehensive federal law applying to all of the US and superseding all state mandates (including California e-Pedigree). This has gone on for years with little success. All of […]
Many companies in the health care industry are well into the process of implementing various components or complete serialization programs. Many are not. Why not? Some of the common responses we hear regarding why companies are not yet moving forward with a serialization initiative are as follows…
Acsis, a valuable partner of Domino and leading provider of Enterprise Serialization Solutions, knows exactly what’s involved with E-pedigree compliance.