Serialization Challenges for Wholesalers and Re-packagers

The Drug Supply Chain Security Act (DSCSA) outlines detailed steps to build an electronic, interoperable system to identify and trace various prescription drugs, to be distributed in the United States. This will not only help FDA increase its ability to help protect consumers from stolen, contaminated, counterfeit, or harmful drugs by improving the traceability, but also help FDA to establish national standards for wholesale distributors, and third-party logistics providers. Under DSCSA, wholesale distributors, and third-party logistics providers must report licensure, and other related information to FDA annually.
As time comes close, many of the wholesalers and repackages have started preparing for DSCSA Law of Serialization. Many of us have already started a step towards compliance, but see many challenges ahead, as we approach the compliance deadline of November, 2018 and 2019.
In this short article, I wanted to share my view on the challenges we face, based on my personal observation:

Cost:
This marks as one of the biggest challenges for the compliance, especially for the small firms acting as re-packagers. Building a serialization solution does not come cheap. Costs associated include evaluating various vendors and purchasing a solution, purchasing updated equipment, co-ordinate with various parties, implementation and maintenance thereof. Not to forget, many of the companies do not have any experience in the serialization implementation, and hence, they need to consult someone, who can guide them in the right direction and lead them to successful compliance. Because of the scarcity of the experts in this evolving field, costs associated are not cheap. For the small wholesalers, and re-packagers, this sums up to an amount they need to think over about, and as the time comes to close, these costs only keep on increasing because of the deadline, and scarcity of solutions and experts.

Vendor Selection:
There are a few many solutions available in the market that help companies in implementing serialization. Majority of the companies we have worked with, are not sure which solution is the right fit, and hence, have to go through a detailed evaluation process. This takes time, effort, and hence, adds costs, and pressure for the timely implementation of serialization.

Process Change:
Implementing serialization means process change. This will completely change the way the companies, including wholesalers, and re-packagers have been packaging, re-packaging, and tracing the products. This implementation will require a new work flow, and probably more man power to label the products. This also means that the companies will have to provide training and re-training to their employees, as new changes are to be introduced in the upcoming years.

Outdated Equipment:
Many of the companies run on legacy softwares and equipment. Serialization compliance requires updated equipment and software to improve the traceability of their products. Companies now will have to retire their legacy equipment, software, and this leads to process and work flow changes, and will require training the employees.

Increased Documentation:
Until now, the pharmaceutical companies, including re-packagers and wholesalers, were not required to trace the product from start to end by law. Serialization will put an end to this. The companies, now, will have to trace their products from the moment they manufacture it, to the time it gets to a consumer. This means, they are required to document this entire process, at each step electronically.

On-Going Maintenance:
How to run the system, and how to maintain the records in long run, is also a challenge for various companies. Not all the companies are involved in the process from start to finish, and this means, they will have to co-ordinate with and depend on other companies, TPAs, to tracing their products. Getting everyone on the same board, in the limited amount of time is definitely challenging.

Again, these are only a few of the biggest challenges faced by companies going through the process of serialization. Every company has a set of their own challenges, depending on their own size, the type of company it is, packaging facility and the manpower they have, and depending on where they are in terms of compliance. We will discuss more on the serialization very soon. Stay tuned for more!