Think of the technology you used 15 years ago. Now, think of the technology you use today.
With that in mind, think about what technology will be available in seven years.
"We don't want to be solving 2001's problem when we are in 2023," said Bob Celeste, Founding Partner of RC Partners, at the Pharmaceutical Traceability Form in Philadelphia.
It's just one example of why the Drug Supply Chain Security Act can become so complicated. Although it gave the pharmaceutical industry a number of years, including extensions, to become compliant, it didn't spell out exactly how to do it.
"There are a lot of nuances in the law," he explained. "No one knew what technology would be available when it was written."
As new technologies become available in labeling, printing, machinery and automation, the law will have to be flexible to accommodate them.
For example, he explained there is a lot of experimentation going on with barcodes. This can include where to place them on the package, what they should look like, how they will be read—the list of variables goes on and on. There is no one cut-and-dried solution.
Information sharing
The DSCSA demands accuracy. At each phase of the process, the data has to match what is in the cartons—and has to be readily available.
This can become difficult, especially when dealing with a complex pharmaceutical supply chain.
"How do I establish trust with everyone else almost on the fly," Celeste said. "I'm not going to have a connection with 35,000 manufacturers. But yet, I need to be able to get that information if the California, or Nevada board of pharmacy walks in and asks for that information."
This is one of the ways automation can help, but there are a number of concerns and issues with that as well.
"How do our [network] systems work out legitimate problems," he asked? "Our systems will have to be able to talk to each other. They will have to be able to establish trust, and share. My system will have to be able to ask your system a question. I need to find you, establish trust and ask you questions about what has occurred."
The FDA's influence
So, what's the FDA saying about all of this? Well, it's really not.
They are holding pilot programs as different parts of the DSCSA rollout. But, they are being very careful not to make more problems, or introduce additional terms and rules.
"It is giving the FDA an opportunity to look at where everything is and pause, and say, 'where are we, what are we doing, how far are we?'"
