FDA Delays Implementation of Serialization for Pharma Manufacturers

Working on a tight deadline is nothing new for many people, but occasionally you catch a break. It’s always a nice feeling when a deadline gets extended at work. Now, imagine that mental sigh of relief multiplied a thousand-fold.

That’s what happened when the FDA decided to delay for one full year the implementation of the Drug Supply Chain Security Act, or DSCSA. Pharma manufacturers caught a big break with the announcement, even though the DSCSA was originally announced back in 2013.

So, what’s the big deal? Well, the DSCSA will require all prescription drugs in the U.S. to come with a serial number. The serialization will help to fight counterfeit drugs and prevent product diversion. That sounds reasonable when you first hear it, but it’s caused some major consternation for pharma manufacturers. In many cases for the first time, supply chain partners have to manage serialization and work with a serialized product inventory. That’s a much bigger burden than one might think.

In fact, many of the smaller manufacturers and companies were the impetus behind the one-year delay. They told the FDA that they quite simply wouldn’t be able to implement serialization by the looming deadline of November 27, 2017.

So, the FDA has relented and allowed a one-year delay. However, that’s just a one-year delay in assessing penalties for non-compliance with the act. The original deadline is still in place according to the law, so manufacturers must begin serialization this November, but the law won’t be enforced for another year.

Wondering how serialization works? The FDA released guidance on what would be required of manufacturers. The first stipulation is that prescription drug packages and cases must all have a unique identification as they move through the supply chain. This allows any trading partners to trace the drugs back to their origin at any time. That identification must include a lot number, a national drug code, an expiration date, and of course, a serial number.

Because these unique IDs can be traced by both humans and machines, it helps to ensure that all supply chain partners can detect illegitimate drugs as they move through the supply chain. The World Health Organization estimates that the pharma industry loses almost $40 billion a year to counterfeit prescription drugs. While the initial cost of serialization may seem heavy to manufacturers, the law will likely save them money over the long-term.

The yearlong delay is also part of the effort to help manufacturers focus on long-term solutions, rather than looking for a quick fix to become compliant before the deadline.

At Lifecycle Biotechnologies, we know how important it is that patients and care providers get only high quality and reliable medication. We don’t manufacture those medicines, but we partner with those who do, and it’s just as important that those manufacturers and research labs have quality products that they can rely on. Contact us today to find out more about how Lifecycle can benefit your business.