MedCity Influencers, Pharma

Track and trace is on the way. Is your drug supply chain ready?

Starting this November, all pharmaceutical companies selling prescription drug products in the U.S. will be required to serialize each individual, saleable drug unit. Here's how to get your supply chain ready.

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U.S. drug manufacturers with products in late-stage clinical trials and on the path to FDA approval may be overlooking an important consideration: preparing for serialization.

Starting this November, all pharmaceutical companies selling prescription drug products in the U.S. will be required to serialize each individual, saleable drug unit. More specifically, shipping these regulated products will be prohibited without a National Drug Code (NDC), serial number, lot number, and expiration date in both machine-readable and human-readable format, thanks to the 2013 Drug Supply Chain Security Act (DSCSA), enacted to protect the supply chain from counterfeit medicines.

No company in late stage clinical trials wants to be caught unawares and non-compliant, when FDA approval of a drug or therapy is granted. So what do these companies need to know about supply chain compliance, and how can they properly prepare to meet serialization regulations on the horizon? Here are some basics about DSCSA and four ways for drug manufacturers to minimize risk and maintain their hard-earned momentum after the FDA gives the green light.

How drug manufacturers will meet compliance
The core concept behind DSCSA is to develop and maintain a tracking system from the manufacturing floor through point-of-sale, capable of 100 percent accuracy. Companies at the Phase 3 clinical trial stage have no DSCSA requirements. But as soon as a drug product goes to market in the U.S., the manufacturer is the first in line to comply by the November 2017 deadline with serialization, verification, and data exchange and storage guidelines. Specifically:

Serialization

  • Serialize at the package level, using a 2D DataMatrix barcode.
  • Serialize at the sealed homogeneous case level, using a 2D DataMatrix or linear barcode.
  • Set up data to be machine- and human-readable and include an NDC, serial number, lot number, and expiration date.

Data exchange and storage

  • Provide transaction data to trading partners in electronic format only. The Transaction Data (TD) set includes Transaction Information (TI), Transaction History (TH) and Transaction Statement (TS), collectively referred to as T3.
  • Store serialization data in an active, readily available location for six years past the transaction date.

Verification

  • Respond to verification requests from authorized wholesalers, re-packagers, and/or dispensers within 24 hours.
  • Verify the unique product identifier of suspect products at the unit of sale level. 
  • Verify the unique product identifier of returned products intended for resale.

How companies in late-stage clinical trials can minimize risk
When it comes to planning for serialization, delay is no longer an option. If drug manufacturers don’t serialize in a serialized world, they won’t be able to bring their products to market. And the last thing any company needs, after investing considerable time and money into research and development, is to be held up by DSCSA compliance. Staying mindful of these four considerations can help pave the way for a successful product launch:

  1.  Identify partners and open up lines of communication.

Many companies in Phase 3 are looking to external parties to do the manufacturing, packaging, and shipping of their product. Contract manufacturers (CMOs), packagers, and third-party logistics (3PL) providers all play a role in commercializing product. Now with DSCSA, all these players are required to exchange serialization data. Even a company that works with only one CMO (for scaling and packaging the drug) and one 3PL (for shipping serialized product out to the customer) will have to consider how that data exchange will transpire. So for any company in Phase 3, it’s not too early to get the dialogue going with partners to determine a workable system. Because without the capability of connecting to their CMO or 3PL, drug producers simply will not see their product come to market.

  1.  Understand how serialization will impact operations.

While manufacturers already print lot and date codes on each unit of sale, the reality of serialization goes far beyond printing and labeling a few more attributes. Preparing for serialization and managing continuous compliance impacts every functional area across a company, including manufacturing, IT, quality assurance, supply planning, and regulatory operations. Companies that internally produce and package their drug face even more complexities with serialization integration. But whether production is in-house or outsourced, companies are going to have to operate differently in a serialized world.

  1. Know that the right serialization solution is critical to success.

Serialization is a beast that impacts many different operations in a manufacturing plant and downstream, as well, and introduces unprecedented challenges in data exchange and storage. Therefore, one of the most critical decisions a company will make is its serialization infrastructure solution. Simply put, the best solution is one that minimizes risk. What does that model look like? For starters, it has a proven approach to life sciences compliance. It leverages industry standards such as EPCIS, but is flexible enough to accommodate non-standard requirements without costly customizations. What’s more, it enables connectivity with a company’s chosen CMO, 3PL, and also its wholesaler (who may have an entirely unique set of requirements and standards to be met), in order to facilitate interoperability and properly pave the way for serialization to be an efficient and effective component of product delivery and an enabler to long-term success.  

  1.  Accept that serialization readiness will take longer than expected.

If product isn’t serialized when FDA approval is granted, days can turn into weeks, and weeks into months before a pharma company is serialization-ready. The way around that is for companies to start strategizing now about serialization readiness, opening up discussions with contract partner prospects, and exploring serialization infrastructure solutions. Even companies that won’t have a product ready to market this November would be wise to start preparing. Many of them are doing just that. According to results of a poll from a recent TraceLink webinar, The DSCSA Journey: A Day in the Life of a Serial Number, nine out of ten companies in Phase 3 are currently researching, designing, or actively deploying their serialization program. Because they understand that once FDA approval comes, they don’t have a day to spare bringing their drug product to market.

DSCSA has stimulated a new market in track and trace technology, and there are large financial obligations for companies in the supply chain to come into compliance. Even for companies that have yet to bring their product to market, it’s not too soon to start paving the way for serialization.

Photo: shutter_m, Getty Images


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Dan Walles

Dan Walles is VP of Global Solutions at TraceLink, where he brings to his role more than 20 years of experience in product management, solution consulting, and service delivery. He has focused exclusively on the needs of the life sciences industry for the past 15 years. Since joining TraceLink in 2010, Walles has been instrumental in educating customers on TraceLink’s Life Sciences Cloud and partner ecosystem to enable compliance and added business value through supply chain visibility and improved patient outcomes. @dwalles @TraceLink

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