Drug and pharmaceutical warehouses must be prepared for pharmaceutical serialization to comply with FDA regulations by November 2017.
The highly regulated pharmaceutical supply chain continues to grow in complexity. But pharmaceutical serialization regulations can require more than commercial off-the-shelf software (COTS) can deliver. In Part 1 of a series, we begin with a quick primer on the US Drug Supply Chain Security Act.
What is the Drug Supply Chain Security Act?
The objective is to provide the capacity to confirm the validity, legitimacy, and source of all applicable products within the pharmaceutical supply chain in real time.
The Drug Supply Chain Security Act requires manufacturers to affix a scannable product identifier to all compounded drugs that are packaged for pharmaceutical use. The objective is to provide the capacity to confirm the validity, legitimacy, and source of all applicable products within the pharmaceutical supply chain in real time. Partners in the supply chain must be able to provide information of any given product within 24 or 48 hours, as well as notify the FDA and all relevant authorized partners of any problems or instances of contamination.
The bill states that, “Beginning not later than January 1, 2015, the trading partners of [manufacturers, wholesale distributers, repackagers and dispensers] may be only authorized trading partners.” Manufacturers, repackagers, wholesalers, and dispensers were supposed to begin capturing and storing the transaction history for all applicable packages for six years after the transaction effective January 1, 2015.
For each transaction in which a manufacturer transfers ownership of a product, they must pass along that product’s transaction history, transaction information—including lot-level information—and a transaction statement, all within a single document. It is this document that must be stored. The document can be in paper form for the time being, but must be fully electronic within 10 years.
Why was the Drug Supply Chain Security Act Created?
The new regulations are in response to a fungal meningitis outbreak that took investigators years to trace back to three lots of bad chemicals produced at the New England Compounding Center’s facility in Framingham, MA. These compromised chemicals were distributed in 75 medical facilities across 23 states and were administered to nearly 14,000 individuals before the CDC and FDA were finally able to identify and sequester the contaminated products. To date there have been over 750 cases of infection and more than 60 deaths. Yet such an investigation would have taken substantially less time under the new track-and-trace regulations.
It is worth noting that this is not the first instance of a procedural failure necessitated by the need to quickly find and properly quarantine contaminated products, although it has sparked the creation of uniform regulations among all 50 states. The regulations set forth in the Drug Supply Chain Security Act are designed to allow the FDA to find and quarantine suspect or compromised packages and prevent fraudulent ones from entering the pharmaceutical supply chain.
The reason this meningitis outbreak was so terrifying was because there was no easy way to determine the source of the problem. This was due to the fact that the NECC was exempted from FDA management in 1998 by local officials, allowing the company to operate as a drug manufacturer while not having to register as a manufacturer. The NECC’s practice of synthesizing large batches of drugs in one state and then shipping them to another would be considered manufacturing by FDA standards. This means that any product coming from the NECC facility wasn’t FDA approved, so the organization was not obligated to file an incident report when a problem was found and product quarantine became necessary.
Now is the Time to Add Pharmaceutical Serialization Capability
2D Data Matrix barcodes are specifically mandated by the US Drug Supply Chain Security Act.
The Drug Supply Chain Security Act implements a FDA regulated nationwide track-and-trace system that will require manufacturers to affix a scannable product identifier to each package or homogenous case of pharmaceutical product. While the bill defines, “the term transaction history [as] a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product,” it also mandates that this information, “…shall be included in a 2D data matrix barcode when affixed to, or imprinted on, a package or a homogeneous case.”
The end goal is to have a lot-level serialized data matrix that will allow for easy track-and-trace down to the individual product level. Though the compliance dates have changed, and are subject to change again, at the moment:
- Manufacturers must serialize by November 2017
- Repackagers must serialize, and accept only serialized drugs, by November 2018
- Wholesale Distributors must accept only serialized drugs starting November 2019
- Dispensers / pharmacies must have begun using either paper or electronic traceability by July 2015, and use completely electronic documentation within 10 years. They also must accept only serialized drugs starting November 2020.
Get Started on Your 2D Barcode Integration and Serialization Project
Want to learn more? Catch Up on Our Latest Success which supplied MD Logistics with custom systems and optimized barcode integration to satisfy all new regulations before the compliance deadline.
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