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More serialization options, especially for low-volume pharma manufacturers struggling with the November 2017 deadline
Woodfield Distribution has a growing business as a third-party logistics provider (3PL) for pharma manufacturers, operating out of an expanded distribution center in Boca Raton, FL. Now, in what it says is a first for the pharma industry, the facility can also provide serialization services to meet the November 2017 deadline for compliance with the Drug Supply Chain Security Act (DSCSA) which, among many other things, requires a unique serial code on each package of commercially distributed product after that date. While most major manufacturers are well along with their serialization programs, smaller manufacturers with either a limited number of products, or a product volume too small to economically justify installing a DSCSA-compliant packaging line, now have another option.
Many of these smaller manufacturers typically work with a contract manufacturing organization (CMO) to handle packaging and serialization, but that can present operational problems, says Larry Hotz, chief marketing officer at Woodfield. “The brand owner is ultimately responsible for the disposition of the serial codes, and to convey those codes to trading partners,” he says. “Unless the CMO and brand owner have worked this out carefully, DSCSA compliance will be a multi-step, overly complicated process.” Hotz says that Woodfield has chosen TraceLink as its serialization-management solution, and will set up a cloud-based data repository under the control of the brand owner. In effect, Woodfield is not only providing serialization, but also managing the trading-partner data transfers that will be part of later DSCSA compliance requirements.
Woodfield Distribution has a sister company, Woodfield Pharmaceutical, that is a full-blown CMO, and has an installed serialization system in place there. That CMO competes with many other CMOs in providing packaging and serialization services; the company can package plastic and glass bottles, nasal spray devices and tubes, and provide secondary cartoning, tray and shrink-wrap packaging. By incorporating a serialization service in the 3PL part of the company, Woodfield hopes to provide a more flexible option for its distribution clients. Most of Woodfield’s current business is in US 3PL services, but Hotz says that the company is looking ahead to providing its service to exporters from the US as well.