FDA to Speak at Upcoming U Connect Conference

Dennis Baker, Regional Food and Drug Director, FDA’s Southwest Region, will speak about the agency’s efforts to improve the supply chain during a keynote address on June 9 during the upcoming U Connect Conference. Hosted by GS1 US and its conference partner VICS, the event will cover standards-based business processes and best practices for managing the supply chain efficiently.

FDA has several initiatives underway that involve supply-chain safety. Most recently, the agency issued its final guidance, “Standards for Securing the Drug Supply Chain—Standardized Numerical Identification (SNI) for Prescription Drug Packages.” The document describes its advised SNI, the serialized National Drug Code (sNDC). Under that system, a unique serial number with up to 20 alphanumeric characters would join the NDC. While FDA has not specified the data carrier(s) that could be used to carry this sNDC, the agency believes that both 2-D bar codes and RFID could be used.

FDA notes that its SNI may be presented within a Global Trade Item Number (GTIN), “which can be serialized using an Application Identifier (AI) (21) to create a serialized GTIN (sGTIN) for use with RFID or for certain bar codes,” the agency explained in its guidance. The GTIN was “established by GS1. FDA has been an active observer and participant in GS1 standards development related to healthcare and drug products. According to documentation from GS1, the GTIN is used worldwide by twenty-three industry sectors, including healthcare, and has been adopted by sixty-five countries to uniquely identify pharmaceutical products.” Compliance with the GTIN standard enables FDA to fulfill its mandate under the Federal Food, Drug, and Cosmetic Act (the Act) regarding development of an SMI harmonized with international consensus standards.

FDA is also tackling other supply-chain challenges, such as curbing cargo and warehouse thefts. The agency has issued “20 public alerts since April 2009,” said Ilisa Bernstein, director of pharmacy affairs in FDA’s Office of the Commissioner, Office of Policy, in an April 28 conference call with industry stakeholders. These alerts pertain only to domestic incidents.

PMP News asked whether use of the sNDC could identify stolen products better than lot numbers. “Use of a serialized NDC will be very helpful in better identifying stolen products that make their way back into the supply chain,” FDA spokespeople explained to PMP News.

GS1 US looks forward to sharing FDA’s perspective at U Connect. “We’re very pleased to have FDA representation at the U Connect Conference. GS1 US is a central element in multiple industries’ efforts to improve product tracing, which is an FDA objective as well, so there’s an important connection being made here for our attendees,” Jon Mellor, GS1 US,  Director, External Affairs. “They will benefit from hearing directly from FDA.”

U Connect will feature a number of sessions intended to provide attendees with healthcare supply chain analysis and perspective. The “Healthcare Focus Session: The Impact of FDA and State Drug and Medical Device Regulations on the Supply Chain” will be held June 08.

The event will be held at the JW Marriott San Antonio Hill Country Resort, beginning June 7 with pre-conference seminars. The main conference begins June 8. Exhibits will be open Monday through Wednesday. To register, use UCON10-PMPN for a 10% discount and click here.

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