Make Your Mark in Item Identification Standards

With a two-year extension in meeting California 's electronic pedigree rules, you may be tempted to postpone your serialization efforts for a while. You do have more time now to revisit your options, but start planning your programs as soon as you can.

In the meantime, you have two more-pressing deadlines to meet next month. FDA has asked for your comments on standards and technology  for drug identification. At issue are standards for numerical identifiers as well as track and trace or authentication technologies. You have until May 19 to weigh in on both.

Health and Human Services Secretary Michael O. Leavitt is charged with developing a “standardized numerical identifier to be applied to a prescription drug at the point of manufacturing and repackaging (in which case the numerical identifier shall be linked to the numerical identifier applied at the point of manufacturing) at the package or pallet level, sufficient to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug.” He also has to develop standards addressing “radio-frequency identification, nanotechnology, encryption technologies, and other track and trace or authentication technologies.” All by March 2010. Ideally, the numerical identifier standard would be harmonized with international consensus standards.

Do not miss your chance to comment. At every California State Board of Pharmacy (BoP) Pedigree Enforcement Committee meeting I've attended, drug companies have decried the lack of standards and scant FDA guidance. You now have your chance to share your concerns.

Some stakeholders may be reluctant to speak up. It may almost feel like asking for more regulations and responsibilities. But FDA needs answers to some pretty important questions. For instance, “Should the standardized numerical identifier contain recognizable characteristics (e.g., National Drug Code number) or be random codes?” the agency asks. There is interest in using the global trade item number (GTIN), specifically the serialized global trade item number (SGTIN) without an embedded NDC in the GTIN. Would that work for your company?

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