This Tuesday, the California State Board of Pharmacy decided to delay the implementation of electronic pedigree requirements for prescription drugs from the previous 2009 deadline to 2011. The state’s announcement carries some added significance at a national level; under direction from the FDA, other states like Florida and Utah have moved forward with similar pedigree rules as a means to thwart counterfeiting, but California’s e-pedigree legislation — and particularly the requirement to serialize all packaged items of prescription drugs sold within the state — is the most comprehensive and far-reaching to date. Companies at every stage in the pharmaceutical supply chain (e.g. manufacturers, distributors, and pharmacies) as well as other stakeholders (e.g. technology firms, standards organizations, other regulatory bodies, etc.) have been keeping tabs on California’s industry-leading legislation and enforcement timeline with keen interest.

Forrester sees the implementation delay as being inevitable. California’s serialization rule requires that each sellable unit of prescription drugs must have a unique identification number established at the point of manufacture. Then, as these items are distributed throughout the pharma supply chain, ePedigree requires information on the packaging hierarchy (i.e. which items are packed in each case) and master data context (i.e. original batch, lot, expiration, and NDC data), and change of ownership (i.e. shipping and receiving transactions) must be is captured electronically by each trading partner through an interoperable system. It’s by no means simple, and two fundamental questions have remained largely unresolved, and are thus standing in the way of pharma companies agreeing on a consensus technology approach:

Which tagging technology should be used?