The pharma supply chain—from manufacturers to pharmacies and health systems—is in Year 6 of a 10-year march to full compliance with the US Drug Supply Chain Security Act (DSCSA). And while a number of intermediate milestones have been met, there are upcoming deadlines that will require close coordination among trading partners and service providers by the final 2023 deadline. On that date, the supply chain is supposed to have electronic tracking of pharmaceuticals, at the unit level, wherever they might travel.
For the past couple years, as the coordination need has become clearer, there have been repeated calls for a governance function of how compliance will be effected. Earlier this year, a proposal was floated by parties involved with an earlier effort—the Pharmaceutical Distribution Security Alliance—to set up such a body. Now, according to sources close to the effort, sufficient industry participation has occurred to make the as-yet-unnamed group a reality.
Key to the effort is getting cross-supply-chain participation. Some 20 manufacturers have signed on, as well as several heath systems, at least one chain pharmacy, and several trade associations. A governing board is being set up, but staffing and budgeting remain to be determined. The effort got a boost when FDA agreed to include the effort as part of the DSCSA pilot program announced last spring. That pilot program—itself part of the DSCSA legislation—involved voluntary participation; 20 pilot programs are currently underway. Both to meet the timeframe of the pilot program (which is supposed to wrap up early next year) and to begin to resolve a host of collaboration issues before regulatory deadlines are passed, there was a need to get the governance effort off the ground now.