Following suit from California, two new states have introduced legislation aimed at 3PL licensing requirements for handling and storing pharmaceutical products. These statewide requirements are additional (and contradictory) to the federal requirements outlined in the Drug Supply Chain Security Act (DSCSA).
The Pharmaceutical Distribution Security Alliance (PDSA), of which IWLA is a member, issued comments in response to SB39 and highlighted several inconsistencies related to terminology and requirements.
According to the PDSA, Louisiana’s SB39 “Establishes licensing authority for all ‘distributors,’ which includes all sectors of the supply chain—manufacturers, repackagers, wholesalers, 3PLs, and dispensers. The apparent intent is to establish state licensing authority for all sectors, but actual licenses would be tailored to each sector (or possibly even sub-sectors, such as specific types of manufacturers).”
The Oregon Board of Pharmacy’s Drug Distribution Agent Amendments “Direct third-party logistics providers to register as a Drug Distribution Agent. As a drug distribution agent, the 3PL must establish and maintain pedigree information which is defined as the transaction history.”
As in California, the state programs are counterproductive to attaining the initial goal of DSCSA: to set a standardized process for handling pharmaceuticals and tracking information as the products move through the supply chain. These legislations also group 3PLs into the larger “distributor” category, whereas the federal program differentiates requirements based on the various roles: manufacturer, distributor, dispenser, etc.
IWLA will continue to fight these programs through official comments and by creating a unified voice of the pharmaceutical supply chain via the PDSA. Stay tuned for new developments.