Third party logistic providers may encounter new difficulties in an already complex regulatory landscape
Third party logistic providers (3PLs) that facilitate warehousing, shipping and other logistic services for pharmaceutical manufacturers or wholesale distributors have likely grown accustomed to the rigorous demands of a tightly-regulated industry. But according to a recent installment of Wolters Kluwer CT Corporation’s Expert Insights podcast, 3PLs already struggling to contend with a multitude of state regulations could find their compliance burden intensifying in the face of a proposed rule announced by the U.S. Food and Drug Administration earlier this year.
Hans Howk, Manager of Content Management at Wolters Kluwer CT Corporation, explains that most states maintain some variation on a third party logistics license, with 3PLs forced to track and comply with a complex web of requirements spanning each state in which they do business. Depending on the jurisdiction involved, 3PLs may be asked to provide a wide range of materials that includes contract samples, customer states, proof of general liability insurance or the names and addresses of all partners and major shareholders.
To bring some consistency to the landscape, the FDA announced a proposed rule in February designed to ensure that all states are regulating the drug supply chain in a strict and unified manner – but Howk suggests that this may ultimately tighten regulations for pharmaceutical companies and 3PLs alike. He recommends that 3PLs engage the services of a trusted partner who can track evolving regulations, submit license applications, and execute pending renewals.
“Engaging the services of a trusted partner such as CT Corporation to centralize and manage these processes allows third party license providers to focus on running their business,” Howk said.