FDA's Inaction On Issuing Licensing Rules For Wholesalers and 3PLs Creating Confusion
Agency May Be Forced To Issue Rule Through Litigation, Says Attorney
Highly anticipated proposed rulemaking from the FDA on licensing standards for wholesale distributors and third-party logistics providers has been repeatedly delayed, and the reasons for the delay are unclear. The rule is five years overdue under a DSCSA mandated timeline.
You may also be interested in...
US FDA Commissioner Scott Gottlieb says Congress intended to preempt all state licensure laws that were not identical to federal laws for licensing wholesalers and third-party logistics providers under the Drug Supply Chain Security Act.
US agency's delay in issuing guidance for how it intends to handle un-serialized 'grandfathered' drug products is creating headaches for manufacturers and other parties in the pharmaceutical distribution chain.
FDA draft guidance clarifies the roles of the different supply chain partners under the Drug Supply Chain Security Act. While much attention has focused on the serialization challenges in implementing DSCSA, less attention has been paid to which trading partners are authorized to transfer products.