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.

Rubber stamping that says 'Licensed'
FDA May Face Court Challenge Over Delay In Issuing Licensing Rules • Source: Shutterstock

The US Food and Drug Administration’s delay in drafting a rule on licensing standards for wholesale distributors and third-party logistics providers required by the Drug Supply Chain and Security Act is allowing states to create a confusing array of their own licensing rules.

Tish Eggleston Pahl, a principal attorney with the Washington food and drug law firm Olsson, Frank Weeda Terman Matz who...

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