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FDA's Inaction On Issuing Licensing Rules For Wholesalers and 3PLs Creating Confusion

Agency May Be Forced To Issue Rule Through Litigation, Says Attorney

 
• By Joanne S. Eglovitch

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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