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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

Executive Summary

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.

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