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US FDA Still “Actively” Drafting Proposed Licensing Rule For Wholesalers and 3PLs

Executive Summary

Pharmaceutical manufacturers should have already begun serializing products and verifying saleable returns to comply with DSCSA, says FDA official who also asserted that licensing standards for wholesale distributors and third-party logistics providers will be forthcoming. This rule is already six years overdue under a DSCSA mandated timeline.

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

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.

Lack Of Readiness In Responding To DSCSA Verification Requests Major Concern

Roughly half of all pharmaceutical manufacturers have misgivings they will have the necessary systems to electronically verify saleable returns under DSCSA, even though they must respond to these requests within 24 hours.

FDA Exempts COVID-19 Prescription Drugs From DSCSA Tracing Requirements

Prescription drugs that are deemed necessary for treating patients in public health emergencies such as COVID-19 would not have to comply with DSCSA tracing requirements, says the FDA. Such drugs would not need to have product identifiers and saleable returns would not have to be verified.

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