FDA Proposal for 3PL Licensure Standards
The U.S. Food and Drug Administration may soon publish proposed licensure standards for third-party logistics providers (3PLs) and wholesale distributors. The proposed standards are currently under review by the White House Office of Management and Budget (OMB). Last month, several IWLA members met with OMB and FDA officials to discuss licensing issues, including the confusion that exists over conflicting state licensure requirements.
The rulemaking is required by the Drug Supply Chain Security Act (DSCSA). The rulemaking, once finalized, will establish standards for state licensing of prescription drug wholesale distributors and 3PLs. The rulemaking will also establish a federal system for wholesale drug distributor and 3PL licensing for use in the absence of a state licensure program.
The DSCSA licensing standards for 3PLs will apply to any entity that provides or coordinates warehousing, or other logistics services, for prescription drugs in finished dosage form for administration to a patient without further manufacturing. The DSCSA requirements are not applicable either to OTC products or to prescription medical devices.
For additional information regarding DSCSA and 3PL licensure requirements, contact IWLA’s Washington Representative, Pat O’Connor, at firstname.lastname@example.org.
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