FDA Issues Proposed Standard for 3PL Licensing

After years of delay, the US Food and Drug Administration (FDA) has announced the availability of the proposed rule National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers as required by the Drug Supply Chain Security Act (DSCSA). The proposed rule, when finalized, will provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain. The proposed rule does not apply to over-the-counter medications or to medical devices.

IWLA and its members met repeatedly with FDA officials during the development of the  proposed rule. The proposed rule will provide clarity and consistency for third-party logistics providers seeking licensure. When final and effective, every third-party logistics facility will be held to these standards. Only those licensed according to the proposed national standards will be able to engage in transactions related to the distribution of certain prescription drugs with other members of the supply chain. Where a state does not have a licensing program in accordance with the regulation, FDA will be the licensing authority. 

Provisions for third-party logistics providers specifically include:

Licensure application requirements.

Procedures surrounding pre-licensure inspection as well as denial, revocation, and suspension of licenses.

Establishment of standards for the storage and handling of prescription drugs, including facility requirements and security, inventory management, and equipment maintenance.

Personnel requirements and qualifications.

Recordkeeping and document maintenance requirements.

Requirements for written policies and procedures.

A key provision advocated by IWLA and in the proposed rule includes FDA’s revised preemption interpretation that will apply to state and local licensure standards, requirements, and regulations. Once the proposed rule is finalized and effective, under this interpretation, states and local governments may not establish or continue licensure requirements for third party logistics providers or wholesale drug distributors unless those state requirements are the same as federal requirements.

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