Drugs

Drug Distributor National Standards Rule

FDA has published a 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. When finalized, the proposed rule would provide greater assurance that supply chain participants are sufficiently vetted and qualified to distribute prescription drugs, further strengthening the supply chain, FDA says.

In a statement, the agency says the requirements for wholesale drug distributors currently vary significantly across state lines, creating a patchwork system. In passing the Drug Supply Chain Security Act, it says, Congress believed a uniform national standard would address the issue. “This proposed rule would provide clarity and consistency for wholesale distributors and third-party logistics providers seeking licensure,” the statement says. “When final and effective, every U.S. wholesale distributor and third-party logistics facility will be held to these standards. Only those licensed according to the proposed national standards would be able to engage in transactions related to the sale and distribution of certain prescription drugs with other members of the supply chain.”

Provisions for wholesale distributors and third-party logistics providers specifically include licensure application requirements; procedures surrounding pre-licensure inspection and denial, revocation, and suspension of licenses; establishment of standards for the storage and handling of prescription drugs; personnel requirements and qualifications; recordkeeping and document maintenance requirements; and requirements for written policies and procedures.

Once the rule is finalized, FDA says, states and local governments may not establish or continue licensure requirements for third-party logistics providers or wholesale drug distributors unless the state requirements are the same as the federal requirements. FDA also provides standards applicable to, and the requirements for approval of, third-party organizations involved in the licensure and inspection process.

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