§360eee–2 National standards for prescription drug wholesale distributors

Summary

The Secretary must make national rules for licensing people who wholesale prescription drugs. The rules had to be made no later than 2 years after November 27, 2013, and they apply to all State and Federal wholesale distributor licenses. The rules must cover storage and handling (including facility needs), keeping records of drug distributions, and financial security: non-government wholesalers must post a surety bond of $100,000 for a license or renewal, but a State may accept $25,000 if the wholesaler’s prior-year gross receipts were $10,000,000 or less. If a wholesaler shows it has the required bond in one State, other States may waive the bond. The rules must also require background checks and fingerprints for facility managers or designated reps, set qualifications for key staff, and require a physical inspection of the facility soon after the initial application. Inspections may be done by the federal or State licensing authority, the State where the facility is, or an approved third-party inspector. The rules must bar people convicted of certain felonies related to distribution or product tampering, or people who repeatedly break licensing rules in ways that risk serious harm or death. When making the rules, the Secretary must publish the proposed rule with a copy, allow at least 60 days for comments, and have the final rule take effect two years after it is published.