§360eee–2 National Standards for Prescription Drug Wholesale Distributors

Summary

The Secretary must make national rules for licensing prescription drug wholesale distributors no later than two years after November 27, 2013. The rules apply to both State and Federal licenses. They must say how drugs are stored and handled, how distribution records are kept, what security is needed (normally a bond of $100,000, or $25,000 if the wholesaler had $10,000,000 or less in annual gross receipts last year), that a bond held in one State can waive the bond in another State, that facility managers or designated reps must have background checks and fingerprints, what qualifications key staff need, and that facilities must have a physical inspection before licensing. Inspections can be done by the federal or State licensing authority, the State where the facility is, or an approved third-party inspector. The rules must block licensure for people convicted of certain felonies related to wholesale distribution, specific federal food-and-drug or product-tampering felonies, or for those who repeatedly break licensing rules in a way that risks serious harm or death. The Secretary must publish a proposed rule, allow at least 60 days for public comment, and make the final rule effective two years after it is published.