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

Summary

The Secretary must create rules for licensing prescription drug wholesale distributors no later than 2 years after November 27, 2013 (by November 27, 2015). The rules must apply to all State and Federal licenses described under section 353(e)(1). They must cover how drugs are stored and handled, what records of drug distribution must be kept, bond or other security to get or renew a license (usually $100,000, or $25,000 if the wholesaler had $10,000,000 or less in gross receipts the prior year), fingerprint and background checks for facility managers or reps, qualifications for key staff, and required physical inspections of facilities soon after the initial application. If a distributor already has an accepted bond in one State, other States may waive a second bond. The rules must bar people from getting or keeping a wholesale license if they were convicted of a felony related to wholesale distribution, a felony violating subsection (i) or (k) of section 331, or a felony under 18 U.S.C. 1365 (product tampering), or if they have a pattern of serious violations that could cause death or serious harm. In making the rules, the Secretary must publish a proposed rule with the text, allow at least 60 days for public comment, and set the final rule to take effect 2 years after it is published.