§360eee–4 Uniform national policy

Summary

Starting November 27, 2013, states may not make or keep rules about tracing products through the drug supply chain that conflict with, are tougher than, or add to the federal tracing rules. That covers things like distribution histories, transaction records, verification, investigation, disposal, notifications, recordkeeping, paper or electronic pedigrees, and tracking or tracing drugs. States also must not conflict with any federal waivers, exceptions, or limits under the related federal rules. Also starting that date, states may not set licensure rules for wholesale drug distributors or third‑party logistics providers that clash with or duplicate the federal standards. States may not treat third‑party logistics providers as wholesale distributors. States may collect fees to run the federal licensing program. States can enforce state laws that follow federal rules, suspend or revoke state licenses, impose fines or other penalties after convictions for drug-law violations, and regulate licensed businesses in ways that match the federal tracing rules. Rules not about tracing or these licenses are not affected.