§360eee–4 Uniform National Policy

Summary

Starting November 27, 2013, states may not make their own rules for tracing drugs through the supply chain if those rules conflict with, are stricter than, or add to the federal rules under section 353(e) or the related federal part and regulations. That includes rules about pedigrees, tracking or transaction records, verification, investigations, notifications, or recordkeeping for tracking drugs. States also may not ignore federal waivers, exceptions, or limits found under sections 360eee or 360eee–1. Also starting November 27, 2013, states may not set licensure rules for wholesale drug distributors or third‑party logistics providers (3PLs) that conflict with or duplicate the federal standards for distributors under section 353(e) or for 3PLs under section 360eee–3. States may not treat 3PLs as wholesale distributors. States may collect fees to run the federal licensing programs under sections 353(e), 360eee–2, and 360eee–3. States can still enforce their own laws by fines, license suspension or revocation, criminal or civil penalties for convictions, and other actions so long as those actions are consistent with the federal product‑tracing rules in section 360eee–1. Rules that do not relate to product tracing or the licensure topics above are not preempted.