Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part H— Pharmaceutical Distribution Supply Chain › § 360eee–4
Starting November 27, 2013, states and local governments must not make or keep rules about tracking drugs through the supply chain that conflict with or add to federal tracking rules. They also may not set different or weaker licensing rules for wholesale drug distributors (companies that buy and sell drugs in bulk) or third‑party logistics providers (companies that store or ship drugs for others). States may not treat those logistics companies as wholesale distributors, and state rules must also respect any federal waivers or limits. States may collect fees to help carry out the federal licensing program. They can still enforce state law in ways that fit the federal rules: they may fine businesses, suspend or revoke state licenses, impose penalties after convictions, and regulate licensed activities so long as those steps do not clash with the federal tracking and licensing rules. Rules that do not deal with tracking or these specific licenses are not affected.
Full Legal Text
Food and Drugs, Source: USLM XML via OLRC
Reference
Citation
21 U.S.C. § 360eee–4
Title 21, Food and Drugs
Last Updated
Apr 5, 2026
Release point: 119-73not60