21 U.S.C. § 360eee–3 — National standards for third-party logistics providers

(a) Requirements No third-party logistics provider — a company that stores or ships drugs on behalf of others without owning the drugs — may operate in any state unless each of its facilities is licensed. If the state the drug is shipped from has its own licensure requirement, the facility must be licensed by that state, under regulations issued under subsection (d). If that state has no licensure requirement, the facility must instead be licensed by the Secretary, under the same regulations. If the drug is shipped across state lines, the facility must also be licensed by the state it's shipped into, if that state licenses third-party logistics providers and the facility isn't already licensed by the Secretary instead. (b) Reporting Starting 1 year after November 27, 2013, each facility must report to the Secretary once a year, on a schedule the Secretary sets: which state licensed it and the license's identification number, plus the facility's name, address, and every trade name it does business under. (c) Costs If a state has no licensing program, the Secretary licenses providers located there and may charge a reasonable fee to cover the cost of running the licensing program and doing periodic inspections — adjusted yearly to generate only the revenue actually needed. These fees can only be collected and spent to the extent Congress allows in advance through appropriations laws, though unspent fees don't expire, and money can be moved between Food and Drug Administration accounts as needed to cover them. If a state does run its own licensing program, nothing in this law stops it from charging its own fees for that license. If a state does not run one, it is still allowed to charge a state licensing fee on its own. (d) Regulations Within 2 years of November 27, 2013, the Secretary had to issue regulations setting licensing standards under subsection (a), including how licenses get revoked and reissued. Those regulations had to: - let a Secretary-approved outside accreditation program issue a license to any provider that meets this section's requirements, on request; - let the Secretary issue a license directly to a qualifying provider if no accreditation program meets the Secretary's own approval standards; - require providers to follow storage practices the Secretary sets, including keeping suitable warehouse space for safe operations (with a suitable area to quarantine suspect product), keeping adequate security, and having written policies for: receiving, securing, storing, and shipping product; identifying, recording, and reporting confirmed losses or thefts in the U.S.; correcting inventory errors; supporting manufacturer recalls; preparing for and handling foreseeable emergencies like a strike, fire, or flood; keeping expired product separate and returning or destroying it; tracing incoming and outgoing product and inventory; and quarantining or destroying suspect product when a manufacturer, wholesale distributor, dispenser, or government agency directs it to; - allow the licensing authority to periodically inspect the facility's warehouse space; - bar anyone convicted of a felony violation of the drug-adulteration or misbranding laws, or of the federal product-tampering law, from serving as a facility manager or designated representative; - require background checks for a facility's manager or designated representative; - require the provider to give licensing officials, on request, a list of every manufacturer, wholesale distributor, and dispenser it provides services for at that facility; and - make a license expire 3 years after it's issued, renewable for further 3-year terms. In writing these regulations, the Secretary had to skip the normal rulemaking shortcut in section 553 of title 5, and instead: issue a proposed rule including the regulation's text; take public comments for at least 60 days; and let the final regulation take effect only after a full year has passed since it was issued. (e) Validity A license issued under this section stays valid as long as the provider keeps meeting this section's requirements. If the Secretary finds that a third-party accreditation program has shown a provider meets every applicable licensing requirement, the Secretary must issue that provider a license.