21 U.S.C. § 360bbb–8d — Notification, nondistribution, and recall of controlled substances

(a) Order to cease distribution and recall (1) In general. If the Secretary decides there is a "reasonable probability" that a controlled substance would cause serious health harm or death, the Secretary may order manufacturers, importers, distributors, or pharmacists who distribute it to immediately stop — but only after giving them a chance to consult with the agency first. (2) Hearing. That order must offer the affected person an informal hearing, held within 10 days of the order, on whether there is enough evidence to justify amending the order, and what an amended order should require. (3) Order resolution. After that process, the Secretary must, unless (4) applies, do one of three things: (A) cancel the order if there are not adequate grounds to support it; (B) keep the stop-distribution order in place until a set date; or (C) amend the order to require a recall — including who must be notified, a recall timetable, and a schedule for updates to the Secretary. (4) Risk assessment. If the Secretary decides that recalling the substance would pose a greater health risk than not recalling it, the amended order cannot include a recall requirement or a stop-distribution requirement. (5) Action following order. Anyone subject to a (B) or (C) order under paragraph (3) must immediately stop distributing or recall the substance, as required, and give the notice the order demands. (b) Notice to persons affected. If the Secretary decides it is necessary, the Secretary may require the person under the order to notify others — manufacturers, distributors, importers, sellers, and the public — about the recall or stop-distribution order. The Secretary may use the help of health professionals who prescribed or dispensed the substance to give that notice. (c) Nondelegation. Only the Secretary, or an official the Secretary designates, may issue an order described in subsection (a)(3). That designated official must be the Director of the Center for Drug Evaluation and Research, or someone senior to that Director — no one else can be given this power. (d) Savings clause. Nothing in this section limits (1) the Secretary's authority to order a drug's recall or stop distribution under any other provision of this chapter or the Public Health Service Act (42 U.S.C. § 201 et seq.), or (2) the Secretary's ability to ask anyone to voluntarily act on a drug covered by those laws.