PRIA, Government Policy, Made Personal

Summary

The Secretary can order makers, importers, distributors, or pharmacists to stop selling or to recall a controlled substance if there is a reasonable chance it could cause serious harm or death. Before issuing the order, the person affected gets a chance to talk with the agency. The person also gets a short informal hearing no later than 10 days after the order to decide if the order should be changed. After that, the Secretary will either cancel the order, keep the stop-sale order until a set date, or change it to require a recall with rules about who must be warned, a timeline, and regular updates to the Secretary. If recalling the drug would be more dangerous than leaving it in use, the Secretary will not order a recall or a stop-sale. Anyone ordered to stop distribution or to recall must do so right away and must give any required notices. The Secretary can require notices to manufacturers, sellers, and the public and may use health professionals to help. Only the Secretary or a very senior official (the Director of the Center for Drug Evaluation and Research or someone above them) can sign these orders. This authority does not limit other powers the Secretary has under related laws or the ability to ask for voluntary actions.

Title 21, §360bbb–8d

Food and Drugs, Source: USLM XML via OLRC

(a)Order to cease distribution and recall

(1)In general

If the Secretary determines there is a reasonable probability that a controlled substance would cause serious adverse health consequences or death, the Secretary may, after providing the appropriate person with an opportunity to consult with the agency, issue an order requiring manufacturers, importers, distributors, or pharmacists, who distribute such controlled substance to immediately cease distribution of such controlled substance.

(2)Hearing

An order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify an amendment to the order, and what actions are required by such amended order pursuant to subparagraph (3).

(3)Order resolution

After an order is issued according to the process under paragraphs (1) and (2), the Secretary shall, except as provided in paragraph (4)—

(A)vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;

(B)continue the order ceasing distribution of the controlled substance until a date specified in such order; or

(C)amend the order to require a recall of the controlled substance, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.

(4)Risk assessment

If the Secretary determines that the risk of recalling a controlled substance presents a greater health risk than the health risk of not recalling such controlled substance from use, an amended order under subparagraph (B) or (C) of paragraph (3) shall not include either a recall order for, or an order to cease distribution of, such controlled substance, as applicable.

(5)Action following order

Any person who is subject to an order pursuant to subparagraph (B) or (C) of paragraph (3) shall immediately cease distribution of or recall, as applicable, the controlled substance and provide notification as required by such order.

(b)Notice to persons affected

If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) to provide either a notice of a recall order for, or an order to cease distribution of, such controlled substance, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. In providing such notice, the Secretary may use the assistance of health professionals who prescribed or dispensed such controlled substances.

(c)Nondelegation

An order described in subsection (a)(3) shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the Center for Drug Evaluation and Research or an official senior to such Director.

(d)Savings clause

Nothing contained in this section shall be construed as limiting—

(1)the authority of the Secretary to issue an order to cease distribution of, or to recall, any drug under any other provision of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.]; or

(2)the ability of the Secretary to request any person to perform a voluntary activity related to any drug subject to this chapter or the Public Health Service Act.

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (d), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see

Short Title

note set out under section 201 of Title 42 and Tables.

§360bbb–8d Notification, Nondistribution, and Recall of Controlled Substances