PRIA, Government Policy, Made Personal

Summary

The Secretary can order makers, importers, distributors, or pharmacists to stop sending out a controlled substance right away if there is a reasonable chance it could cause serious harm or death. Before issuing that order, the person who would be affected gets a chance to talk with the agency. After an order is issued, that person must get an informal hearing no later than 10 days after the order to challenge the evidence and discuss changes. After the hearing, the Secretary must either cancel the order, keep the stop-sale order in place until a date the Secretary sets, or change the order to require a recall with instructions on who must be told, a timetable for the recall, and a schedule for updates to the Secretary. If recalling would be more dangerous than leaving the product in use, the Secretary must not require a recall or a stop-sale. Anyone ordered must immediately stop distribution or carry out the recall and give the required notices. The Secretary can require notices to others and the public and can use help from health professionals who prescribed or dispensed the drug. Only the Secretary or a designee who is the Director of the Center for Drug Evaluation and Research or someone senior to that Director may issue these orders. This does not limit other recall powers or the ability to ask for voluntary actions under other laws.

Title 21, §360bbb–8d

Food and Drugs, Source: USLM XML via OLRC

(a)(1)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)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)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)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)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)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)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)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