Discontinuance or interruption in the production of life-saving drugs
A manufacturer of a drug—
(B) life-sustaining; or
(C) intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 247d of title 42; and
(2) that is not a radio pharmaceutical drug product or any other product as designated by the Secretary,
shall notify the Secretary, in accordance with subsection (b), of a permanent discontinuance in the manufacture of the drug or an interruption of the manufacture of the drug that is likely to lead to a meaningful disruption in the supply of that drug in the United States,,1
1 So in original.
or a permanent discontinuance in the manufacture of an active pharmaceutical ingredient or an interruption in the manufacture of the active pharmaceutical ingredient of such drug that is likely to lead to a meaningful disruption in the supply of the active pharmaceutical ingredient of such drug, and the reasons for such discontinuance or interruption. Notification under this subsection shall include disclosure of reasons for the discontinuation or interruption, and if applicable, an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation or interruption, the source of the active pharmaceutical ingredient and any alternative sources for the active pharmaceutical ingredient known by the manufacturer; whether any associated device used for preparation or administration included in the drug is a reason for, or a risk factor in, such discontinuation or interruption; the expected duration of the interruption; and such other information as the Secretary may require.
A notice required under subsection (a) shall be submitted to the Secretary—
(1) at least 6 months prior to the date of the discontinuance or interruption; or
(2) if compliance with paragraph (1) is not possible, as soon as practicable.
To the maximum extent practicable, the Secretary shall distribute, through such means as the Secretary deems appropriate, information on the discontinuance or interruption of the manufacture of the drugs described in subsection (a) to appropriate organizations, including physician, health provider, and patient organizations, as described in section 356e of this title.
Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.
Coordination with Attorney General
Not later than 30 days after the receipt of a notification described in subsection (a), the Secretary shall—
(1) determine whether the notification pertains to a controlled substance subject to a production quota under section 826 of this title; and
if necessary, as determined by the Secretary—
(A) notify the Attorney General that the Secretary has received such a notification;
(B) request that the Attorney General increase the aggregate and individual production quotas under section 826 of this title applicable to such controlled substance and any ingredient therein to a level the Secretary deems necessary to address a shortage of a controlled substance based on the best available market data; and
(C) if the Attorney General determines that the level requested is not necessary to address a shortage of a controlled substance, the Attorney General shall provide to the Secretary a written response detailing the basis for the Attorney General’s determination.
The Secretary shall make the written response provided under subparagraph (C) available to the public on the Internet Web site of the Food and Drug Administration.
Failure to meet requirements
If a person fails to submit information required under subsection (a) in accordance with subsection (b)—
(1) the Secretary shall issue a letter to such person informing such person of such failure;
(2) not later than 30 calendar days after the issuance of a letter under paragraph (1), the person who receives such letter shall submit to the Secretary a written response to such letter setting forth the basis for noncompliance and providing information required under subsection (a); and
(3) not later than 45 calendar days after the issuance of a letter under paragraph (1), the Secretary shall make such letter and any response to such letter under paragraph (2) available to the public on the Internet Web site of the Food and Drug Administration, with appropriate redactions made to protect information described in subsection (d), except that, if the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not notifying as required under subsection (a), the requirements of this paragraph shall not apply.
Expedited inspections and reviews
If, based on notifications described in subsection (a) or any other relevant information, the Secretary concludes that there is, or is likely to be, a drug shortage of a drug described in subsection (a), the Secretary shall, as appropriate—
(1) prioritize and expedite the review of a supplement to a new drug application submitted under section 355(b) of this title, an abbreviated new drug application submitted under section 355(j) of this title, or a supplement to such an application submitted under section 355(j) of this title, that could help mitigate or prevent such shortage; or
(2) prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent such drug shortage.
For purposes of this section—
the term “drug”—
(A) means a drug (as defined in section 321(g) of this title) that is intended for human use and that is subject to section 353(b)(1) of this title; and
(B) does not include biological products (as defined in section 262 of title 42), unless otherwise provided by the Secretary in the regulations promulgated under subsection (i);
(2) the term “drug shortage” or “shortage”, with respect to a drug, means a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug; and
the term “meaningful disruption”—
(A) means a change in production that is reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product; and
(B) does not include interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.
Not later than 18 months after July 9, 2012, the Secretary shall adopt a final regulation implementing this section.
Such regulation shall define, for purposes of this section, the terms “life-supporting”, “life-sustaining”, and “intended for use in the prevention or treatment of a debilitating disease or condition”.
Inclusion of biological products
The Secretary may by regulation apply this section to biological products (as defined in section 262 of title 42), including plasma products derived from human plasma protein and their recombinant analogs, if the Secretary determines such inclusion would benefit the public health. Such regulation shall take into account any supply reporting programs and shall aim to reduce duplicative notification.
Rule for vaccines
If the Secretary applies this section to vaccines pursuant to subparagraph (A), the Secretary shall—
(i) consider whether the notification requirement under subsection (a) may be satisfied by submitting a notification to the Centers for Disease Control and Prevention under the vaccine shortage notification program of such Centers; and
(ii) explain the determination made by the Secretary under clause (i) in the regulation.
In promulgating a regulation implementing this section, the Secretary shall—
(A) issue a notice of proposed rulemaking that includes the proposed regulation;
(B) provide a period of not less than 60 days for comments on the proposed regulation; and
(C) publish the final regulation not less than 30 days before the regulation’s effective date.
Notwithstanding any other provision of Federal law, in implementing this section, the Secretary shall only promulgate regulations as described in paragraph (4).
Risk management plans
Each manufacturer of a drug described in subsection (a) or of any active pharmaceutical ingredient or any associated medical device used for preparation or administration included in the drug, shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the drug, as applicable, for each establishment in which such drug or active pharmaceutical ingredient of such drug is manufactured. A risk management plan under this section shall be subject to inspection and copying by the Secretary pursuant to an inspection or a request under section 374(a)(4) of this title.
(June 25, 1938, ch. 675, § 506C, as added Pub. L. 105–115, title I, § 131(a), Nov. 21, 1997, 111 Stat. 2332; amended Pub. L. 112–144, title X, § 1001(a), July 9, 2012, 126 Stat. 1099; Pub. L. 114–255, div. A, title III, § 3101(a)(2)(E), Dec. 13, 2016, 130 Stat. 1153; Pub. L. 116–136, div. A, title III, §§ 3111–3112(b), Mar. 27, 2020, 134 Stat. 361, 362.)