Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c&num=0&edition=prelim
Timestamp: 2020-08-04 12:09:41
Document Index: 540160256

Matched Legal Cases: ['§506', '§131', '§1001', '§3101', '§3111', '§3112', '§3112', '§3111', '§3111', '§3111', '§3112', '§3112', '§3112']

21 USC 356c: Discontinuance or interruption in the production of life-saving drugs Text contains those laws in effect on August 3, 2020
(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
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 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.
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.
(j) 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.)
2020-Subsec. (a). Pub. L. 116–136, §3112(a)(2), in concluding provisions, inserted ", 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," before "and the reasons" and inserted at end "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."
Subsec. (a)(1)(C). Pub. L. 116–136, §3112(a)(1), inserted "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" after "during surgery".
Subsec. (g). Pub. L. 116–136, §3111(1), which directed substitution of "the Secretary shall, as appropriate" for "the Secretary may" in par. (1), was executed by making the substitution in introductory provisions to reflect the probable intent of Congress.
Subsec. (g)(1). Pub. L. 116–136, §3111(2), inserted "prioritize and" before "expedite the review".
Subsec. (g)(2). Pub. L. 116–136, §3111(3), inserted "prioritize and" before "expedite an inspection".
Subsec. (j). Pub. L. 116–136, §3112(b), added subsec. (j).
Pub. L. 116–136, div. A, title III, §3112(g), Mar. 27, 2020, 134 Stat. 363 , provided that: "The amendments made by this section [amending this section and sections 356e, 360, and 374 of this title] and section 3111 [amending this section] shall take effect on the date that is 180 days after the date of enactment of this Act [Mar. 27, 2020]."
Construction of 2020 Amendment: Confidentiality
Pub. L. 116–136, div. A, title III, §3112(f), Mar. 27, 2020, 134 Stat. 363 , provided that: "Nothing in the amendments made by this section [see Effective Date of 2020 Amendment note set out above] 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, United States Code, or section 1905 of title 18, United States Code."