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21 U.S.C. § 356e — Drug shortage list

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 356e — Drug shortage list

**(a) Establishment** The Secretary shall maintain an up-to-date list of drugs that are determined by the Secretary to be in shortage in the United States. **(b) Contents** For each drug on such list, the Secretary shall include the following information: (1) The name of the drug in shortage, including the National Drug Code number for such drug. (2) The name of each manufacturer of such drug. (3) The reason for the shortage, as determined by the Secretary, selecting from the following categories: (A) Requirements related to complying with good manufacturing practices. (B) Regulatory delay. (C) Shortage of an active ingredient. (D) Shortage of an inactive ingredient component. (E) Discontinuance of the manufacture of the drug. (F) Delay in shipping of the drug. (G) Demand increase for the drug. (4) The estimated duration of the shortage as determined by the Secretary. **(c) Public availability** (1) **In general** — Subject to paragraphs (2) and (3), the Secretary shall make the information in such list publicly available. (2) **Trade secrets and confidential information** — Nothing in this section alters or amends [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim) or [section 552(b)(4) of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552/b/4&num=0&edition=prelim). (3) **Public health exception** — The Secretary may choose not to make information collected under this section publicly available under paragraph (1) or [section 356c(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356c/c&num=0&edition=prelim) if the Secretary determines that disclosure of such information would advers

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Source location: Title 21, Chapter 9, § 356e; chapter-009-federal-food-drug-and-cosmetic-act.md

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Federal law — U.S. Code and appendices · legal_authorities

18 U.S.C. § 1905 — Disclosure of confidential information generally

Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.

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21 U.S.C. § 356c — Discontinuance or interruption in the production of life-saving drugs

**(a) In general** A manufacturer of a drug— (1) that is— (A) life-supporting; (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d&num=0&edition=prelim); 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, 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 discontinuati

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21 U.S.C. § 353b — Outsourcing facilities

**(a) In general** Sections 352(f)(1), 355, and 360eee–1 of this title shall not apply to a drug compounded by or under the direct supervision of a licensed pharmacist in a facility that elects to register as an outsourcing facility if each of the following conditions is met: (1) **Registration and reporting** — The drug is compounded in an outsourcing facility that is in compliance with the requirements of subsection (b). (2) **Bulk drug substances** — The drug is compounded in an outsourcing facility that does not compound using bulk drug substances (as defined in section 207.3(a)(4) of title 21, Code of Federal Regulations (or any successor regulation)), unless— (A) (i) the bulk drug substance appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need, by— (I) publishing a notice in the Federal Register proposing bulk drug substances to be included on the list, including the rationale for such proposal; (II) providing a period of not less than 60 calendar days for comment on the notice; and (III) publishing a notice in the Federal Register designating bulk drug substances for inclusion on the list; or (ii) the drug compounded from such bulk drug substance appears on the drug shortage list in effect under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim) at the time of compounding, distribution, and dispensing; (B) if an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph, the bulk drug substances each comply with the monograph; (C) the bulk drug substances a

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21 U.S.C. § 355 — New drugs

**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug. **(b) Filing application; contents** (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approv

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355–2 — Actions for delays of generic drugs and biosimilar biological products

**(a) Definitions** In this section— (1) the term “commercially reasonable, market-based terms” means— (A) a nondiscriminatory price for the sale of the covered product at or below, but not greater than, the most recent wholesale acquisition cost for the drug, as defined in [section 1395w–3a(c)(6)(B) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395w–3a/c/6/B&num=0&edition=prelim); (B) a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection (b)(2)(A)(iv); and (C) no additional conditions are imposed on the sale of the covered product; (2) the term “covered product”— (A) means— (i) any drug approved under subsection (c) or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or biological product licensed under subsection (a) or (k) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim); (ii) any combination of a drug or biological product described in clause (i); or (iii) when reasonably necessary to support approval of an application under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim), or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), as applicable, or otherwise meet the requirements for approval under either such section, any product, including any device, that is marketed or intended for use with such a drug or biological product; and (B) does not include any drug or biologica

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355–2

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 356d — Coordination; task force and strategic plan

**(a) Task force and strategic plan** (1) **In general** (A) *Task force* — As soon as practicable after July 9, 2012, the Secretary shall establish a task force to develop and implement a strategic plan for enhancing the Secretary’s response to preventing and mitigating drug shortages. (B) *Strategic plan* — The strategic plan described in subparagraph (A) shall include— (i) plans for enhanced interagency and intra-agency coordination, communication, and decisionmaking; (ii) plans for ensuring that drug shortages are considered when the Secretary initiates a regulatory action that could precipitate a drug shortage or exacerbate an existing drug shortage; (iii) plans for effective communication with outside stakeholders, including who the Secretary should alert about potential or actual drug shortages, how the communication should occur, and what types of information should be shared; (iv) plans for considering the impact of drug shortages on research and clinical trials; and (v) an examination of whether to establish a “qualified manufacturing partner program”, as described in subparagraph (C). (C) *Description of program* — In conducting the examination of a “qualified manufacturing partner program” under subparagraph (B)(v), the Secretary— (i) shall take into account that— (I) a “qualified manufacturer”, for purposes of such program, would need to have the capability and capacity to supply products determined or anticipated to be in shortage; and (II) in examining the capability and capacity to supply products in shortage, the “qualified manufacturer” could have a site that manufactures a drug listed under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 356d

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 356f — Hospital repackaging of drugs in shortage

**(a) Definitions** In this section: (1) **Drug** — The term “drug” excludes any controlled substance (as such term is defined in [section 802 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section802&num=0&edition=prelim)). (2) **Health system** — The term “health system” means a collection of hospitals that are owned and operated by the same entity and that share access to databases with drug order information for their patients. (3) **Repackage** — For the purposes of this section only, the term “repackage”, with respect to a drug, means to divide the volume of a drug into smaller amounts in order to— (A) extend the supply of a drug in response to the placement of the drug on a drug shortage list under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim); and (B) facilitate access to the drug by hospitals within the same health system. **(b) Exclusion from registration** Notwithstanding any other provision of this chapter, a hospital shall not be considered an establishment for which registration is required under [section 360 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360&num=0&edition=prelim) solely because it repackages a drug and transfers it to another hospital within the same health system in accordance with the conditions in subsection (c)— (1) during any period in which the drug is listed on the drug shortage list under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim); or (2) during the 60-day period following any period described in paragraph (1). **(c) Conditions** Subsection (b) shall only apply to a

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 356l — Advanced manufacturing technologies designation program

**(a) In general** Not later than 1 year after December 29, 2022, the Secretary shall initiate a program under which persons may request designation of an advanced manufacturing technology as described in subsection (b). **(b) Designation process** The Secretary shall establish a process for the designation under this section of methods of manufacturing drugs, including biological products, and active pharmaceutical ingredients of such drugs, as advanced manufacturing technologies. A method of manufacturing, or a combination of manufacturing methods, is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology, or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a drug while maintaining equivalent, or providing superior, drug quality, including by— (1) reducing development time for a drug using the designated manufacturing method; or (2) increasing or maintaining the supply of— (A) a drug that is life-supporting, life-sustaining, or of critical importance to providing health care; or (B) a drug that is on the drug shortage list under [section 356e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section356e&num=0&edition=prelim). **(c) Evaluation and designation of an advanced manufacturing technology** (1) **Submission** — A person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection (b) in a particular context of use. The Secretary may facilitate the development and review of

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21 U.S.C. § 374 — Inspection

**(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions** (1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in [section 350c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c&num=0&edition=prelim), when the standard for records inspection under paragraph (1) or (2) of [section 350c(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/a&num=0&edition=prelim) applies, subject to the limitations established in [section 350c(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/d&num=0&edition=prelim). In the case of a facility (as defined in [section 364 of this title](https://uscode.house.gov/vi

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21 U.S.C. § 381 — Imports and exports

**(a) Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission** The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or [section 387e(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/h&num=0&edition=prelim) and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of [section 360j(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 381

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