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21 U.S.C. § 360bbb–3a — Emergency use of medical products

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

21 U.S.C. § 360bbb–3a — Emergency use of medical products

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Source file: Laws/federal/codes/united-states-code/title-21/section-360bbb3a-emergency-use-of-medical-products--45effdbde7.md
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Source location: Title 21, Chapter 9, § 360bbb–3a; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) Definitions** In this section: (1) **Eligible product** — The term “eligible product” means a product that— (A) is approved or cleared under this subchapter, conditionally approved under [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim), or licensed under section 351 of the Public Health Service Act [[42 U.S.C. 262](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim)]; (B) (i) is intended for use to prevent, diagnose, or treat a disease or condition involving a biological, chemical, radiological, or nuclear agent or agents; or (ii) is intended for use to prevent, diagnose, or treat a serious or life-threatening disease or condition caused by a product described in clause (i); and (C) is intended for use during the circumstances under which— (i) a determination described in subparagraph (A), (B), or (C) of [section 360bbb–3(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb–3/b/1&num=0&edition=prelim) has been made by the Secretary of Homeland Security, the Secretary of Defense, or the Secretary, respectively; or (ii) the identification of a material threat described in subparagraph (D) of [section 360bbb–3(b)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb–3/b/1&num=0&edition=prelim) has been made pursuant to section 319F–2 of the Public Health Service Act [[42 U.S.C. 247d–6b](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d–6b&num=0&edition=prelim)]. (2) **Product** — The term “product” means a drug, device, or biological product. **(b) Expiration dating** (1) **In general** — The Secretary may extend the expiration date and authorize the introduction or delivery for introduction into interstate commerce of an eligible product after the expiration date provided by the manufacturer if— (A) the expiration date extension is intended to support the United States ability to protect— (i) the public health; or (ii) military preparedness and effectiveness; and (B) the expiration date extension is supported by an appropriate scientific evaluation that is conducted or accepted by the Secretary. (2) **Requirements and conditions** — Any extension of an expiration date under paragraph (1) shall, as part of the extension, identify— (A) each specific lot, batch, or other unit of the product for which extended expiration is authorized; (B) the duration of the extension; and (C) any other requirements or conditions as the Secretary may deem appropriate for the protection of the public health, which may include requirements for, or conditions on, product sampling, storage, packaging or repackaging, transport, labeling, notice to product recipients, recordkeeping, periodic testing or retesting, or product disposition. (3) **Effect** — Notwithstanding any other provision of this chapter or the Public Health Service Act [[42 U.S.C. 201](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim) et seq.], an eligible product shall not be considered an unapproved product (as defined in [section 360bbb–3(a)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb–3/a/2/A&num=0&edition=prelim)) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such product, the Secretary has, under paragraph (1), extended the expiration date and authorized the introduction or delivery for introduction into interstate commerce of such product after the expiration date provided by the manufacturer. (4) **Expiration date** — For purposes of this subsection, the term “expiration date” means the date established through appropriate stability testing required by the regulations issued by the Secretary to ensure that the product meets applicable standards of identity, strength, quality, and purity at the time of use. **(c) Current good manufacturing practice** (1) **In general** — The Secretary may, when the circumstances of a domestic, military, or public health emergency or material threat described in subsection (a)(1)(C) so warrant, authorize, with respect to an eligible product, deviations from current good manufacturing practice requirements otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this chapter, including requirements under section 351 or 360j(f)(1) of this title or applicable conditions prescribed with respect to the eligible product by an order under [section 360j(f)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/f/2&num=0&edition=prelim). (2) **Effect** — Notwithstanding any other provision of this chapter or the Public Health Service Act [[42 U.S.C. 201](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim) et seq.], an eligible product shall not be considered an unapproved product (as defined in [section 360bbb–3(a)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb–3/a/2/A&num=0&edition=prelim)) and shall not be deemed adulterated or misbranded under this chapter because, with respect to such product, the Secretary has authorized deviations from current good manufacturing practices under paragraph (1). **(d) Emergency dispensing** The requirements of subsections (b) and (f) of section 353, section 354, and [section 360j(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/e&num=0&edition=prelim) shall not apply to an eligible product, and the product shall not be considered an unapproved product (as defined in [section 360bbb–3(a)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb–3/a/2/A&num=0&edition=prelim)) and shall not be deemed adulterated or misbranded under this chapter because it is dispensed without an individual prescription, if— (1) the product is dispensed during the circumstances described in subsection (a)(1)(C); and (2) such dispensing without an individual prescription occurs— (A) as permitted under the law of the State in which the product is dispensed; or (B) in accordance with an order issued by the Secretary, for the purposes and duration of the circumstances described in subsection (a)(1)(C). **(e) Emergency use instructions** (1) **In general** — The Secretary, acting through an appropriate official within the Department of Health and Human Services, may create and issue emergency use instructions to inform health care providers or individuals to whom an eligible product is to be administered concerning such product’s approved, licensed, or cleared conditions of use. (2) **Effect** — Notwithstanding any other provisions of this chapter or the Public Health Service Act [[42 U.S.C. 201](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim) et seq.], a product shall not be considered an unapproved product and shall not be deemed adulterated or misbranded under this chapter because of the issuance of emergency use instructions under paragraph (1) with respect to such product or the introduction or delivery for introduction of such product into interstate commerce accompanied by such instructions— (A) during an emergency response to an actual emergency that is the basis for a determination described in subsection (a)(1)(C); or (B) by a government entity (including a Federal, State, local, or tribal government entity), or a person acting on behalf of such a government entity, in preparation for an emergency response.

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

21 U.S.C. § 360ccc — Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs

**(a) Application requirements** (1) (A) Except as provided in paragraph (3), any person may file with the Secretary an application for conditional approval of— (i) a new animal drug intended for a minor use or a minor species; or (ii) a new animal drug not intended for a minor use or minor species— (I) that is intended to treat a serious or life-threatening disease or condition or addresses an unmet animal or human health need; and (II) for which the Secretary determines that a demonstration of effectiveness would require a complex or particularly difficult study or studies. (B) The Secretary shall, not later than September 30, 2019, issue guidance or regulations further clarifying the criteria specified in subparagraph (A)(ii). (C) An application under this paragraph shall comply in all respects with the provisions of [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim) except for subsections (a)(4), (b)(2), (c)(1), (c)(2), (c)(3), (d)(1), (e), (h), and (n) of such section unless otherwise stated in this section, and any additional provisions of this section. (D) New animal drugs for which conditional approval is sought under this section are subject to the same safety standards that would be applied to new animal drugs under [section 360b(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b/d&num=0&edition=prelim) (including, for antimicrobial new animal drugs, with respect to antimicrobial resistance). (2) The applicant shall submit to the Secretary as part of an application for the conditional approval of a new animal drug— (A) all information necessary to meet the requirements of [section 360b(b)(1) o

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360ccc

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

42 U.S.C. § 201 — Funding

Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.

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

42 U.S.C. § 262 — Regulation of biological products

**(a) Biologics license** (1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless— (A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and (B) each package of the biological product is plainly marked with— (i) the proper name of the biological product contained in the package; (ii) the name, address, and applicable license number of the manufacturer of the biological product; and (iii) the expiration date of the biological product. (2) (A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses. (B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)]. (C) The Secretary shall approve a biologics license application— (i) on the basis of a demonstration that— (I) the biological product that is the subject of the application is safe, pure, and potent; and (II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and (ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). (D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub

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

42 U.S.C. § 247d–6b — Strategic National Stockpile and security countermeasure procurements

**(a) Strategic National Stockpile** (1) **In general** — The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, and in coordination with the Secretary of Homeland Security (referred to in this section as the “Homeland Security Secretary”), shall maintain a stockpile or stockpiles of drugs, vaccines and other biological products, medical devices, and other supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests in the stockpile) in such numbers, types, and amounts as are determined consistent with [section 300hh–10 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300hh-10&num=0&edition=prelim) by the Secretary to be appropriate and practicable, taking into account other available sources, to provide for and optimize the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency and, as informed by existing recommendations of, or consultations with, the Public Health Emergency Medical Countermeasure Enterprise established under [section 300hh–10a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section300hh-10a&num=0&edition=prelim), make necessary additions or modifications to the contents of such stockpile or stockpiles based on the review conducted under paragraph (2). (2) **Threat-based review** (A) *In general* — The Secretary shall conduct an annual threat-based review

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247d–6b

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

42 U.S.C. § 201 — Definitions

Page 35 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 201 1 See References in Text note below. Sec. 300jj–34. Competitive grants to States and Indian tribes for the development of loan pro- grams to facilitate the widespread adoption of certified EHR technology. 300jj–35. Demonstration program to integrate in- formation technology into clinical education. 300jj–36. Information technology professionals in health care. 300jj–37. General grant and loan provisions. 300jj–38. Authorization for appropriations. PART C—OTHER PROVISIONS 300jj–51. Health information technology enroll- ment standards and protocols. 300jj–52. Information blocking. SUBCHAPTER XXIX—DATA COLLECTION, ANALYSIS, AND QUALITY 300kk. Data collection, analysis, and quality. SUBCHAPTER XXX—COMMUNITY LIVING ASSISTANCE SERVICES AND SUPPORTS 300ll to 300ll–9. Repealed. SUBCHAPTER XXXI—WORLD TRADE CENTER HEALTH PROGRAM PART A—ESTABLISHMENT OF PROGRAM; ADVISORY COMMITTEE 300mm. Establishment of World Trade Center Health Program. 300mm–1. WTC Health Program Scientific/Tech- nical Advisory Committee; WTC Health Program Steering Committees. 300mm–2. Education and outreach. 300mm–3. Uniform data collection and analysis. 300mm–4. Clinical Centers of Excellence and Data Centers. 300mm–5. Definitions. PART B—PROGRAM OF MONITORING, INITIAL HEALTH EVALUATIONS, AND TREATMENT SUBPART 1—WTC RESPONDERS 300mm–21. Identification of WTC responders and provision of WTC-related monitoring services. 300mm–22. Treatment of enrolled WTC responders for WTC-related health conditions. 300mm–23. National arrangement for benefits for el- igible individuals outside New York. SUBPART 2—WTC SURVIVORS 300mm–31. Identification and initial health evalua- tion of screening-eligible and

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

42 U.S.C. § 247d — Public health emergencies

**(a) Emergencies** If the Secretary determines, after consultation with such public health officials as may be necessary, that— (1) a disease or disorder presents a public health emergency; or (2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs (1) and (2). Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination. **(b) Public Health Emergency Fund** (1) **In general** — There is established in the Treasury a fund to be designated as the “Public Health Emergency Fund” to be made available to the Secretary without fiscal year limitation to carry out subsection (a) only if a public health emergency has been declared by the Secretary under such subsection or if the Secretary determines there is the significant potential for a public health emergency, to allow the Se

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

42 U.S.C. § 247d — Public health emergencies

Page 228 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 247c–2 which the delivery of services under sub- section (a) may be improved. The Secretary may make such grants only to grantees under such subsection and to public and nonprofit private entities that are carrying out pro- grams substantially similar to programs car- ried out under such subsection. (2) Authorization of appropriations For the purpose of carrying out paragraph (1), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1993 through 1998. (July 1, 1944, ch. 373, title III, § 318A, as added Pub. L. 102–531, title III, § 304, Oct. 27, 1992, 106 Stat. 3490; amended Pub. L. 103–43, title XX, § 2008(i)(1)(B)(ii), June 10, 1993, 107 Stat. 212; Pub. L. 103–183, title IV, § 402, Dec. 14, 1993, 107 Stat. 2236; Pub. L. 107–251, title VI, § 601(a), Oct. 26, 2002, 116 Stat. 1664; Pub. L. 108–163, § 2(m)(1), Dec. 6, 2003, 117 Stat. 2023.) Editorial Notes REFERENCES IN TEXT The reference to section 254b of this title the first place appearing, referred to in subsec. (e), was in the original a reference to section 329, meaning section 329 of act July 1, 1944, which was omitted in the general amendment of subpart I (§ 254b et seq.) of part D of this subchapter by Pub. L. 104–299, § 2, Oct. 11, 1996, 110 Stat. 3626. Section 256a of this title, referred to in subsec. (e), was repealed by Pub. L. 104–299, § 4(a)(3), Oct. 11, 1996, 110 Stat. 3645. AMENDMENTS 2003—Subsec. (e). Pub. L. 108–163 substituted ‘‘254b’’ for ‘‘254c, 254b(h)’’ before ‘‘, 256a’’. 2002—Subsec. (e). Pub. L. 107–251 substituted ‘‘254b(h)’’ for ‘‘256’’. 1993—Pub. L. 103–43 made technical amendment to di- rectory language of Pub. L. 102–531, § 304, which enacted this section. Subs

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 247d

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

42 U.S.C. § 262 — Regulation of biological products

Page 456 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 258a § 258a. Transferred Editorial Notes CODIFICATION Section, act July 8, 1947, ch. 210, title II, § 201, 61 Stat. 269, which related to transfer of balances in working capital fund, narcotic hospitals, to surplus fund, was transferred and is set out as a note under section 290aa of this title. §§ 259 to 261a. Repealed. Pub. L. 106–310, div. B, title XXXIV, § 3405(a), Oct. 17, 2000, 114 Stat. 1221, as amended by Pub. L. 114–198, title I, § 110(b), July 22, 2016, 130 Stat. 710 Section 259, acts July 1, 1944, ch. 373, title III, § 343, 58 Stat. 699; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240; Pub. L. 92–293, § 3, May 11, 1972, 86 Stat. 136; Pub. L. 98–473, title II, § 232(b), Oct. 12, 1984, 98 Stat. 2031, related to convict addicts or other persons with drug abuse or drug dependence problems. Section 260, acts July 1, 1944, ch. 373, title III, § 344, 58 Stat. 701; June 25, 1948, ch. 654, § 5, 62 Stat. 1018; July 24, 1956, ch. 676, title III, § 302(b), 70 Stat. 622; Pub. L. 91–513, title I, § 2(a)(2)(A), (3), (4), Oct. 27, 1970, 84 Stat. 1240, re- lated to addicts and persons with drug abuse or drug dependence problems. Section 260a, act July 1, 1944, ch. 373, title III, § 345, as added May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended July 24, 1956, ch. 676, title III, § 302(c), 70 Stat. 622; Pub. L. 91–358, title I, § 155(c)(32), July 29, 1970, 84 Stat. 572, re- lated to admission of addicts committed from District of Columbia. Section 261, acts July 1, 1944, ch. 373, title III, § 346, formerly § 345, 58 Stat. 701; renumbered § 346, May 8, 1954, ch. 195, § 2, 68 Stat. 79; amended Pub. L. 91–513, title I, § 2(a)(2)(A), (5), Oct. 27, 1970, 84 Stat. 1240, relate

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