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42 U.S.C. § 290ee — Opioid overdose reversal medication access, education, and co-prescribing grant programs

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

42 U.S.C. § 290ee — Opioid overdose reversal medication access, education, and co-prescribing grant programs

**(a) Grants** The Secretary shall make grants to States, localities, Indian Tribes, and Tribal organizations (as those terms are defined in [section 5304 of title 25](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5304&num=0&edition=prelim)) to— (1) implement strategies that increase access to drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.] for emergency treatment of known or suspected opioid overdose, as appropriate, pursuant to a standing order; (2) encourage pharmacies to dispense opioid overdose reversal medication pursuant to a standing order; (3) encourage health care providers to co-prescribe, as appropriate, drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; (4) develop or provide training materials that persons authorized to prescribe or dispense a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose may use to educate the public concerning— (A) when and how to safely administer such drug or device; and (B) steps to be taken after administering such drug or device; and (5) educate the public concerning the availability of drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose without a person-specific prescription. **(b) Certain requirement** A grant may be made under this

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Source location: Title 42, Chapter 6A, § 290ee; chapter-6a-public-health-service.md

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**(a) Grants** The Secretary shall make grants to States, localities, Indian Tribes, and Tribal organizations (as those terms are defined in [section 5304 of title 25](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5304&num=0&edition=prelim)) to— (1) implement strategies that increase access to drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.] for emergency treatment of known or suspected opioid overdose, as appropriate, pursuant to a standing order; (2) encourage pharmacies to dispense opioid overdose reversal medication pursuant to a standing order; (3) encourage health care providers to co-prescribe, as appropriate, drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; (4) develop or provide training materials that persons authorized to prescribe or dispense a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose may use to educate the public concerning— (A) when and how to safely administer such drug or device; and (B) steps to be taken after administering such drug or device; and (5) educate the public concerning the availability of drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose without a person-specific prescription. **(b) Certain requirement** A grant may be made under this section only if the State involved has authorized standing orders to be issued for drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose. **(c) Preference in making grants** In making grants under this section, the Secretary may give preference to States that have a significantly higher rate of opioid overdoses than the national average, and that— (1) have not implemented standing orders regarding drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; (2) authorize standing orders to be issued that permit community-based organizations, substance abuse programs, or other nonprofit entities to acquire, dispense, or administer drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; or (3) authorize standing orders to be issued that permit police, fire, or emergency medical services agencies to acquire and administer drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose. **(d) Grant terms** (1) **Number** — A State may not receive more than one grant under this section at a time. (2) **Period** — A grant under this section shall be for a period of 5 years. (3) **Limitations** — A State may— (A) use not more than 10 percent of a grant under this section for educating the public pursuant to subsection (a)(5); and (B) use not less than 20 percent of a grant under this section to offset cost-sharing for distribution and dispensing of drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose. **(e) Applications** To be eligible to receive a grant under this section, a State shall submit an application to the Secretary in such form and manner and containing such information as the Secretary may reasonably require, including detailed proposed expenditures of grant funds. **(f) Reporting** A State that receives a grant under this section shall, at least annually for the duration of the grant, submit a report to the Secretary evaluating the progress of the activities supported through the grant. Such reports shall include information on the number of pharmacies in the State that dispense a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose under a standing order, and other information as the Secretary determines appropriate to evaluate the use of grant funds. **(g) Definitions** In this section the term “standing order” means a document prepared by a person authorized to prescribe medication that permits another person to acquire, dispense, or administer medication without a person-specific prescription. **(h) Authorization of appropriations** (1) **In general** — To carry out this section, there are authorized to be appropriated $5,000,000 for the period of fiscal years 2023 through 2027. (2) **Administrative costs** — Not more than 3 percent of the amounts made available to carry out this section may be used by the Secretary for administrative expenses of carrying out this section.

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

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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

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

25 U.S.C. § 5304 — Authorization of appropriations

**(a) In general** There are authorized to be appropriated such sums as may be necessary to carry out this subchapter. **(b) Availability of appropriations** Notwithstanding any other provision of this chapter, the provision of funds under this chapter shall be subject to the availability of appropriations and the Secretary is not required to reduce funding for programs, projects, or activities serving a tribe in order to make funds available to another tribe or tribal organization under this chapter.

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

21 U.S.C. § 1181 — Contract authority

The authority of the Secretary to enter into contracts under this subchapter and subchapter V shall be effective for any fiscal year only to such extent or in such amounts as are provided in advance by appropriation Acts.

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

21 U.S.C. § 1191 to 1193 — Transferred

### Statutory Notes #### Codification Section 1191, Pub. L. 92–255, title V, § 501, Mar. 21, 1972, 86 Stat. 85; Pub. L. 93–282, title II, § 204, May 14, 1974, 88 Stat. 136; Pub. L. 94–237, § 12(a), Mar. 19, 1976, 90 Stat. 247; Pub. L. 96–181, § 10, Jan. 2, 1980, 93 Stat. 1314; Pub. L. 97–35, title IX, § 973(f), Aug. 13, 1981, 95 Stat. 598, which established the National Institute on Drug Abuse, was redesignated section 503(a)–(d) of the Public Health Service Act by Pub. L. 98–24, § 2(b)(4), Apr. 26, 1983, 97 Stat. 177, transferred to section 290aa–2(a)–(d) of Title 42, The Public Health and Welfare, and subsequently repealed. Section 1192, Pub. L. 92–255, title V, § 502, as added Pub. L. 94–237, § 12(b)(1), Mar. 19, 1976, 90 Stat. 247; amended Pub. L. 95–461, § 5, Oct. 14, 1978, 92 Stat. 1269; Pub. L. 96–181, § 11, Jan. 2, 1980, 93 Stat. 1315, which related to the coordination, information, assistance, and assignment activities and services, was redesignated section 524 of the Public Health Service Act by Pub. L. 98–24, § 2(b)(15), Apr. 26, 1983, 97 Stat. 181, transferred to [section 290ee of Title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section290ee&num=0&edition=prelim), and subsequently omitted. Section 1193, Pub. L. 92–255, title V, § 503, as added Pub. L. 94–237, § 13(a), Mar. 19, 1976, 90 Stat. 248; amended Pub. L. 95–461, § 2(c), Oct. 14, 1978, 92 Stat. 1268; Pub. L. 96–181, § 12, Jan. 2, 1980, 93 Stat. 1315; Pub. L. 97–35, title IX, § 972(a), (b), Aug. 13, 1981, 95 Stat. 597, which related to research and development functions, was redesignated section 515 of the Public Health Service Act by Pub. L. 98–24, § 2(b)(11), Apr. 26, 1983, 97 Stat. 180, transferred to [section 290cc of Title 42](https://uscode.house.gov/view.xhtml?re

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

42 U.S.C. § 290cc–24 — Determination of amount of allotment

**(a) Minimum allotment** The allotment for a State under [section 290cc–21 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section290cc-21&num=0&edition=prelim) for a fiscal year shall be the greater of— (1) $300,000 for each of the several States, the District of Columbia, and the Commonwealth of Puerto Rico, and $50,000 for each of Guam, the Virgin Islands, American Samoa, and the Commonwealth of the Northern Mariana Islands; and (2) an amount determined in accordance with subsection (b). **(b) Determination under formula** The amount referred to in subsection (a)(2) is the product of— (1) an amount equal to the amount appropriated under [section 290cc–35(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section290cc–35/a&num=0&edition=prelim) for the fiscal year; and (2) a percentage equal to the quotient of— (A) an amount equal to the population living in urbanized areas of the State involved, as indicated by the most recent data collected by the Bureau of the Census; and (B) an amount equal to the population living in urbanized areas of the United States, as indicated by the sum of the respective amounts determined for the States under subparagraph (A).

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

21 U.S.C. § 301 — Short title

Page 30 TITLE 21—FOOD AND DRUGS § 301 Sec. 398. Notices to States regarding imported food. 399. Grants to enhance food safety. 399a. Office of the Chief Scientist. 399b. Office of Women’s Health. 399c. Improving the training of State, local, terri- torial, and tribal food safety officials. 399d. Employee protections. 399e. Nanotechnology. 399f. Ensuring adequate information regarding pharmaceuticals for all populations, par- ticularly underrepresented subpopulations, including racial subgroups. 399g. Food and Drug Administration Intercenter Institutes. 399h. National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufac- turing. 399i. Food and Drug Administration Working Cap- ital Fund. SUBCHAPTER I—SHORT TITLE § 301. Short title This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. (June 25, 1938, ch. 675, § 1, 52 Stat. 1040.) Statutory Notes and Related Subsidiaries EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro- vided that: ‘‘[SEC. 1] (a) The effective date of the following provi- sions of the Federal Food, Drug, and Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k) of this title]; 501(a), (4) [351(a)(4) of this title]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this title]. ‘‘(b) The Secretary of Agriculture shall promulgate regulations further postponing to July 1, 1940[,] the ef- fective date of the provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (

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

42 U.S.C. § 290ee — Opioid overdose reversal medication ac-

Page 934 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 290ee 1 So in original. Probably should be capitalized. or a hospital that receives disproportionate share hospital payments under section 1395ww(d)(5)(F) of this title. (B) The eligible entity is located in a State with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, as determined by the Direc- tor of the Centers for Disease Control and Prevention, or under the jurisdiction of an Indian Tribe with an age-adjusted rate of drug overdose deaths that is above the na- tional overdose mortality rate, as deter- mined through appropriate mechanisms as determined by the Secretary in consultation with Indian Tribes. (C) The eligible entity demonstrates that recovery coaches will be placed in both health care settings and community set- tings. (7) Period of grant A grant awarded to an eligible entity under this section shall be for a period of not more than 5 years. (c) Definitions In this section: (1) Indian Tribe; tribal organization The terms ‘‘Indian Tribe’’ and ‘‘tribal orga- nization’’ have the meanings given the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ in section 5304 of title 25. (2) Recovery coach the 1 term ‘‘recovery coach’’ means an indi- vidual— (A) with knowledge of, or experience with, recovery from a substance use disorder; and (B) who has completed training from, and is determined to be in good standing by, a recovery services organization capable of conducting such training and making such determination. (3) Recovery community organization The term ‘‘recovery community organiza- tion’’ has the meaning given such term in sec- tion 290ee–2(a) of this title. (d) Reporting Requirements (1) Reports by grantees Each el

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