Section text and notes
Establishment
In general
21 U.S.C. 301The Secretary shall award grants to eligible entities to expand access to drugs or devices approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [ et seq.] for emergency treatment of known or suspected opioid overdose.
Eligible entity
section 5304 of title 25For purposes of this section, the term “eligible entity” means a State, Territory, locality, or Indian Tribe or Tribal organization (as those terms are defined in ).
Subgrants
section 1395x(aa) of this titlesection 1603 of title 25For the purposes for which a grant is awarded under this section, the eligible entity receiving the grant may award subgrants to a Federally qualified health center (as defined in ), an opioid treatment program (as defined in section 8.2 of title 42, Code of Federal Regulations (or any successor regulations)), any practitioner dispensing narcotic drugs for the purpose of maintenance or detoxification treatment, or any nonprofit organization that the Secretary deems appropriate, which may include Urban Indian organizations (as defined in ).
Prescribing
Application
Use of funds
Improving access to overdose treatment
Information on best practices
Health and Human Services
21 U.S.C. 301The Secretary of Health and Human Services may provide information to States, localities, Indian Tribes, Tribal organizations, and Urban Indian organizations on best practices for prescribing or co-prescribing a drug or device approved, cleared, or otherwise legally marketed under the Federal Food, Drug, and Cosmetic Act [ et seq.] for emergency treatment of known or suspected opioid overdose, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.
Defense
The Secretary of Health and Human Services may, as appropriate, consult with the Secretary of Defense regarding the provision of information to prescribers within Department of Defense medical facilities on best practices for prescribing or co-prescribing 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, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.
Veterans Affairs
The Secretary of Health and Human Services may, as appropriate, consult with the Secretary of Veterans Affairs regarding the provision of information to prescribers within Department of Veterans Affairs medical facilities on best practices for prescribing or co-prescribing 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, including for patients receiving chronic opioid therapy and patients being treated for opioid use disorders.
Rule of construction
Nothing in this subsection shall be construed as establishing or contributing to a medical standard of care.
Evaluations by recipients
As a condition of receipt of a grant under this section, an eligible entity shall, for each year for which the grant is received, submit to the Secretary an evaluation of activities funded by the grant which contains such information as the Secretary may reasonably require.
Reports by the Secretary
Not later than 5 years after the date on which the first grant under this section is awarded, the Secretary shall submit to the appropriate committees of the House of Representatives and of the Senate a report aggregating the information received from the grant recipients for such year under subsection (e) and evaluating the outcomes achieved by the programs funded by grants awarded under this section.
Authorization of appropriations
There is authorized to be appropriated to carry out this section, $5,000,000 for the period of fiscal years 2023 through 2027.
July 1, 1944, ch. 373 Pub. L. 114–198, title I, § 107(a)130 Stat. 703 Pub. L. 117–215, title I, § 103(b)(3)(B)136 Stat. 2263 Pub. L. 117–328, div. FF, title I136 Stat. 5670–5672 (, title V, § 544, as added , , ; amended , , ; , §§ 1219(a)(1)–(7)(A), 1262(b)(4), , , 5682.)
Editorial Notes
References in Text
act June 25, 1938, ch. 675 52 Stat. 1040 section 301 of Title 21The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a)(1), (c)(1) to (4), and (d)(1), is , , which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see and Tables.
Prior Provisions
act July 1, 1944, ch. 373, title V, § 544 Pub. L. 91–616, title III, § 33384 Stat. 1853 Pub. L. 93–282, title I, § 122(a)88 Stat. 131 Pub. L. 94–581, title I, § 111(c)(4)90 Stat. 2852 Pub. L. 98–24, § 2(b)(13)97 Stat. 181 Pub. L. 99–401, title I, § 106(a)100 Stat. 907 Pub. L. 100–77, title VI, § 611(2)101 Stat. 516 Pub. L. 102–54, § 13(q)(1)(A)(ii)105 Stat. 278 Pub. L. 102–321section 290dd–2 of this titleA prior section 290dd–3, , formerly , , , as amended , , ; , , ; renumbered § 523 of act , , , ; , , ; renumbered § 544, , , ; , , , which related to confidentiality of patient records for alcohol abuse and alcoholism programs, was omitted in the general revision of this part by . See .
Amendments
Pub. L. 117–328, § 1219(a)(7)(A)2022—, substituted “approved, cleared, or otherwise legally marketed” for “approved or cleared” wherever appearing.
Pub. L. 117–328, § 1219(a)(1)Subsec. (a)(2). , (2), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: “A grant awarded under this section may not be for more than $200,000 per grant year.”
Pub. L. 117–328, § 1262(b)(4)section 823(g) of title 21Subsec. (a)(3). , substituted “any practitioner dispensing narcotic drugs for the purpose of maintenance or detoxification treatment” for “any practitioner dispensing narcotic drugs pursuant to ”.
Pub. L. 117–328, § 1219(a)(2)section 1395x(aa) of this titlesection 823(h) of title 21, added par. (3) and struck out former par. (3). Prior to amendment, text read as follows: “For purposes of this section, the term ‘eligible entity’ means a Federally qualified health center (as defined in ), an opioid treatment program under part 8 of title 42, Code of Federal Regulations, any practitioner dispensing narcotic drugs pursuant to , or any other entity that the Secretary deems appropriate.”
Pub. L. 117–215 substituted “823(h)” for “823(g)”.
Pub. L. 117–328, § 1219(a)(3)(A)Subsec. (a)(4)(A). , inserted “, including patients prescribed both an opioid and a benzodiazepine” after “overdose”.
Pub. L. 117–328, § 1219(a)(3)(B)Subsec. (a)(4)(D). , substituted “overdose” for “drug overdose”.
Pub. L. 117–328, § 1219(a)(4)Subsec. (c)(5). , amended par. (5) generally. Prior to amendment, par. (5) read as follows: “To establish protocols to connect patients who have experienced a drug overdose with appropriate treatment, including medication-assisted treatment and appropriate counseling and behavioral therapies.”
Pub. L. 117–328, § 1219(a)(5)(A)Subsecs. (d), (e). , (C), added subsec. (d) and redesignated former subsec. (d) as (e). Former subsec. (e) redesignated (f).
Pub. L. 117–328, § 1219(a)(5)(A)Subsec. (f). , (B), redesignated subsec. (e) as (f) and substituted “subsection (e)” for “subsection (d)”. Former subsec. (f) redesignated (g).
Pub. L. 117–328, § 1219(a)(5)(A)Subsec. (g). , (6), redesignated subsec. (f) as (g) and substituted “fiscal years 2023 through 2027” for “fiscal years 2017 through 2021”.
Statutory Notes and Related Subsidiaries
Funding for Community-Based Funding for Local Substance Use Disorder Services
Pub. L. 117–2, title II, § 2706135 Stat. 47
In General .—
Use of Funds.—
In general .—
Use of grant funds .—
Improving Access to Overdose Treatment
Pub. L. 114–198, title I, § 107(b)130 Stat. 705 Pub. L. 117–328, div. FF, title I, § 1219(a)(7)(B)136 Stat. 5672 , , , authorized Secretary of Health and Human Services to provide information to prescribers within certain Federal health facilities on best practices for prescribing or co-prescribing drugs or devices for emergency treatment of opioid overdose, prior to repeal by , , . See subsec. (d) of this section.