§290ee Opioid overdose reversal medication access, education, and co-prescribing grant programs

The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, 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 section 301 of Title 21 and Tables.

2022—Pub. L. 117–328, § 1220(e), substituted “approved, cleared, or otherwise legally marketed” for “approved or cleared” wherever appearing. Pub. L. 117–328, § 1220(a)(1), substituted “access, education, and co-prescribing grant programs” for “access and education grant programs” in section catchline. Subsec. (a). Pub. L. 117–328, § 1220(a)(2), (3), substituted “Grants” for “Grants to States” in heading and “shall make grants to States, localities, Indian Tribes, and Tribal organizations (as those terms are defined in section 5304 of title 25)” for “shall make grants to States” in introductory provisions. Subsec. (a)(1). Pub. L. 117–328, § 1220(a)(4), substituted “implement strategies that increase access to drugs or devices” for “implement strategies for pharmacists to dispense a drug or device”. Subsec. (a)(3) to (5). Pub. L. 117–328, § 1220(a)(5), (6), added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively. Subsec. (d)(2). Pub. L. 117–328, § 1220(b), substituted “5 years” for “3 years”. Subsec. (d)(3). Pub. L. 117–328, § 1220(c), amended par. (3) generally. Prior to amendment, text read as follows: “A State may use not more than 20 percent of a grant under this section for educating the public pursuant to subsection (a)(4).” Subsec. (h)(1). Pub. L. 117–328, § 1220(d), substituted “fiscal years 2023 through 2027” for “fiscal years 2017 through 2019”.

References to Opioid Overdose Reversal Agents in HHS Grant Programs Pub. L. 119–44, title II, § 210, Dec. 1, 2025, 139 Stat. 682, provided that: “(a) In General.—The Secretary of Health and Human Services shall ensure that, as appropriate, whenever the Department of Health and Human Services issues a regulation or guidance for any grant program addressing opioid misuse and use disorders, any reference to an opioid overdose reversal drug (such as a reference to naloxone) is inclusive of any opioid overdose reversal drug that has been approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for emergency treatment of a known or suspected opioid overdose. “(b) Existing References.—“(1) Update.—Not later than one year after the date of enactment of this Act [Dec. 1, 2025], the Secretary of Health and Human Services shall update all references described in paragraph (2) to be inclusive of any opioid overdose reversal drug that has been approved or otherwise authorized for use by the Food and Drug Administration. “(2) References.—A reference described in this paragraph is any reference to an opioid overdose reversal drug (such as naloxone) in any regulation or guidance of the Department of Health and Human Services that—“(A) was issued before the date of enactment of this Act; and “(B) is included in—“(i) the grant program for State and Tribal response to opioid use disorders under section 1003 of the 21st Century Cures Act [former] (42 U.S.C. 290ee–3 note) [now 42 U.S.C. 290ee–3a] (commonly referred to as ‘State Opioid Response Grants’ and ‘Tribal Opioid Response Grants’); or “(ii) the grant program for priority substance use disorder prevention needs of regional and national significance under section 516 of the Public Health Service Act (42 U.S.C. 290bb–22).”