42 U.S.C. § 290ee (THE PUBLIC HEALTH AND WELFARE)
§ 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) 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 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.
(July 1, 1944, ch. 373, title V, § 545, as added Pub. L. 114–198, title I, § 110(a), July 22, 2016, 130 Stat. 709; amended Pub. L. 117–328, div. FF, title I, § 1220, Dec. 29, 2022, 136 Stat. 5672.)
heading: Editorial Notes
heading: References in Text
text: 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.
heading: Prior Provisions
text: A prior section 290ee, act July 1, 1944, ch. 373, title V, § 545, formerly Pub. L. 92–255, title V, § 502, as added Pub. L. 94–237, § 12(b)(1), Mar. 19, 1976, 90 Stat. 247, and amended Pub. L. 95–461, § 5, Oct. 14, 1978, 92 Stat. 1269; Pub. L. 96–181, § 11, Jan. 2, 1980, 93 Stat. 1315; renumbered § 524 of act July 1, 1944, and amended Apr. 26, 1983, Pub. L. 98–24, § 2(b)(15), 97 Stat. 181; renumbered § 545, July 22, 1987, Pub. L. 100–77, title VI, § 611(2), 101 Stat. 516; Nov. 4, 1988, Pub. L. 100–607, title VIII, § 813(3), 102 Stat. 3170; Nov. 7, 1988, Pub. L. 100–628, title VI, § 613(3), 102 Stat. 3243; Aug. 16, 1989, Pub. L. 101–93, § 5(t)(1), 103 Stat. 615, which related to technical assistance to State and local agencies by the National Institute on Drug Abuse, was omitted in the general revision of this part by Pub. L. 102–321.
heading: Amendments
text: 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”.