II 118th CONGRESS 1st Session S. 1785 IN THE SENATE OF THE UNITED STATES May 31 (legislative day, May 30), 2023 Mr. Markey (for himself, Ms. Warren , Mr. Booker , Mr. Carper , Mr. Wyden , Mr. Welch , Mr. Menendez , Mr. Merkley , Mr. Blumenthal , and Mr. Heinrich ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish programs to address addiction and overdoses caused by illicit fentanyl and other opioids, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Stop Fentanyl Overdoses Act of 2023 . (b) Table of contents The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Definitions. TITLE I—Fentanyl Sec. 101. Enhanced fentanyl surveillance. Sec. 102. Collection of overdose data. Sec. 103. Public health support for law enforcement. Sec. 104. Fentanyl detection. Sec. 105. Grants to improve public health surveillance in forensic laboratories. TITLE II—Stemming the Supply of Fentanyl Sec. 201. Report on countries that produce synthetic drugs. Sec. 202. GAO report on international mail and cargo screening. TITLE III—Overdose prevention and substance use disorder treatment programs Sec. 301. Opioid treatment education. Sec. 302. GAO study on naloxone access. Sec. 303. Increasing access to medication for opioid overdose reversal; exemption from requirements of the Drug Supply Chain Security Act. Sec. 304. Grant program on harms of drug misuse. Sec. 305. Good Samaritan immunity. Sec. 306. Report on overdose prevention centers. Sec. 307. Prisons and substance use disorder treatment. 2. Definitions In this Act: (1) Fentanyl-related substance The term fentanyl-related substance has the meaning given the term in section 1308.11(h)(30)(i) of title 21, Code of Federal Regulations (or successor regulations). (2) Secretary The term Secretary means the Secretary of Health and Human Services. I Fentanyl 101. Enhanced fentanyl surveillance (a) CDC surveillance program Part J of title III of the Public Health Service Act is amended by inserting after section 392A ( 42 U.S.C. 280b–1 ) the following: 392B. Enhanced fentanyl surveillance (a) Definition In this section, the term fentanyl-related substance has the meaning given the term in section 1308.11(h)(30)(i) of title 21, Code of Federal Regulations (or successor regulations). (b) Data collection The Director of the Centers for Disease Control and Prevention shall enhance the Overdose Data to Action program and other drug surveillance programs of the Centers for Disease Control and Prevention by— (1) encouraging States, political subdivisions of States, and territories to participate in such programs; (2) increasing and accelerating the collection of data on fentanyl, fentanyl-related substances, other synthetic opioids, and new emerging drugs of abuse (including harmful adulterants of fentanyl, such as xylazine), including the collection of related overdose data from medical examiners and drug treatment admissions and information regarding drug seizures; and (3) utilizing available and emerging information on fentanyl, fentanyl-related substances, other synthetic opioids, and new emerging drugs of abuse, including information from— (A) the High Intensity Drug Trafficking Areas program under section 707 of the Office of National Drug Control Policy Reauthorization Act of 1998; (B) the National Drug Early Warning System; (C) State and local public health authorities; (D) Federal, State, and local public health laboratories; and (E) drug seizures by Federal, State, and local law enforcement agencies, including information from the National Seizure System and the National Forensic Laboratory Information System of the Drug Enforcement Administration. (c) Information sharing The Director of the Centers for Disease Control and Prevention shall publicly disseminate data collected under this section. (d) Authorization of appropriations There are authorized to be appropriated to carry out this section such sums as are necessary. . (b) Law enforcement reporting Each Federal law enforcement agency shall report information on all drug seizures by that agency to the Drug Enforcement Administration for inclusion in the National Seizure System. (c) GAO report Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall— (1) publish a report analyzing how Federal agencies can improve their collection, reporting, sharing, and analytic use of drug seizure data across Federal agencies and with States and local governments; and (2) include in such report an analysis of how well available data on drug seizures can measure progress toward reducing drug trafficking into and within the United States, as outlined in strategies such as the National Drug Control Strategy of the Office of National Drug Control Policy. 102. Collection of overdose data (a) In general Not later than 2 years after the date of enactment of this Act, the Secretary shall commence a study on how to most efficiently track overdoses by type of drug, including fentanyl. (b) Grant program (1) In general Upon completion of the study under subsection (a), and taking into consideration the results of such study, the Secretary shall award grants to States to facilitate the collection of data with respect to fentanyl-involved overdoses. (2) Requirement As a condition on receipt of a grant under this subsection, an applicant shall agree to share the data collected pursuant to the grant with the Centers for Disease Control and Prevention. (3) Preference In awarding grants under this subsection, the Secretary shall give preference to applicants whose grant proposals demonstrate the greatest need for collecting timely and accurate data on overdoses. 103. Public health support for law enforcement (a) Support for fentanyl detection and handling The Secretary, in consultation with the Attorney General, shall carry out a program to provide to Federal, State, and local law enforcement agencies training on accurate information about fentanyl and how to detect and handle fentanyl. (b) Evidence-Based The program under subsection (a) shall comply with evidence-based guidelines, including the Fentanyl Safety Recommendations for First Responders (or any successor guidelines) of the Office of National Drug Control Policy. 104. Fentanyl detection (a) Testing of contaminants The Secretary, acting through the Assistant Secretary for Mental Health and Substance Use, and in coordination with the Director of the Centers for Disease Control and Prevention, shall continue to improve efforts to enhance screening and identification of contaminants in drugs to prevent overdoses. (b) Research into technologies (1) Definition of chemical screening device In this subsection, the term chemical screening device means an infrared spectrophotometer, mass spectrometer, nuclear magnetic resonance spectrometer, Raman spectrophotometer, ion mobility spectrometer, or any other device or other technology that is able to determine the presence of, or identify, one or more contaminants in drugs. (2) Research The Secretary shall conduct or support research for the development or improvement of portable and affordable technologies relating to testing drugs for fentanyl and fentanyl-related substances, including chemical screening device methods. (3) Authorization of appropriations There are authorized to be appropriated to carry out this subsection such sums as are necessary. 105. Grants to improve public health surveillance in forensic laboratories Title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10101 et seq. ) is amended by adding at the end the following: PP Confronting the use of heroin, fentanyl, and associated synthetic drugs 3061. Authority to make grants to address public safety through improved forensic laboratory data (a) Purpose The purpose of this section is to assist States and units of local government in— (1) carrying out programs to improve surveillance of heroin, fentanyl, fentanyl-related substances, and associated synthetic drugs to enhance public health; (2) improving the ability of States, Tribes, and units of local government to carry out such programs; and (3) carrying out the activities as described in section 101 of the STOP Fentanyl Act of 2023 . (b) Grant authorization The Attorney General, acting through the Director of the Bureau of Justice Assistance, may make grants to States and units of local government to improve surveillance of heroin, fentanyl, fentanyl-related substances, and associated synthetic drugs to enhance public health. (c) Grant projects To improve surveillance of seized heroin, fentanyl, and associated synthetic drugs Grants made under subsection (b) shall be used for programs, projects, and other activities to— (1) reimburse State, local, or forensic science laboratories to help address backlogs of untested samples of heroin, fentanyl, and associated synthetic drugs; (2) reimburse State, local, or other forensic science laboratories for procuring equipment, technology, or other support systems if the applicant for the grant demonstrates to the satisfaction of the Attorney General that expenditures for such purposes would result in improved efficiency of laboratory testing and help prevent future backlogs; (3) reimburse State, local, or other forensic science laboratories for improved, real time data exchange with the Centers for Disease Control and Prevention on fentanyl, fentanyl-related substances, and other associated synthetic drugs present in the local communities; and (4) support State, tribal, and local health department services deployed to address the use of heroin, fentanyl, and associated synthetic drugs. (d) Limitation Not less than 60 percent of the amounts made available to carry out this section shall be awarded for the purposes under paragraph (1) or (2) of subsection (c). (e) Authorization of appropriations There are authorized to be appropriated to carry out this section such sums as are necessary. (f) Allocation (1) Population allocation Seventy-five percent of the amount made available to carry out this section in a fiscal year shall be allocated to each State that meets the requirements of section 2802 so that each State shall receive an amount that bears the same ratio to the 75 percent of the total amount made available to carry out this section for that fiscal year as the population of the State bears to the population of all States. (2) Discretionary allocation Twenty-five percent of the amount made available to carry out this section in a fiscal year shall be allocated pursuant to the discretion of the Attorney General for competitive grants to States or units of local government with high rates of primary treatment admissions for polysubstance use, including heroin and other opioids, for use by State or local law enforcement agencies. (3) Minimum requirement Notwithstanding paragraphs (1) and (2), each State shall receive not less than 0.6 percent of the amount made available to carry out this section in each fiscal year. (4) Certain territories (A) In general For purposes of the allocation under this section, American Samoa and the Commonwealth of the Northern Mariana Islands shall be considered as 1 State. (B) Allocation amongst certain territories For purposes of subparagraph (A), 67 percent of the amount allocated shall be allocated to American Samoa and 33 percent shall be allocated to the Commonwealth of the Northern Mariana Islands. . II Stemming the Supply of Fentanyl 201. Report on countries that produce synthetic drugs Not later than 1 year after the date of enactment of this Act, the Secretary of State shall submit to the Committee on the Judiciary and the Committee on Foreign Relations of the Senate and the Committee on Energy and Commerce of the House of Representatives a report— (1) identifying the countries the Secretary determines are the principal producers of synthetic drugs trafficked into the United States; (2) assessing how and why those countries are producing such drugs; and (3) describing measures the Secretary plans to take to reduce the flow of such drugs into the United States. 202. GAO report on international mail and cargo screening Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report reviewing the impact of the High Intensity Drug Trafficking Areas program on illicit fentanyl and fentanyl-related substances imported through international mail and cargo, including discussion of the following: (1) The volume of fentanyl and fentanyl-related substances being imported into the United States by means of international mail and cargo. (2) The potential impact of increased screening for illicit fentanyl and fentanyl-related substances on— (A) deterring drug trafficking in the United States; (B) interdicting fentanyl and fentanyl-related substances that were manufactured outside of the United States and intended, or attempted, to be imported into the United States; (C) the number of Federal criminal prosecutions based on the manufacture, distribution, or possession of fentanyl or fentanyl-related substances, disaggregated by demographic data, including sex, race, and ethnicity, of the offender; (D) the charges brought in such prosecutions; (E) the impacts of prosecutions on reducing demand and availability to users; and (F) the development of new fentanyl-related substances. (3) The need for noninvasive technology in screening for fentanyl and fentanyl-related substances, taking into account the findings pursuant to paragraphs (1) and (2). III Overdose prevention and substance use disorder treatment programs 301. Opioid treatment education Part D of title V of the Public Health Service Act ( 42 U.S.C. 290dd et seq. ) is amended by adding at the end the following: 553. Opioid treatment education (a) In general The Secretary shall award grants to States and local governmental entities to provide education to stakeholders, including health care providers, criminal justice professionals, and substance use disorder treatment personnel, on the current state of research on treatment for opioid use disorder, including— (1) the use of opioid agonists or partial agonists; and (2) the potential benefits of the use of opioid agonists or partial agonists for affected individuals. (b) Report Not later than 1 year after the date of enactment of the STOP Fentanyl Act of 2023 , the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes the following data on the education programs funded pursuant to grants under subsection (a): (1) The number of people reached by educational materials funded pursuant to grants under subsection (a). (2) The geographic areas where people received such educational materials. (3) The remaining populations and areas targeted for awareness of such educational materials, including the characteristics of such populations and areas, such as the type of stakeholder. (4) The outcomes of education provided pursuant to grants under subsection (a), as determined by the Secretary. (c) Authorization of appropriations There are authorized to be appropriated to carry out this section such sums as are necessary. . 302. GAO study on naloxone access (a) In general The Comptroller General of the United States shall conduct a study on actions that may be taken to ensure appropriate access and affordability of naloxone for individuals seeking to purchase naloxone. Such study shall address what is known about— (1) coverage of naloxone (in any available form), including whether naloxone can be covered as an over-the-counter drug under a group health plan or group or individual health insurance coverage (as such terms are defined in section 2791 of the Public Health Service Act ( 42 U.S.C. 300gg–91 )) or for individuals entitled to benefits under part A or enrolled under part B of title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq. ), or receiving medical assistance under a State plan under title XIX of such Act ( 42 U.S.C. 1396 et seq. ) or a waiver of such plan; (2) the out-of-pocket cost to consumers purchasing naloxone— (A) with a prescription, with and without coverage under any such plan or coverage; (B) over-the-counter, with and without coverage under any such plan or coverage; and (C) via standing order; and (3) other factors impacting coverage, including barriers in covering naloxone as an over-the-counter drug, the relative net costs of naloxone when purchased over-the-counter without insurance coverage compared to when purchased with a prescription and covered under a group health plan or health insurance coverage, and the availability of naloxone purchased and distributed through public health entities. (b) Report Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report that contains the findings of the study conducted under subsection (a). 303. Increasing access to medication for opioid overdose reversal; exemption from requirements of the Drug Supply Chain Security Act (a) Transactions Section 581(24)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360eee(24)(B) ) is amended— (1) by redesignating clauses (xvii) and (xviii) as clauses (xviii) and (xix), respectively; and (2) by inserting after clause (xvi) the following: (xvii) the distribution of an opioid antagonist indicated for emergency treatment of opioid overdose, such as naloxone, by or to an overdose prevention, syringe services program, or other harm reduction service; . (b) Wholesale distribution Section 503(e)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(e)(4) ) is amended— (1) by redesignating subparagraphs (R) and (S) as subparagraphs (S) and (T), respectively; and (2) by inserting after subparagraph (Q) the following: (R) the distribution of an opioid antagonist indicated for emergency treatment of opioid overdose, such as naloxone, by or to an overdose prevention, syringe services program, or other harm reduction service; . 304. Grant program on harms of drug misuse Part D of title V of the Public Health Service Act ( 42 U.S.C. 290dd et seq. ) (as amended by section 301) is amended by adding at the end the following: 554. Grant program on harms of drug misuse (a) In general The Assistant Secretary, in consultation with the Director of the Centers for Disease Control and Prevention, shall award grants to States and political subdivisions of States to support the delivery of overdose prevention services, including distribution of opioid reversal agents approved by the Food and Drug Administration, such as naloxone, fentanyl strips, and other harm reduction services that address the harms of drug misuse, including by— (1) connecting individuals at risk for, or with, a substance use disorder to overdose education, counseling, and health education; and (2) encouraging such individuals to take steps to reduce the harms associated with substance misuse. (b) Considerations In awarding grants under this section, the Assistant Secretary shall prioritize grants to applicants that are— (1) organizations providing culturally competent care in terms of considerations based on race, language, ethnicity, gender, sexuality, or disability; or (2) proposing to serve areas with— (A) a higher proportion of the population who meet criteria for dependence on, or abuse of, illicit drugs; (B) a higher drug overdose death rate; and (C) a greater behavioral health and substance use disorder workforce need. (c) Special considerations A recipient of a grant under this section shall— (1) ensure that not less than 60 percent of the grant funds are used for harm reduction programs; and (2) prioritize the delivery of opioid antagonists to— (A) people who use opioids or illicit drugs; (B) families of such people; (C) first responders, such as law enforcement personnel and nonemergency services, such as firefighters and park rangers; and (D) community service providers, such as library, school, and public transportation personnel. (d) Use of grant awards A recipient of a grant under this section may use grant funds for the following: (1) Adapting, maintaining, and expanding essential services provided by harm reduction service organizations to address the risks of drug overdose and contraction of infectious disease. (2) Maintaining or hiring staff. (3) Supporting program operational costs, including staff, rent, and vehicle purchase or maintenance. (4) Program supplies. (5) Support and case management services. (e) Authorization of appropriations There are authorized to be appropriated to carry out this section such sums as are necessary. . 305. Good Samaritan immunity (a) In general Part B of title II of the Public Health Service Act ( 42 U.S.C. 238 et seq. ) is amended by adding at the end the following: 249. Good Samaritan immunity (a) Limitation on civil liability for individuals who administer opioid overdose reversal drugs (1) In general Notwithstanding any other provision of law, except as provided in paragraph (2), no individual shall be liable in any Federal or State proceeding for harm caused by the emergency administration of an opioid overdose reversal drug to an individual who has or reasonably appears to have suffered an overdose from heroin or another opioid, if the individual administers the opioid overdose reversal drug in good faith. (2) Exception Paragraph (1) shall not apply to an individual if the harm was caused by the gross negligence or reckless misconduct of the individual who administers the drug. (3) Definition of opioid overdose reversal drug In this subsection, the term opioid overdose reversal drug means a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act that is indicated for the partial or complete reversal of the pharmacological effects of an opioid overdose in the human body. (b) Immunity from liability (1) Immunity (A) In general An individual described in subparagraph (B) shall not be cited, arrested, prosecuted, criminally liable, or subject to any sanction for a violation of a condition of supervised release under section 404 of the Controlled Substances Act for the possession or use of a controlled substance, or under any other provision of Federal law regulating the misuse of prescription drugs, as a result of seeking medical assistance as described in clause (i), (ii), or (iii) of subparagraph (B). (B) Individual described An individual referred to in subparagraph (A) is an individual who, in good faith and in a timely manner— (i) seeks medical assistance for another individual who is experiencing a drug overdose; (ii) seeks medical assistance for himself or herself for a drug overdose; or (iii) is the subject of a request for medical assistance for another individual who is experiencing a drug overdose. (2) Preemption This subsection preempts the laws of a State or any political subdivision of a State to the extent that such laws are inconsistent with this subsection, unless such laws provide greater protection from liability. (3) Definitions In this section: (A) Controlled substance The term controlled substance has the meaning given the term in section 102 of the Controlled Substances Act. (B) Drug overdose The term drug overdose means an acute condition resulting from or believed to be resulting from the use of a controlled substance, which an individual, who is not a health care professional, would reasonably believe requires medical assistance. (C) Prescription drug The term prescription drug means a drug subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act. (D) Seeks medical assistance; seeking medical assistance The terms seeks medical assistance and seeking such medical assistance include— (i) reporting a drug or alcohol overdose or other medical emergency to a law enforcement authority, the 9–1–1 system, a poison control center, or a medical provider; (ii) assisting another individual who is making a report described in clause (i); or (iii) providing care by administering a drug to someone who is experiencing a drug or alcohol overdose or other medical emergency while awaiting the arrival of medical assistance. . (b) Public awareness campaign The Secretary, in coordination with the Administrator of the Drug Enforcement Administration, shall carry out a campaign to increase public awareness of the limitations on civil and criminal liability established by section 249 of the Public Health Service Act (as added by subsection (a)). 306. Report on overdose prevention centers The Secretary shall enter into an agreement with the National Academies of Sciences, Engineering, and Medicine under which the National Academies shall— (1) not later than 2 years after the date of the agreement, submit to Congress a report on overdose prevention centers; and (2) include in the report required under paragraph (1)— (A) identification of barriers to operating overdose prevention centers; (B) a compilation of the data available to measure effectiveness of overdose prevention centers on preventing and reducing regional rates of overdose deaths, and practices utilized at overdose prevention centers to improve access to medication for opioid use disorder and recovery services; (C) identification of best practices at overdose prevention centers to promote individual and public health, provide resources to individuals and families, improve access to substance use disorder and behavioral health services, and reduce stigma; (D) recommendations for developing integrated care settings inclusive of overdose prevention sites and incorporating overdose prevention sites into referral networks; and (E) recommended approaches to overdose prevention services that may serve as effective strategies for recovery for people using fentanyl, fentanyl-related substances, other synthetic opioids, and new emerging drugs of abuse (including harmful adulterants of fentanyl, such as xylazine). 307. Prisons and substance use disorder treatment (a) Prisons and medication-Assisted treatment (1) In general The Director of the Bureau of Prisons, in collaboration with the Director of the Office of National Drug Control Policy, shall establish a program to offer— (A) all drugs that are approved by the Food and Drug Administration for treatment of a substance use disorder; (B) counseling and other psychosocial treatments for the treatment of substance use disorder; and (C) evidence-based withdrawal management services to individuals in the custody of the Bureau of Prisons to provide a comprehensive treatment approach substance use disorders. (2) Authorization of appropriations There are authorized to be appropriated to carry out this subsection such sums as are necessary. (b) Residential substance abuse treatment for State prisoners Section 1904(d) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 ( 34 U.S.C. 10424(d) ) is amended— (1) by striking means and inserting the following: (1) means ; (2) by striking the period at the end and inserting ; and ; and (3) by adding at the end the following: (2) includes any such course of comprehensive individual and group substance abuse treatment services using medication-assisted treatment for opioid use disorder (including the use of any drug approved or licensed by the Food and Drug Administration for such treatment). .