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1 1 (June 12, 2019)

handle is hein.crs/govbaad0001 and id is 1 raw text is: Congressional Research Service Informing the legislative debate since 1914 S Updated June 12, 2019 Opioid Treatment Programs and Related Federal Regulations The use of opioid medications to treat opioid addiction is subject to federal regulations beyond those that apply to the same medications used for other purposes (e.g., treating pain). The medications methadone and buprenorphine are both opioids; their use to treat opioid addiction is often called opioid substitution therapy, opioid replacement therapy, or opioid agonist treatment. Federally certified opioid treatment programs (OTPs)-often called methadone clinics-offer these opioid medications in addition to counseling and other services for individuals addicted to heroin or other opioids. With few exceptions, the use of methadone to treat opioid addiction is limited to OTPs; however, physicians who wish to treat opioid addiction using buprenorphine may obtain a waiver to do so outside an OTP. A non-opioid medication used in the treatment of opioid addiction, naltrexone, may be used by OTPs, physicians with waivers, or anyone with the authority to write prescriptions. To understand how OTPs are regulated, it is helpful to have some background information about the medications used to treat opioid addiction and how each is regulated. Medication-Assisted Treatment (MAT) Medication-assisted treatment (MAT) is the combined use of medication and other services to treat addiction. Three medications are currently used in MAT for opioid addiction: methadone, buprenorphine, and naltrexone (naloxone, a medication used to reverse opioid overdose, is not used to treat opioid use disorders). Methadone Methadone is a full opioid agonist, meaning it binds to and activates opioid receptors in the brain. Methadone carries risk of abuse but is less addictive than some other full opioid agonists (e.g., heroin). Methadone suppresses withdrawal symptoms in detoxification therapy and controls the craving for opioids in maintenance therapy. Buprenorphine Buprenorphine is a partial opioid agonist, meaning it binds to opioid receptors in the brain and activates them, but not as much as full opioid agonists. Buprenorphine carries risk of abuse but is less addictive than methadone. Like methadone, buprenorphine is used for detoxification and maintenance therapy. Naltrexone Naltrexone is an opioid antagonist, meaning it binds to opioid receptors but does not activate them; it prevents opioid agonists from binding to and activating opioid receptors. Naltrexone carries no known risk of abuse. Naltrexone is used for relapse prevention because an individual on naltrexone who uses opioids will not experience the effects of that opioid. Regulatory Framework Two overlapping systems of federal law apply to MAT for opioid addiction: one regulating pharmaceuticals and the other regulating controlled substances. Federal Food, Drug, and Cosmetic Act (FFDCA) Under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.), the Food and Drug Administration (FDA) in the Department of Health and Human Services (HHS) has primary responsibility for ensuring the safety and effectiveness of pharmaceuticals, regardless of whether they are controlled substances. See CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness. Methadone, buprenorphine, and naltrexone are subject to the FFDCA. Controlled Substances Act (CSA) Under the Controlled Substances Act (CSA, 21 U.S.C. §§801 et seq.), the Drug Enforcement Administration (DEA) in the Department of Justice (DOJ) has primary responsibility for regulating the use of controlled substances for legitimate medical, scientific, research, and industrial purposes, and for preventing these substances from being diverted for illegal purposes. See CRS Report R45164, Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis. Methadone and buprenorphine are controlled under to the CSA. Naltrexone, which carries no known risk of abuse, is not controlled under the CSA. As shown in Table 1, methadone, buprenorphine, and naltrexone are classified differently under the CSA, which assigns various plants, drugs, and chemicals to one of five schedules based on accepted medical use, potential for abuse, and severity of potential psychological or physical dependence. Schedule I contains substances that have no currently accepted medical use and are not available by prescription (such as heroin). Schedules II, III, IV, and V include substances that have recognized medical uses and are progressively less dangerous and addictive. Table I. FDA-Approved Medications for Opioid MAT Medication Class CSA Schedule Methadone Full Opioid Agonist II Buprenorphine Partial Opioid Agonist Ill Naltrexone Opioid Antagonist none Source: Prepared by the Congressional Research Service based on information publicly available from FDA and DEA. https://crsreports.congr

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