{ "id": "R45164", "type": "CRS Report", "typeId": "REPORTS", "number": "R45164", "active": false, "source": "EveryCRSReport.com", "versions": [ { "source": "EveryCRSReport.com", "id": 588968, "date": "2018-12-18", "retrieved": "2020-01-02T16:13:18.642861", "title": "Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis", "summary": "According to the Centers for Disease Control and Prevention, the annual number of drug overdose deaths involving prescription opioids (such as hydrocodone, oxycodone, and methadone) and illicit opioids (such as heroin and nonpharmaceutical fentanyl) has more than quadrupled since 1999. A November 2017 report issued by the President\u2019s Commission on Combating Drug Addiction and the Opioid Crisis also observed that \u201c[t]he crisis in opioid overdose deaths has reached epidemic proportions in the United States ... and currently exceeds all other drug-related deaths or traffic fatalities.\u201d How the current opioid epidemic happened, and who may be responsible for fueling it, are complicated questions, though reports suggest that several parties likely played contributing roles, including pharmaceutical manufacturers and distributors, doctors, health insurance companies, rogue pharmacies, and drug dealers and addicts. Many federal departments and agencies are involved in efforts to combat opioid abuse and addiction, including a law enforcement agency within the U.S. Department of Justice, the Drug Enforcement Administration (DEA), which is the focus of this report. \nThe primary federal law governing the manufacture, distribution, and use of prescription and illicit opioids is the Controlled Substances Act (CSA), a statute that the DEA is principally responsible for administering and enforcing. The CSA and DEA regulations promulgated thereunder establish a framework through which the federal government regulates the manufacture, distribution, importation, exportation, and use of certain substances which have the potential for abuse or psychological or physical dependence, including opioids. Congress enacted the CSA in 1970 to facilitate the availability of controlled substances for authorized medical, scientific, research, and industrial purposes, while also preventing these substances from being diverted out of legitimate channels for illegal purposes such as drug abuse and drug trafficking activities. The CSA aims to protect the public\u2019s health and safety from dangers posed by highly addictive or dangerous controlled substances that are diverted into the illicit market, while also ensuring that patients have access to pharmaceutical controlled substances for legitimate medical purposes such as the treatment of pain.\nThis report describes the current federal legal regime governing opioids and other controlled substances under the CSA and its implementing regulations, including (1) the classification of various plants, drugs, and chemicals into one of five schedules based on the substance\u2019s medical use, potential for abuse, and safety or dependence liability; (2) who must register with the DEA in order to receive authorization to handle the substances (such as drug manufacturers, wholesale distributors, doctors, hospitals, pharmacies, and scientific researchers); (3) what obligations registrants must satisfy in order to maintain a valid registration (such as keeping records of drug inventories and transactions, submitting reports to the DEA, and providing security measures to safeguard controlled substances); and (4) the DEA\u2019s administrative, civil, and criminal authorities for enforcing regulatory compliance with the CSA (such as suspending or revoking a registrant\u2019s legal authority to handle controlled substances if the DEA Administrator finds that the registrant has \u201ccommitted such acts as would render his registration ... inconsistent with the public interest.\u201d). The report then examines DEA initiatives and actions taken, pursuant to its legal authorities under the CSA, which specifically target the abuse of opioids. The report concludes by describing the legislative response to the opioid epidemic, including a summary of the amendments to the CSA made by legislation enacted by the 115th Congress, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (P.L. 115-271).", "type": "CRS Report", "typeId": "REPORTS", "active": false, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "https://www.crs.gov/Reports/R45164", "sha1": "48efc33660e1edc2b3c311e12c1bbded56b9c6f4", "filename": "files/20181218_R45164_48efc33660e1edc2b3c311e12c1bbded56b9c6f4.html", "images": {} }, { "format": "PDF", "encoding": null, "url": "https://www.crs.gov/Reports/pdf/R45164", "sha1": "ec63f46565f1bb71357592ff2b3250e35ee13fdf", "filename": "files/20181218_R45164_ec63f46565f1bb71357592ff2b3250e35ee13fdf.pdf", "images": {} } ], "topics": [] }, { "source": "EveryCRSReport.com", "id": 580190, "date": "2018-04-16", "retrieved": "2018-05-10T10:39:55.653923", "title": "Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis", "summary": "According to the Centers for Disease Control and Prevention, the annual number of drug overdose deaths involving prescription opioids (such as hydrocodone, oxycodone, and methadone) and illicit opioids (such as heroin and non-pharmaceutical fentanyl) has more than quadrupled since 1999. A November 2017 report issued by the President\u2019s Commission on Combating Drug Addiction and the Opioid Crisis also observed that \u201c[t]he crisis in opioid overdose deaths has reached epidemic proportions in the United States ... and currently exceeds all other drug-related deaths or traffic fatalities.\u201d How the current opioid epidemic happened, and who may be responsible for fueling it, are complicated questions, though reports suggest that several parties likely played contributing roles, including pharmaceutical manufacturers and distributors, doctors, health insurance companies, rogue pharmacies, and drug dealers and addicts. Many federal departments and agencies are involved in efforts to combat opioid abuse and addiction, including a law enforcement agency within the U.S. Department of Justice, the Drug Enforcement Administration (DEA), which is the focus of this report. \nThe primary federal law governing the manufacture, distribution, and use of prescription and illicit opioids is the Controlled Substances Act (CSA), a statute that the DEA is principally responsible for administering and enforcing. The CSA and DEA regulations promulgated thereunder establish a framework through which the federal government regulates the manufacture, distribution, importation, exportation, and use of certain substances which have the potential for abuse or psychological or physical dependence, including opioids. Congress enacted the CSA in 1970 to facilitate the availability of controlled substances for authorized medical, scientific, research, and industrial purposes, while also preventing these substances from being diverted out of legitimate channels for illegal purposes such as drug abuse and drug trafficking activities. The CSA aims to protect the public\u2019s health and safety from dangers posed by highly addictive or dangerous controlled substances that are diverted into the illicit market, while also ensuring that patients have access to pharmaceutical controlled substances for legitimate medical purposes such as the treatment of pain.\nThis report describes the current federal legal regime governing opioids and other controlled substances under the CSA and its implementing regulations, including (1) the classification of various plants, drugs, and chemicals into one of five schedules based on the substance\u2019s medical use, potential for abuse, and safety or dependence liability; (2) who must register with the DEA in order to receive authorization to handle the substances (such as drug manufacturers, wholesale distributors, doctors, hospitals, pharmacies, and scientific researchers); (3) what obligations registrants must satisfy in order to maintain a valid registration (such as keeping records of drug inventories and transactions, submitting reports to the DEA, and providing security measures to safeguard controlled substances); and (4) the DEA\u2019s administrative, civil, and criminal authorities for enforcing regulatory compliance with the CSA (such as suspending or revoking a registrant\u2019s legal authority to handle controlled substances if the DEA Administrator finds that the registrant has \u201ccommitted such acts as would render his registration ... inconsistent with the public interest.\u201d). The report then examines DEA initiatives and actions taken, pursuant to its legal authorities under the CSA, which specifically target the abuse of opioids. The report concludes by discussing selected opioid-related legislative proposals in the 115th Congress that would amend the CSA.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R45164", "sha1": "e64ba7e05d994bd366dcad1a3c7734ecac141546", "filename": "files/20180416_R45164_e64ba7e05d994bd366dcad1a3c7734ecac141546.html", "images": {} }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R45164", "sha1": "4a8df5c19a71abd0d245831f6036b7a17ccd9e19", "filename": "files/20180416_R45164_4a8df5c19a71abd0d245831f6036b7a17ccd9e19.pdf", "images": {} } ], "topics": [] } ], "topics": [ "Health Policy" ] }