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1 1 (February 7, 2020)

handle is hein.crs/govcagw0001 and id is 1 raw text is: Scheduling of Fentanyl Analogues: The New Legal Landscape February 7, 2020 In the most recent change to federal law in response to the opioid crisis, on February 6, 2020, the President signed the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act (the Act). The Act temporarily extended a Drug Enforcement Administration (DEA) administrative order that placed certainfentanyl analogues-i.e., compounds related to the powerful synthetic opioid fentanyl-under control pursuant to the Controlled Substances Act (CSA). This Sidebar provides an overview of key legal issues related to the scheduling of fentanyl analogues and recent changes to the law. The CSA and Controlled Substance Scheduling The CSA regulates drugs and other substances-whether medical or recreational, legally or illicitly distributed-that pose a risk of abuse and dependence. Substances become subject to the CSA through placement in one of five lists, known as Schedules I through V A lower schedule number carries greater restrictions, so controlled substances in Schedule I are subject to the most stringent controls. Placement in Schedule I reflects a finding that a substance has a high potential for abuse and no currently accepted medical use. Substances in Schedules II through V have accepted medical uses and pose progressively lower risks of abuse and dependence. Fentanyl itself is in Schedule II, as it has recognized medical uses such as pain management for cancer patients. Multiple nonpharmaceutical substances related to fentanyl are controlled in Schedule I. Cough medicines containing limited amounts of the opiate codeine are in Schedule V. (Many other prescription drugs are not controlled substances subject to the CSA.) A substance not specifically designated for control in Schedules I through V may still be subject to the CSA as a controlled substance analogue. A controlled substance analogue is a substance not otherwise approved by the Food and Drug Administration (FDA) or scheduled under the CSA that has (1) a chemical structure substantially similar to that of a controlled substance in Schedule I or II, or (2) an actual or intended effect that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect ... of a controlled substance in schedule I or II. A substance that meets those criteria and is intended for human consumption is treated as a controlled substance in Schedule i. Synthetic opioids related to fentanyl may qualify as controlled substance analogues. However, as a practical matter, treatment as controlled substance analogues may allow for less effective control than if Congressional Research Service https://crsreports.congress.gov LSB10404 CRS Lega Sidebar Prepaed for Membeivs and Cornm ittees o4 Cor~qress ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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