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1 1 (April 6, 2021)

handle is hein.crs/govecxt0001 and id is 1 raw text is: Congressional ______ *.Research Service ~nforming the legislative d bate since 1914 An Expiration Date for Temporary Control of Fentanyl Analogues Updated April 6, 2021 In February 2020, the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act (the Act) temporarily placed certain fentanyl analogues-i.e., compounds chemically related to the powerful synthetic opioid fentanyl-on Schedule I of the Controlled Substances Act (CSA). The temporary scheduling of fentanyl analogues under the Act is slated to expire on May 6, 2021. In light of the approaching expiration, Congress may be interested in the legal issues related to the scheduling of fentanyl analogues. This Sidebar provides an overview of the legal framework that applies to fentanyl and its analogues, key considerations involved in scheduling fentanyl analogues, and options for pursuing scheduling via legislation. The CSA and Controlled Substance Regulation 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 classification into one of five lists, known as Schedules I through V. Controlled substances in Schedule I are subject to the most stringent controls, reflecting 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 have been deemed to 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 and individuals on ventilators. Multiple nonpharmaceutical substances chemically related to fentanyl are controlled in Schedule I. By contrast, cough medicines containing limited amounts of another 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. Congressional Research Service https://crsreports.congress.gov LSB10404 CRS Legal Sidebar Prepared for Members and Committees of Congress

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