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1 1 (April 9, 2020)

handle is hein.crs/govcuyx0001 and id is 1 raw text is: Researh Sevice COVID-19: The Drug Enforcement Administration's Regulatory Role April 9, 2020 The Coronavirus Disease 2019 (COVID-19) pandemic has caused strain on many health care and medical facilities around the country, and some doctors and pharmacists have altered conventional practice to accommodate the needs of patients during this public health emergency. Changed practices include maintaining increased supplies of Schedule 11 controlled substances needed for intubation at hospitals and increasing the use of telemedicine as an alternative to in-person patient visits with a provider. Such changes require the Drug Enforcement Administration (DEA) to make exceptions to Controlled Substances Act (CSA) regulatory requirements. DEA has made these arid other accommodations during the COVID- 19 public health emergency. This Insight focuses on DEA's regulatory role and how related polices have changed in response to the COVID- 19 pandemic. The Food and Drug Administration (FDA) also plays a significant role in regulating the nation's drug supply, but is only briefly mentioned here. See other CRS products for discussion of FDA policies. DEA's Regulatory Role In addition to criminal enforcement, DEA is charged with enforcing noncriminal regulatory requirements of the CSA. Those requirements provide the statutory framework through which the federal government regulates the lawful production, possession, and distribution of controlled substances. Certain CSA laws and regulations are associated with recent COVID- 19-related needs and changes. For a broader discussion of the CSA, see CRS Report R45948, The Controlled Substances Act (CSA): A Legal Overview for the 116th Congress. Registrants The CSA requires persons (such as drug manufacturers, wholesale distributors, physicians, pharmacists, and scientific researchers) who handle controlled substances or listed chemicals to register with the DEA. Among other CSA requirements, registrants must maintain detailed records of their controlled substance inventories, establish adequate security controls to minimize theft and diversion, and issue prescriptions according to requirements specific to schedule classification. Congressional Research Service https://crsreports.congress.gov IN11321 GRS }NStGHT Prepaed for Membeivs and Cornm ittees o4 Cor~qress ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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