{"database": "openregs", "table": "gao_reports", "rows": [["GAO-26-108623", "Drug Scheduling: While DEA Decisions Have Aligned with Recent HHS Recommendations, Both Need Comprehensive Policies", "2026-09-23", "GAO-26-108623", null, null, "What GAO Found\n\nUnder the Controlled Substances Act, substances that pose a risk of abuse and dependence are placed in categories\u2014referred to as schedules. To carry out certain scheduling actions, the Drug Enforcement Administration (DEA) is required to obtain a scheduling recommendation from the Department of Health and Human Services (HHS) based on a scientific and medical evaluation from the Food and Drug Administration (FDA). Evaluations and recommendations from HHS or DEA are not required for substances scheduled through legislation.\n\nOf the 208 substances for which DEA took scheduling actions from 2020 through 2025, DEA considered HHS evaluations and recommendations for all 95 substances for which they were required. Of those 95 substances, DEA\u2019s final scheduling decision aligned with HHS\u2019s recommendation for all 84 substances for which DEA had published a final rule as of December 31, 2025. The remaining 11 substances were still under extended temporary scheduling orders. We selected this timeframe to assess DEA scheduling actions during the most recent 6 calendar years.\n\nDEA and FDA have policies that address aspects of the scheduling process, including a memorandum of understanding (MOU) for sharing information; however, these policies have gaps. For example, DEA does not have policies that identify roles, responsibilities, and procedures related to scheduling. FDA does not have policies or procedures specifying how its staff are to conduct evaluations or develop recommendations. Developing such policies and procedures could help ensure operational consistency, especially if key personnel with longstanding subject matter expertise depart. The below figure shows DEA and FDA methods for coordinating regarding evaluations and recommendations for substances.\n\nFigure: DEA and FDA Methods for Coordinating Regarding Evaluations and Recommendations for Substances\n\n\n\nFDA has another MOU with the National Institutes of Health\u2019s (NIH) National Institute on Drug Abuse (NIDA) that describes procedures for FDA to consult NIDA when developing recommendations, but the MOU is over 40 years old and does not reflect the current entities involved or procedures. Without updating and regularly reviewing the MOU, FDA and NIDA staff may not know the entities and procedures to follow to ensure that NIDA\u2019s expertise about drug abuse informs scheduling recommendations.\n\nAccording to DEA and FDA officials, differences of scientific opinion between the two agencies about a substance\u2019s schedule have occurred rule but are rare. In such cases, they usually discuss their differences, share information, and resolve differences prior to soliciting public comments.\n\nWhy GAO Did This Study\n\nThe use of illicit drugs and misuse of prescription drugs has been a long-standing public health issue in the U.S. DEA, in consultation with HHS, may schedule such substances. Scheduling and quantity of a controlled substance control the extent to which criminal penalties under the Controlled Substances Act may be levied.\n\nMembers of Congress have raised questions about how DEA considers HHS evaluations and recommendations. This report identifies when DEA is required to request and consider HHS evaluations and recommendations, the extent to which DEA requested and considered HHS evaluations and recommendations for scheduling actions from 2020 through 2025, and the extent to which the agencies have related policies.\n\nGAO analyzed relevant statutes and regulations, available agency policies, and DEA and FDA data on substances for which DEA took scheduling actions. GAO analyzed regulatory dockets to validate and supplement data. GAO also interviewed officials from DEA and HHS, including FDA and NIH.", null, null, null, null, null, null, null, "https://www.gao.gov/products/gao-26-108623", null]], "columns": ["package_id", "title", "date_issued", "report_number", "document_type", "doc_class", "abstract", "subjects", "public_laws", "usc_references", "statute_references", "citation", "pdf_url", "html_url", "detail_url", "sudocs"], "primary_keys": ["package_id"], "primary_key_values": ["GAO-26-108623"], "units": {}, "query_ms": 0.32532098703086376, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}