DEA Moves to Tighten Grip on Another New Drug
Published Date: 5/26/2026
Proposed Rule
Summary
The DEA wants to put diphenidine, a drug, into Schedule I, which means it will be treated like the most tightly controlled substances. This change affects anyone who makes, sells, studies, or owns diphenidine, adding strict rules and penalties. You’ve got until June 25, 2026, to share your thoughts before the new rules might kick in.
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
Diphenidine Placed in Schedule I
DEA proposes to place diphenidine (including its salts and isomers) in Schedule I of the Controlled Substances Act. If finalized, anyone who handles or proposes to handle diphenidine—manufacturers, distributors, importers, exporters, researchers, or possessors—will be subject to the full regulatory controls, and administrative, civil, and criminal sanctions that apply to Schedule I substances.
Unauthorized Possession and Penalties
Possession of diphenidine in any quantity in a manner not authorized by the CSA would be unlawful and could subject a person to prosecution under the CSA. Persons unwilling or unable to obtain DEA registration must surrender or transfer all quantities of diphenidine to a DEA-registered person before the effective date of any final scheduling action.
DEA Registration Required to Handle
If the rule is finalized, any person who handles diphenidine would need to be registered with DEA under 21 U.S.C. 822, 823, 957, and 958 and 21 CFR parts 1301 and 1312. Persons who currently handle diphenidine and are not registered may not continue to handle it unless DEA approves their registration; a person already registered to conduct research with another Schedule I substance may continue research on diphenidine only if they submit a completed application or modification not later than 90 calendar days after the date the final rule takes effect.
New Security, Recordkeeping, and Quota Rules
Registered handlers of diphenidine would need to meet Schedule I security requirements, labeling and packaging rules, quota-based manufacturing limits, inventory and biennial inventory requirements, specific records and reports (including automated reporting), and DEA order form and import/export rules as set out in 21 U.S.C. and 21 CFR parts cited in the proposal. Disposal of stocks must comply with 21 CFR part 1317 and other applicable laws.
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Key Dates
Department and Agencies
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