A Little-Known Amphetamine Could Soon Join Schedule I
Published Date: 6/3/2025
Proposed Rule
Summary
The DEA wants to put 4-fluoroamphetamine (4-FA) into Schedule I, meaning it’s considered very risky and illegal to handle without strict rules. This affects anyone who makes, sells, studies, or possesses 4-FA, bringing serious legal consequences. You’ve got until July 3, 2025, to share your thoughts or ask for a hearing before this rule might become official.
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
4‑FA Proposed Placement in Schedule I
The DEA proposes to place 4‑fluoroamphetamine (4‑FA), including its salts, isomers, and salts of isomers, into Schedule I of the Controlled Substances Act. If finalized, 4‑FA would be treated as a Schedule I drug, meaning handling it (manufacture, distribution, research, import/export, or possession) would be subject to strict legal controls and sanctions.
Registration and Compliance Required to Handle 4‑FA
If the rule is finalized, anyone who wants to handle 4‑FA (manufacture, distribute, import, export, research, instructional use, chemical analysis, or possess it) must be registered with DEA under 21 U.S.C. 822, 823, 957, and 958 and follow rules in 21 CFR parts 1301–1312. Registered handlers would also need to meet Schedule I requirements such as security, labeling and packaging rules, manufacturing quota limits, inventories (initial and every two years), recordkeeping and ARCOS reporting, order form rules, and import/export compliance as of the effective date of a final scheduling action.
Immediate Disposal or Transfer Requirement for Unregistered Holders
People or entities that currently possess 4‑FA but do not have DEA registration would need to apply for registration and may not continue to handle 4‑FA as of the effective date of a final scheduling action unless the DEA has approved their registration. Those who do not obtain registration must surrender all quantities or transfer them to a DEA‑registered person before the effective date, and any remaining 4‑FA must be disposed of in accordance with 21 CFR part 1317 and other applicable laws.
Unauthorized Handling Subject to Sanctions
Any activity involving 4‑FA that is not authorized by the Controlled Substances Act or DEA regulations would be unlawful and may subject the person to administrative, civil, and/or criminal sanctions. This applies as of the effective date of a final scheduling action.
DEA Certifies Limited Small‑Entity Economic Impact
DEA reviewed the rule under the Regulatory Flexibility Act and certifies that placing 4‑FA in Schedule I is not expected to have a significant economic impact on a substantial number of small entities. The agency notes no evidence of significant diversion from legitimate suppliers and that 4‑FA is not a marketed drug in the U.S.
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Key Dates
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