The Drug Enforcement Administration proposes to revoke the exempted prescription product status for all butalbital products previously granted exemptions. Upon publication of a final rule, these products shall become subject to all schedule III controls under the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule III controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess) or propose to handle butalbital products. This rulemaking also proposes to make changes to our regulations to clarify that DEA may revoke "(either individually or categorically)" any previously granted exemptions, and adds regulations to clarify that products exempted from application of all or any part of the Controlled Substances Act are listed in the Table of Exempted Prescription Products available on the DEA Diversion Control website (https://www.deadiversion.usdoj.gov/).
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