Pharmacy Practice FAQsBUTALBITAL PRODUCTS Q: Have butalbital products presently exempted from scheduling under the federal Controlled Substances Act been moved to Schedule III? A: At present, exempted butalbital products remain exempted. The federal Drug Enforcement Administration has, however, published a proposed rule that, if adopted, would revoke the exempted prescription product status for all butalbital products previously granted exemptions. If the rule is adopted, these products will become subject to all schedule III controls under the Controlled Substances Act, and 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. DEA’s proposed rule is found here:
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