Justice Department, Drug Enforcement Administration
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/).
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Justice Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-384] RIN 1117-AB75 AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice of proposed rulemaking. SUMMARY: 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/​ ). DATES: Comments must be submitted electronically or postmarked on or before May 12, 2022. ADDRESSES: Interested persons may file written comments on this proposal in accordanc…
Citation: 87 FR 21588
