The Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to “revoke the exempted prescription product status for all butalbital products previously granted exemptions.”
If finalized as proposed, the significant impact of this change will be felt throughout the pharmaceutical supply chain.
The Controlled Substances Act and DEA’s regulations provide the agency with authority to exempt a prescription drug product containing a controlled substance from regulatory requirements and administrative, civil, and criminal sanctions. DEA is authorized, among other reasons, to exempt nonnarcotic prescription drug products from application of all or any part of the CSA if the product also contains one or more active ingredients which are not controlled substances and in such quantities “as to vitiate the potential for abuse.“
Continue Reading DEA to Remove Exemptions for All Butalbital Products