As I was reviewing the public comments regarding the Drug Enforcement Administration’s (DEA’s) Notice of Proposed Rulemaking (NPRM) providing a much-needed update to the agency’s suspicious order regulations, I noticed a similar issue raised by multiple commenters.  Apart from the myriad of comments and requests seeking greater clarity from DEA on several definitions and provisions, there appears to remain a misunderstanding of using the 5% rule for distributions amongst practitioners.

Continue Reading Confusion Persists with the 5% Rule

More than four years ago, the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) was signed into law. CARA, among other things, includes provisions allowing for the partial filling of prescriptions for Schedule II controlled substances. On December 4, 2020, the Drug Enforcement Administration (“DEA”) published a Notice of Proposed Rulemaking (“NPRM”) implementing the partial fill provisions of CARA. While DEA does include additional provisions in the NPRM “to address certain regulatory requirements not addressed by the CARA[,]” the agency appears to have neglected to fully address circumstances when a prescription for a Schedule II is partially filled.
Continue Reading DEA Proposes Regulations for Partial Fills of C-IIs

Theft and Loss Reporting

On July 29, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) related to the reporting of thefts or significant losses of controlled substances.  Specifically, DEA proposes two changes to the reporting process:
Continue Reading DEA Proposes Changes to Theft/Loss Reporting and Finalizes New Registration Fees