FDA Extends Enforcement Deadline for Drug Supply Chain Security Act (DSCSA) Requirements | by: Sumeet Singh, Founder & Chairman | Article Posted: September 6, 2023 | Introduction The U.S. Food and Drug Administration (FDA) recently announced an extension on the...
Changes Rumored to Be on Horizon for DEA Suspicious Orders Public interest in the Opioid Epidemic has taken a back seat to this year’s events...
Vermont Updates Rules to Align Regulation with the DSCSA – And Then Some The DSCSA has had wide-ranging implications on state regulation of the...
DSCSA to Cause Future State Regulation Changes State regulation of the pharmaceutical supply chain is a patchwork of different definitions,...
Over two years in the making, the light at the end of the tunnel is finally in sight – the Drug Enforcement Administration’s (DEA) update to the infamous definition of a “suspicious order” may only be a few months away. In Fall 2017, the DEA drafted proposed an update to “to revise its regulations relating to suspicious orders of controlled substances,” per RIN 1117-AB47. The new rule will also further specify “the procedures a registrant must follow upon receiving such orders.”
DEA Consultant Receives Public Backlash & New Developments Demetra Ashley spent three decades at the DEA specializing in the diversion of...
FDA Begins DSCSA Enforcement on Distributors The first-time inspection of a wholesale drug distributor for DSCSA requirements is a warning to...
