This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more
2/9/2024
/ Controlled Substances ,
DEA ,
Drug Distribution ,
Enforcement Actions ,
Food & Drug Regulations ,
Healthcare ,
Judicial Review ,
Order to Show Cause ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Public Safety ,
Settlement ,
Suspensions
On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more
9/6/2023
/ Controlled Substances ,
DEA ,
Final Rules ,
Food and Drug Administration (FDA) ,
Inventory ,
Life Sciences ,
Manufacturers ,
Notice of Proposed Rulemaking (NOPR) ,
Pharmaceutical Industry ,
Procurement Guidelines ,
Product Development Protocols ,
Product Labels ,
Quotas ,
Schedule I Drugs ,
Supply Chain
Over the last decade, the increased use of Controlled Substance Ordering System (“CSOS”) applications (i.e., platforms used to electronically transmit controlled substance orders) and Electronic Prescriptions for Controlled...more
On June 22, 2023, DEA published a final rule regarding the timing with which registrants are required to report the theft or loss of controlled substances (the “Final Rule”). 88 FR 40707. DEA’s regulations have always...more
On May 26, 2023, the Drug Enforcement Administration (DEA) published a final decision and order (the “Final Order”) affirming an Administrative Law Judge's (ALJ) August 29, 2019 recommendation (the “ALJ Order”) to revoke DEA...more
5/31/2023
/ Controlled Substances ,
DEA ,
Department of Justice (DOJ) ,
Drug & Alcohol Abuse ,
Enforcement Actions ,
Healthcare ,
License Suspensions ,
Opioid ,
Order to Show Cause ,
Pharmaceutical Industry ,
Preliminary Injunctions ,
Prescription Drugs
On December 29, 2022, the Consolidated Appropriations Act of 2023 (Public Law No. 117-328) (the “Legislation”) was signed into law, which, under Section 1262 of the Legislation, contains the Mainstreaming Addiction Treatment...more