Karla Palmer and Andrew Hull will be presenting at this year’s Controlled Substances and State Regulatory Conference to be held in Savannah, GA, from September 3-5. Karla Palmer will be presenting on suspicious order monitoring and customer due diligence requirements for manufacturers and distributors as …
Like death and taxes, unannounced, periodic cyclic inspections of controlled substance manufacturers, distributors, importers, exporters, and narcotic treatment programs, by Drug Enforcement Administration (“DEA”) diversion investigators every three to five years is inevitable. “Practitioner” registrants, that include hospitals, pharmacies, and practitioners, are also subject to …
Hyman, Phelps & McNamara, P.C.’s John Gilbert will be speaking at the Demand Forecasting for Controlled Substances Hybrid Public Meeting sponsored by the Reagan-Udall Foundation for the FDA, Washington, DC. on August 27, 2025. The meeting is from 2-5pm (eastern) and includes both in-person and …
Earlier this week, we posted on the retirement of DEA Chief Administrative Law Judge Judge John J. Mulrooney, II, and the lack of appointed DEA ALJs to hear DEA cases upon his retirement, effective August 1. On a related note, HPM wants to take a …
Last week, DEA registrants and applicants with pending actions before DEA’s Office of Administrative Law Judges (OALJ) received an order from Chief Administrative Law Judge John J. Mulrooney, II, staying the hearing proceedings in those cases. In those orders, Chief Judge Mulrooney announced that he …
The diversion of controlled substances intended for patients by physicians, pharmacists, nurses and other trusted healthcare employees is a significant issue facing hospitals and healthcare facilities. Controlled substances are a necessary component of medical care for patients, and recent employee diversion incidents illustrate the continued vulnerability …
A memorable Florida Orange Growers’ television ad campaign in the late 1970s proclaimed that “Orange juice from Florida isn’t just for breakfast anymore.” The Federal Controlled Substances Act (“CSA”) and its regulations require Drug Enforcement Administration (“DEA”) registrants to submit certain reports related to narcotic …
Special Surveillance List of Chemicals, Products, Materials and Equipment Updated A “laboratory supply” is any List I or List II chemical, or any chemical, substance, or other item on a special surveillance list published by the Attorney General (delegated to the Drug Enforcement Administration (“DEA”)) of …
We appreciate receiving feedback on our blog posts. We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies “were invalid because they lacked a legitimate medical purpose or were not issued in the …
Last month the U.S. Attorney’s Office for the Northern District of Illinois announced that Walgreens agreed to pay up to $350,000,000 to resolve allegations that its pharmacies illegally filled millions of invalid prescriptions for opioids and other controlled substances in violation of the federal Controlled …
Drug Enforcement Administration (“DEA”) civil monetary settlements involving listed chemicals that do not include pseudoephedrine are rare. Even more scarce are DEA civil settlements with non-registrants. (By my count there have been only ten since 2000). When one comes along, it is worthwhile to sit …
We published a version of this post several years back (see here), but recent updates to the law and trends in DEA enforcement merit a refresher. The stakes are high when a DEA-registered practitioner, pharmacy, distributor, manufacturer, or other registrant receives an Order to Show …
With a nod to the immortal phrase, “Bring out your dead! Bring out your dead!” uttered by body collector Eric Idle, and to the Knights Who Say “Ni!,” from the 1975 comedy romp, Monty Python and the Holy Grail, in calling attention to Drug Enforcement …
Last month, we blogged on the Department of Justice’s (DOJ) abrupt announcement that it had determined that removal restrictions protecting administrative law judges (ALJs) were “unconstitutional” and that DOJ would no longer defend those removal restrictions in court. We opined that while the impact of …
In August 2023, the U.S. Department of Health and Human Services (“HHS”), based on the federal Controlled Substances Act’s (“CSA’s”) Eight Factor Analysis, recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I to schedule III. The U.S. Department of Justice subsequently conducted …
