We follow the civil settlements agreed to by the Drug Enforcement Administration (“DEA”) and registrants that are announced in press releases by U.S. Attorney’s Offices and DEA. We were interested to observe what appeared to be a recurring theme running through four of the six …
President Donald Trump signed an Executive Order on Thursday last week directing the Attorney General to expedite completion of marijuana rescheduling begun in October 2022 to facilitate medical research. There was uncertainty whether President Trump, now in the White House, would support rescheduling. Candidate Trump …
With a nod to the immortal phrase, “Bring out your dead! Bring out your dead!” uttered by body collector Eric Idle from the 1975 comedy romp, Monty Python and the Holy Grail, in calling attention to Drug Enforcement Administration’s 29th National Prescription Drug Take Back …
I became a Diversion Investigator with the Drug Enforcement Administration (“DEA”) in 1986, but it only recently dawned on me that my relationship with the agency actually began as a ninth grader about 14 years earlier. In 1972, DEA’s predecessor, the Bureau of Narcotics and …
The legal and regulatory landscape for controlled substances is in flux – telehealth prescribing rules have been extended to December 31, 2025, the new “HALT Fentanyl Act” heads to President Trump’s desk, all while recent opioid settlements signal sharper enforcement. Against this backdrop, the American …
In a case involving international horse-doping conspiracies, racetracks, and state horse racing regulators, the Second Circuit expanded the application of the FDC Act’s felony provisions. There are two forms of criminal penalties for violations of the FDC Act contained in 21 U.S.C. § 333(a): a strict …
The California Board of Pharmacy (the “Board”) implemented a novel approach to address employee theft as one aspect of the opioid epidemic in 2018 by requiring pharmacies and clinics to reconcile their quarterly schedule II inventories. The approach was novel because to our knowledge, no …
Drug Enforcement Administration (“DEA”) diversion investigators conduct random, unannounced cyclic inspections of “non-practitioner” registrants (manufacturers, distributors, importers, exporters and narcotic treatment programs) about every three years. Investigators also randomly inspect hospitals, pharmacies and practitioners. With civil monetary penalties for violations of recordkeeping and reporting requirements …
On the heels of President Donald Trump saying that he is considering executive action on marijuana rescheduling determination, Representative Greg Steube (R-Florida) reintroduced his Marijuana 1-to-3 Act that would legislatively reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. …
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 …
