Hyman, Phelps & McNamara, P.C. (“HPM”) Director Larry Houck will moderate “New Rules, New Risks: Inside the Changing World of Federal Inspections” at the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference in Washington, D.C., December 4-5, 2025. The session will explore the …
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 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. …
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 …
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 …
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 …
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 …
