One year ago, we blogged on a DEA decision revoking the registration of a Louisiana pharmacy, Neumann’s Pharmacy, LLC, based on the pharmacy’s purported violation of its “corresponding responsibility” (21 C.F.R. § 1306.04(a)) and filling of prescriptions without resolving so-called “red flags” of diversion. The …
The Drug Enforcement Administration (“DEA”) has welcomed a new category of registrant: emergency medical services (“EMS”) agencies. DEA has finalized its regulations to conform with the Protecting Patient Access to Emergency Medications Act of 2017 (“the Act”), establishing a new registrant category, registration standards and …
Controlled substances are necessary for the medical care of patients, but recent diversion by pharmacists, physicians, nurses and other healthcare professionals illustrates the vulnerability of hospitals. Hospitals that fail to provide effective controls and procedures to guard against theft and diversion of controlled substances pose …
The American Conference Institute’s (“ACI”) FDA Boot Camp returns March 25-26, 2026, at the New York City Bar, New York, NY. This foundational training brings together life sciences attorneys, in-house counsel, and compliance professionals to dissect FDA law, policy, and enforcement trends. What You’ll Gain: A clear …
President Donald Trump’s Executive Order directed the Attorney General last month to expedite the completion of marijuana rescheduling, but also mandated that the Administration work with Congress to update the statutory definition of final hemp-derived cannabidiol (“CBD”) products for medical use of full spectrum CBD. …
DEA’s Former Chief Administrative Law Judge John J. Mulrooney, II (Partner, Belanger, Rae & Mulrooney, PLLC) and HPM’s Andrew Hull will be presenting at the American Conference Institute’s 7th Annual Summit on Controlled Substances taking place in New York City on January 26 & 27. …
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 …
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 …
