Hospitals and healthcare systems simply must comply with all federal Controlled Substances Act (“CSA”), Drug Enforcement Administration (“DEA”) regulations, and state requirements. Controlled substances are critical to patient care but a myriad of required recordkeeping, reporting and security make hospitals and healthcare systems particularly vulnerable. …
President Donald Trump signed an Executive Order in December directing the Attorney General to expedite completion of marijuana rescheduling to facilitate medical research begun in October 2022. The President opined that federal officials were “slow-walking” marijuana rescheduling during the signing of an Executive Order expanding …
The Byrds was one of my favorite bands growing up. I find much of their music fresh and timely today due in no small part to Roger McGuinn’s trademark jingle-jangle on the Rickenbacker twelve-string guitar. The Byrds’ version of Pete Seeger’s “Turn! Turn! Turn!” reached …
The Drug Enforcement Administration (“DEA”) and the United States Attorney’s Office for the Eastern District of California just announced that Sutter Medical Center and Sutter Fairfield Surgery agreed to pay $3.2 million to resolve allegations that they failed to effectively guard against theft and diversion …
The Drug Enforcement Administration’s (“DEA’s”) final rule issued September 30, 2019, implemented the single sheet format for DEA Forms 222 (“DEA-222s”) and allowed a two-year transition from the triplicate form to the single sheet. New Single-Sheet Format for U.S. Official Order Form for Schedule I …
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 …
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. …
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 …
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. …
