Controlled substances are critical to patient care, but hospitals have always been vulnerable to their diversion by trusted employees. In a number of recent cases, employees have been able to divert considerable quantities of controlled substances undetected over extended periods of time. These incidents resulted …
This is the second in our series analyzing the riders attached to the FY 2026 Labor-HHS Appropriations Bill. This installment examines the drug-related provisions, which cover a wide range of topics from accelerated approval and rare disease therapies to biosimilars and opioid regulation. The Committee’s …
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 …
It’s been a month since DOJ announced the “first-ever Department-wide corporate enforcement policy” for criminal matters. Touted as a means of “promoting uniformity, predictability, and fairness” in how DOJ pursues white-collar cases against corporate defendants, the new “Corporate Enforcement and Voluntary Self-Disclosure Policy” (CEP) sets …
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 …
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 …
