On October 28th, DEA issued the guidance we anticipated and discussed over two years ago in our June 2024 blog post. The guidance explains when a DEA-registered pharmacy may deliver a prescribed controlled substance directly to a practitioner for administration to a patient, so long …
Folks often confuse soundalike terms “biennial” and “biannual” with one another. “Biennial” refers to every two years while “biannual” means twice a year. Drug Enforcement Administration (“DEA”) regulations require registrants after taking an initial inventory of all controlled substances on-hand to take a “biennial” inventory …
The Controlled Substances Act (“CSA”) and Drug Enforcement Administration (“DEA”) regulations mandate legitimate handlers of controlled substances to obtain a DEA registration, create and maintain certain controlled substance records and reports, and implement effective security to guard against diversion. The underlying purpose of those requirements …
Hyman, Phelps & McNamara, P.C.’s Karla Palmer and Andrew Hull will be speaking again at IQVIA’s 28th Annual Controlled Substance & State Regulatory Conference in Scottsdale, AZ (Sept. 16-18). As part of a stacked agenda that runs the gamut on controlled substances issues, Ms. Palmer will …
Former late night comedy institution David Letterman introduced his long-running, ever popular, Top Ten List* on Late Night with David Letterman on September 18, 1985. Drug Enforcement Administration (“DEA”) registrants, primarily hospitals/healthcare systems and pharmacies, have resolved alleged recordkeeping, reporting and security violations of the …
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. …
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 …
