On June 27, 2022, in one of the last opinions issued during its current term, a majority of the U.S. Supreme Court (six justices) issued a noteworthy opinion on criminal liability related to prescribers of controlled substances. This consolidated case has implications not only for …
On June 8, 2022, the U.S. Attorney’s Office for the Western District of Virginia, announced that Sovah Health (“Sovah”), a two-campus health system in Danville and Martinsville in southern Virginia, had entered into a non-prosecution agreement (“NPA”) and $4.36 million civil settlement due in large …
Last week, Attorney General Merrick Garland reiterated the position expressed during his confirmation hearing that enforcement of marijuana cases in states where activities are legal is an inefficient use of Department of Justice (“DOJ”) resources. Responding to Senator Brian Schatz (D-Hawaii) during a Senate Appropriations …
Effective May 11, 2022, the Drug Enforcement Administration (“DEA”) will require all applications and renewals for registration to be submitted electronically. DEA issued a final rule on April 11, 2022, eliminating the “mail-in” option, believing that initial and renewal applications submitted online will be more …
Effective April 1, 2022, California Board of Pharmacy (“BOP”) regulations no longer require reporting every single missing tablet or dosage form. Instead, the amended loss regulations establish thresholds which will reduce the number of reports received by the California BOP, and in our opinion, creates …
The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We blogged on the final 2016 guideline here on March 17, 2016). On February 10th, the agency published a comprehensive proposal …
The Drug Enforcement Administration (“DEA”) recently issued another Final Order revoking a pharmacy registration based on the failure of the pharmacy to meet its corresponding responsibility, more specifically, the failure to identify and resolve red flags. While the Final Order does not necessarily introduce any …
DEA is proposing to amend its regulations to expressly permit the transfer between pharmacies of an initial controlled substance prescription. Currently, DEA regulations do not address transfer of controlled substance prescriptions — whether paper or electronic — between pharmacies for the initial filling of the …
Last week the Drug Enforcement Administration (“DEA”) issued a direct final rule clarifying requirements about who may record the supplier’s DEA registration number on a single-sheet DEA Form 222 (“single-sheet form”). Clarification Regarding the Supplier’s DEA Registration Number on the Single-Sheet DEA Form 222, 86 …
The Drug Enforcement Administration (“DEA”) recently issued its final rule authorizing the use of mobile narcotic treatment programs (“MNTPs”) to allow registered Narcotic Treatment Programs (“NTPs”) employing mobile units to dispense medication for maintenance or detoxification treatment remotely. Registration Requirements for Narcotic Treatment Programs with …
A recent proposed amendment to Minnesota’s Opiate Product Registration Fee appears intended to ensure continued availability of certain opiate products at hospitals. On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services …
This is the third in a series of posts on what DEA registrants can expect during cyclic and on-site inspections. Our series focuses on the background of such inspections, how investigators conduct them and how registrants should proactively prepare for and manage them. Part 1, …
Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. We are providing a post in three parts on …
Observers can be forgiven for thinking that the Drug Enforcement Administration’s (“DEA’s) primary focus is suspicious controlled substance orders or pharmacists’ “corresponding responsibility.” While these areas have been the subject of increased enforcement activity because of the national opioid epidemic, DEA registrants should not forget …
Hyman, Phelps & McNamara, P.C. and Analysis Group are partnering to host a two-hour timely, informative and free program to discuss current important legal perspectives and analytical trends concerning the Controlled Substances Act and the Drug Enforcement Administration. The webinar is scheduled to take place …
