The Drug Enforcement Administration (“DEA”) has received more than 27,000 public comments in response to its May 21, 2024, Notice of Proposed Rulemaking (“NPRM”) to reschedule marijuana from schedule I to schedule III. However, none may carry more weight than a short comment just over …
We blogged in February 2022 about the Drug Enforcement Administration’s (“DEA’s”) revocation of Gulf Med Pharmacy’s registration after finding that it failed to exercise its corresponding responsibility by repeatedly filling controlled substance prescriptions that exhibited “obvious red flags of diversion without documenting the resolution of …
For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. The CSA and regulations promulgated by DEA are …
Last month the Department of Justice and the Drug Enforcement Administration submitted a notice of proposed rulemaking to reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Hyman, Phelps & McNamara, P.C. Director Larry Houck will participate as a …
It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. We learned this week that Palomar Health, one of California’s largest healthcare districts, agreed to pay $250,000 to resolve allegations that numerous …
Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). But there has been a recent string of large civil monetary settlements, some in the millions of dollars, …
The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. US poised to ease restrictions on marijuana in historic shift, …
On April 23, 2024 we blogged about Republican Senators Mitt Romney, Pete Ricketts and James Risch advising Drug Enforcement Administration (“DEA”) Administrator Anne Milgram to consider U.S. treaty obligations under the Single Convention, 1961, when rescheduling marijuana. Later Democratic lawmakers, eleven senators and ten members …
Administrator Anne Milgram has been on the receiving end of high-level support for and against rescheduling marijuana since the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended the Drug Enforcement Administration (“DEA”) reschedule from schedule I to schedule III last August. …
Medicine cabinet, stuffed to the gills Capsules, liquid, patches, and pills Expired oxy, hydro, benzos, and more All kind of old meds flowing out the door We will, we will, clear you We will, we will, clear you Back by popular demand, coming to a collection site in your town for …
With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985, we present “Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not.”* The wide range of assertions supporting or opposing Health and Human Services’ (“HHS’”) …
Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. As stated in …
HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. With regulations varying significantly from one state to another, companies in these sectors …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. The conference is billed as the premier event to provide folks with a …
In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By doing so, FDA determined that marijuana not …
