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 …
In October 2022 President Joseph Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General to begin the administrative process of reviewing expeditiously how cannabis is scheduled under federal law. HHS recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from …
Last week, in a letter thanking President Joe Biden for his leadership to federally reschedule cannabis, Democratic governors sought to make the case for rescheduling. Letter to President Joseph R. Biden, Jr., from Governor Jared Polis et al., Dec. 5, 2023. The governors (of Colorado, Illinois, …
Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. District Court for the Western …
The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals. Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture …
Medicine cabinet, stuffed to the gills Capsules, liquid, patches, and pills Expired oxy, hydro, benzos, and more All kind of meds flowing out the door We will, we will, clear you We will, we will, clear you Were the Drug Enforcement Administration (“DEA”) a rock band, it might promote the upcoming …
On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. As a reminder, back in February 2023, HPM blogged about DEA’s two …
More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted …
More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted …
Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; and • Lack of accepted safety for use under medical supervision. 21 U.S.C. § 812(b)(1). Schedule III: • Potential for abuse less than drugs or …
Last week the U.S. Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act …
If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. However, electronic prescriptions for controlled substances (“EPCS”), which a practitioner transmits directly to a pharmacy, do …
