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These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. We will discuss the state of relevant laws prior to our new “COVID reality” and telemedicine issues during and post-pandemic, both with respect to the prescribing of controlledsubstances and non-controlled drugs.
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 ControlledSubstances Act (“CSA”) to schedule III. Hyman, Phelps & McNamara, P.C.
Palmer — The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlledsubstances. DEA’s proposed rule when finalized would authorize telemedicine pursuant to the ControlledSubstances Act, 21 U.S.C. § By Karla L.
Accounting for controlledsubstances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection. The webinar will share additional valuable inspection tips. Hyman, Phelps & McNamara, P.C. (“HP&M”)
Accounting for controlledsubstances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection. Registrants are far from powerless when DEA investigators inspect their controlledsubstance operations.
Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlledsubstances, 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 proposed rules for prescribing controlledsubstances generally, and for buprenorphine use in opioid treatment. HPM also conducted a 90-minute webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.”
Thank you to those who registered for and attended Hyman, Phelps & McNamara’s March 23, 2023 lunchtime webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.” As promised during the 90-minute program, we provide our slides here, and a recording of the program, here (passcode.
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 controlledsubstance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.
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 controlledsubstance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.
Director Larry Houck will present a webinar on HHS’ cannabis rescheduling recommendation hosted by the National Association of State ControlledSubstance Authorities (“NASCSA”) scheduled for Tuesday, January 9, 2024 at 3:00 pm (Eastern). Hyman, Phelps & McNamara, P.C.,
UMSOP and the FDA, through COMmunity Mistrust and Institutional Trustworthiness to Advance Health EQuity Research (COMMIT-EQ), seek to better understand this challenge and ameliorate it for future COVID-19 vaccine development to better ensure vaccines are safe and effective for all communities. Register today!
1,2 New products are entering the market that could be poised to revolutionize the inventory counting process for pharmacists and health care providers, especially for controlledsubstances.
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