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DEA Reaffirms Synthetic THC Compounds Are Schedule I Controlled Substances

The FDA Law Blog

Houck — The Drug Enforcement Administration’s (“DEA’s”) February 13th determination that THC acetate ester (“THCO”) is a schedule I controlled substance under the federal Controlled Substances Act (“CSA”) has received a good amount of attention in the cannabis press. By Larry K. 51639, 51641 (Aug.

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Telemedicine and the Prescribing of Controlled Substances After the End of The Covid-19 Pandemic Emergency: DEA Announces Two Significant Proposed Rules: Read the Summary Below, But Learn All the Details and More at HPM’s Webinar on March 23, 2023 (Details Forthcoming….)

The FDA Law Blog

Palmer — The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. The Act also established new definitions for “Internet,” “online pharmacy,” “practice of telemedicine,” among others. By Karla L. 21 U.S.C. §

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Stop the Presses! DEA and DOJ Fine eBay for not Reporting Sales of Tableting and Pill Press Machines

The FDA Law Blog

Gilbert — 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. 21 U.S.C. §

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Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

The FDA Law Blog

Houck — 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 Larry K. 53,688 (Aug. 53,767 (Aug.

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A Long Strange Trip: Companion Bills Would Facilitate Psychedelics Research

The FDA Law Blog

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. By Larry K. 21 U.S.C. § 802(a) (7)(A)).

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FDA Takes Another Small Step to Increase Naloxone Access

The FDA Law Blog

In light of the urgent public health need to facilitate and expedite access to naloxone, FDA is implementing this Guidance immediately without prior public comment. Naloxone is a prescription drug, but unlike some other prescription drugs used in the treatment of opioid addiction such as buprenorphine , it is not a controlled substance.

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May 11, 2023: The End of the COVID-19 Pandemic Emergency’s DEA Telemedicine Exemption? “Not So Fast,” Say DEA and SAMHSA

The FDA Law Blog

Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. 802(54)(G) (which references CMS’s statutory definition of “practice of telemedicine”). By Karla L. 1307.41and 42 C.F.R. at 30,039 (emphasis added).