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A Long Time Coming: DEA Regs Finally Authorize Schedule II Prescription Partial Fills

FDA Law Blog: Biosimilars

Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. By Larry K. 78,282 (Dec.

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Federal Marijuana Rescheduling: States Get Ready

FDA Law Blog: Biosimilars

Comments ranged from single sentence declarations to lengthy, cogent treatises, expounding on whether to reschedule marijuana from schedule I to schedule III or another schedule under the federal Controlled Substances Act (“CSA”), to leave marijuana in schedule I, or to deschedule altogether. 21 U.S.C. § 812(c)(c)(10). 21 U.S.C. §

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Joint Basis for FDA/HHS Marijuana Rescheduling Recommendation Unveiled

FDA Law Blog: Biosimilars

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. 53,688 (Aug. 53,767 (Aug. 21 U.S.C. §

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Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016). 53,688 (Aug. 53,767 (Aug. 21 U.S.C. §

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DEA Concurs: Marijuana Meets Schedule III Criteria

FDA Law Blog: Biosimilars

Houck — 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. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.