2025 Controlled Substances FDA 
pharmaphorum
DECEMBER 14, 2022
Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.
The FDA Law Blog
DECEMBER 12, 2024
The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III. Last weeks prehearing conference set the parameters for the hearing on the merits, scheduled to begin January 21, 2025. Prehearing Ruling (Dec. 4, 2024), at 1.
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The FDA Law Blog
FEBRUARY 11, 2025
Houck One of the most significant issues facing hospitals and other facilities is the diversion of controlled substances meant for patients by physicians, pharmacists, nurses and other trusted healthcare employees.
The FDA Law Blog
FEBRUARY 18, 2025
23, 2025), DEA reviewed evidence from an administrative hearing and upheld the Administrative Law Judges (ALJs) recommended decision to revoke the registration of a pharmacy that DEA alleged dispensed controlled substances to patients without resolving numerous red flags of diversion. In Neumanns Pharmacy, LLC , 90 Fed.
The FDA Law Blog
NOVEMBER 21, 2024
temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. use of buprenorphine) for opioid use disorder, and for Schedule III-V non-narcotic controlled substances unless the patient receives an in-person examination.
The FDA Law Blog
MARCH 6, 2025
This statement followed a February 20, 2025 letter from Acting Solicitor General Sarah Harris to President Pro Tempore of the Senate Charles Grassley stating the same and noting that the Department will no longer defend the layers of removal restrictions for ALJs in court. Bondi , No. 3:23-cv-2883-E, ECF No.
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