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

The FDA Law Blog

CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72 hours for emergency oral prescriptions).

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Competition is on the horizon for costly narcolepsy treatments

pharmaphorum

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.

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Retail Inventory Services Settle for Employee Thefts from Pharmacies

The FDA Law Blog

Attorney’s press release observes, it is a stark reminder that registrants are “ultimately responsible for supervising all personnel on the premises and preventing the diversion of controlled substances.” Company Pays $158,760 to Resolve Claims Related to Controlled Substance Thefts From Pharmacies During Inventory, U.S.

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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. §

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Pharmacies Selling PSE: Remember to Train Employees and Self-Certify

The FDA Law Blog

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 (“CSA”). We note that in December 2020, the same U.S.

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Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling

The FDA Law Blog

Houck — Administrator Anne Milgram has been on the receiving end of high-level support for and against rescheduling marijuana since the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended the Drug Enforcement Administration (“DEA”) reschedule from schedule I to schedule III last August. By Larry K.