STAT
OCTOBER 2, 2024
urged the DEA to continue allowing health providers to prescribe buprenorphine, a controlled substance used to treat opioid addiction, without requiring an in-person visit. Prior to the Covid-19 pandemic, any patient who needed a controlled substance was required to be examined in person before receiving a prescription.
FDA Law Blog: Biosimilars
JULY 31, 2023
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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FDA Law Blog: Biosimilars
AUGUST 21, 2023
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.
pharmaphorum
DECEMBER 14, 2022
In 2020, and in an attempt to abate the drawback, Jazz got FDA approval for Xywav, which is a mixture of calcium, magnesium, and potassium salts that contains 92% less sodium than Xyrem. Harmony Biosciences introduced Wakix to the market in 2019 as the first non-controlled substance for the treatment of narcolepsy.
FDA Law Blog: Biosimilars
APRIL 10, 2023
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. §
Pharma in Brief
JANUARY 7, 2024
Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen. Biologics, controlled substances, and certain other drugs are not eligible for importation. Prescription drugs, biologics, controlled substances, and certain other drugs (FDR section C.01.014.8).
FDA Law Blog: Biosimilars
APRIL 22, 2024
The Senators implore efforts to reschedule marijuana be driven by facts, “not the administration’s favored policy,” and question whether rescheduling would violate the Controlled Substances Act (“CSA”) and U.S. The Single Convention imposes more stringent controls on schedule IV substances than on schedule I substances.
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