2021 Controlled Substances Dosage 
FDA Law Blog: Biosimilars
MAY 19, 2025
86, 72703 (December 22, 2021), DEA emphasized in the Gulf Med decision that prescribing [r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm. Attorneys Office, Northern District of Illinois, April 21, 2025.
FDA Law Blog: Biosimilars
DECEMBER 4, 2023
Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.
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FDA Law Blog: Biosimilars
JUNE 27, 2024
District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” As for high dosage opioid prescriptions, the expert found that: Patient A.R. Gulf Med Pharmacy; Decision and Order, 86 Fed.
FDA Law Blog: Biosimilars
AUGUST 8, 2024
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. §
Pharmaceutical Technology
APRIL 12, 2023
Containment and controlled substance capabilities are defining and necessary features for these manufacturing facilities, but not all contract manufacturers have the specialist equipment and capabilities required for high potency small molecule API production.
FDA Law Blog: Biosimilars
APRIL 8, 2024
Specifically, DEA establishes an aggregate production quota (APQ) for each class of controlled substance listed in schedule I and II, and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, which limits the amount of each substance that can be manufactured in a given year.
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