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. 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.

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Controlled Substances Documentation Dosage Prescription Filling 139

FDA Law Blog: Biosimilars

MAY 19, 2025

While the presence of a dispensing red flag does not prohibit a pharmacist from filling a controlled substance, it means that there is a potential concern with the prescription, which the pharmacist must address andmake a record of its resolution, assuming it is resolvable.

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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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Controlled Substances Long-Term Care Facilities Dosage Communication 98

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.” Last December we blogged on the $275,000 civil penalty imposed by the U.S. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec.

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Controlled Substances Dosage Documentation 52

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. §

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FDA Law Blog: Biosimilars

JULY 1, 2024

The request for hearing follows a n October 2023 letter preceding the NPRM from six former Administrators and five former Directors of National Drug Policy. The C ontrolled S ubstances A ct (“CSA”) requires analysis of eight statutory factors for scheduling, rescheduling, or descheduling substances of abuse. 21 U.S.C. §

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The Happy PharmD

APRIL 26, 2023

I decided to calculate the dosage quickly. A 5ml dosage contains 1.8g Or maybe there might be a different dosage of what you (the resident) want. It was available at a dosage of 0.5mg/5 ml. Dexamethasone oral solution is not a narcotic or controlled substance. Writing the dosage as a percentage.

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Dosage Hospitals Pharmacy Technician Prescription Filling 52