Blog Controlled Substances Documentation 
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.
epicur
NOVEMBER 10, 2022
The following blog is written by Epicur Pharma’s Advisory Council member Jan Woods, a veterinary hospital consultant, and national speaker with expertise in DEA compliance, state and federal regulations, and clinic and hospital practice management. Have you ever broken or spilled a bottle of a controlled substance?
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FDA Law Blog: Biosimilars
AUGUST 9, 2023
Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. By Larry K.
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.” By Larry K. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). Gulf Med Pharmacy; Decision and Order, 86 Fed.
FDA Law Blog: Biosimilars
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.
FDA Law Blog: Biosimilars
APRIL 22, 2025
An Immediate Suspension Order is served along with an Order to Show Cause, allowing you to challenge DEAs determination that your registration should be revoked, but it takes away your ability to handle controlled substances while your case is pending. What Resources Are Available?
FDA Law Blog: Biosimilars
DECEMBER 12, 2024
The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III. The DEA Administrator issued a General Notice of Hearing fixing December 2nd as the commencement date for the hearing. Cross-examination will be limited to twenty minutes for each party on the opposing side.
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