Controlled Substances Documentation Information 
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
FEBRUARY 7, 2024
Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. 21 U.S.C. §
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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.” Coconut Grove Pharmacy; Decision and Order, 89 Fed. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec. 50,372 at 50,372-73.
FDA Law Blog: Biosimilars
MARCH 9, 2023
We might conduct numerous interviews, look at thousands of documents, and travel to whatever locations are necessary. We prepare a report that we share with our client and make a recommendation to our client about whether to disclose the information to FDA. Attorney’s Offices around the country.
Pharmaceutical Technology
SEPTEMBER 23, 2022
And, because it also manufactures products, its staff is current on regulatory requirements and FDA/ICH Guidance documents. Since CDMOs have different material handling capabilities, when choosing a partner, it’s important to understand if the drug will involve a controlled substance, hormone, small molecule or biological.
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