The FDA Law Blog
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.
The FDA Law Blog
FEBRUARY 27, 2023
Palmer — The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. DEA’s proposed rule when finalized would authorize telemedicine pursuant to the Controlled Substances Act, 21 U.S.C. § By Karla L.
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The FDA Law Blog
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.
The FDA Law Blog
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. §
The FDA Law Blog
FEBRUARY 5, 2024
Some of the services HP&M offers include: comprehensive regulatory assessments pre-launch licensing support license gap analysis support for new product/company acquisitions, regulatory diligences DEA registrations and state-controlled substance licenses With the complexities of licensure, Sara M. Palmer , Larry K.
The FDA Law Blog
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. And, FDA still doesn’t. Attorney’s Offices around the country.
The FDA Law Blog
FEBRUARY 27, 2023
This error has appeared not just in articles and other news publications but in some court documents as well. In many cases, it appears DEA does not have the resources or infrastructure to maintain and produce the information to respond to FOIA requests as do other administrative agencies such as FDA.
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