Remove Blog Remove Controlled Substances Remove Documentation
article thumbnail

What To Do When You Receive a DEA Order to Show Cause

The FDA Law Blog

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?

article thumbnail

DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag Resolution

The FDA Law Blog

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

The FDA Law Blog

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.

article thumbnail

Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be Filled

The FDA Law Blog

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.

article thumbnail

Omnicell and Fresenius Kabi Join Forces to Improve Controlled Substance Management

Omnicell

Tara Plappert Product Marketing Manager Hospitals and clinics face a significant challenge when dealing with controlled substances. The Controlled Substance Dispenser dispenses one dose at a time, ensuring security, and minimizing the need for nurse countbacks. And according to the 2019 Drug Diversion Digest , 47.2

article thumbnail

Telemedicine and the Prescribing of Controlled Substances After the End of The Covid-19 Pandemic Emergency: DEA Announces Two Significant Proposed Rules: Read the Summary Below, But Learn All the Details and More at HPM’s Webinar on March 23, 2023 (Details Forthcoming….)

The FDA Law Blog

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.

article thumbnail

Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

The FDA Law Blog

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.