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

FDA Law Blog

The government asserted additional allegations that are outside our scope. Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Zarzamora Press Release.

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Risking It All For a New Business Model at Family Physicians of St. Joe

Family Physicians of St. Joseph

In 2007, Dr. Mancini joined the practice, followed by Dr. Meadows in 2012, and Dr. Gendernalik in 2015. And, they host local medical students at the office, teaching them not only medicine, but what it means to truly care for patients, hopefully inspiring a new generation of students to pursue careers locally in primary care.

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Prescribing Red Flags: Pharmacists Be Wary of What the Doctor Orders

FDA Law Blog

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. Attorneys Office, Northern District of Illinois, April 21, 2025. Complaint, 82. 81, 86, 251.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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Agitation Podcast Series Episode 2: Non-pharmacologic management of agitated children

PEMBlog

Government. For more information, please visit HRSA.gov To learn more about the Emergency Medical Services for Children Innovation and Improvement Center visit [link] Email km@emscimprovement.center Follow on Twitter @EMSCImprovement References Berzlanovich AM, Schöpfer J, Keil W. 2012 Jan;109(3):27-32. 2012 Feb;13(1):35-40.

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. In psychiatry, a lot of the anti-epileptic medications, we call them mood stabilizers and are used in bipolar disorder. Eric: Are these generic? Nisha: Both of them are generic, yeah.

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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.