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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

Larger companies now dominate the healthcare landscape, yet through innovation and a dedication to exceptional patient care, Family Physicians of St. They have remained independent and committed to caring for patients as a small practice, all the while introducing new ideas and setting new standards in Michigan’s Great Southwest.

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

FDA Law Blog

86, 72703 (December 22, 2021), DEA emphasized in the Gulf Med decision that prescribing [r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm. 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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. It’s not a controlled substance medication. Tasce: Yes. Taylor Swift.

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

PEMBlog

Patient that are agitated should always be treated with dignity and respect. Government. 2012 Jan;109(3):27-32. Structured team approach to the agitated patient in the emergency department. 2012 Feb;13(1):35-40. Deaths due to physical restraint. Dtsch Arztebl Int. Emerg Med Australas. 2009 Jun;21(3):196-202.

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Identifying and Resolving Red Flags: DEA Continues to “Run it Up the Flagpole”

FDA Law Blog

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” 12, 2012) (quoting Bob’s Pharmacy & Diabetic Supplies; Revocation of Registration, 74 Fed.

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