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

FDA Law Blog: Biosimilars

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.

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Revolutionizing Health Care: The Evolving Path of E-Prescriptions

National Association of Boards of Pharmacy

provided prescribers with the option to use e-prescriptions for controlled substances (CS) based on an interim final rule published in 2010. This blog was adapted from an article that originally appeared in the January 2024 issue of Innovations. Aiming to prevent these errors, Drug Enforcement Administration.

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Not Content to Just Play the Hits, DOJ’s New Corporate Enforcement Policies Bring A Fresh Spin to Corporate Enforcement

FDA Law Blog: Biosimilars

He wrote about the lack of any assurance that FDA would appropriately credit disclosure in a 1999 FDLI article. Our colleague John Fleder has long advocated for a voluntary disclosure program at FDA. Many federal agencies do have policies that provide a safe harbor for voluntary disclosures, but FDA does not. And, FDA still doesn’t.

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Lifelong Learning in the Role of a Pharmacy Inspector 

National Association of Boards of Pharmacy

During multiple pharmacy investigations, I discovered that pharmacists were diverting controlled substances for their personal use. This blog was adapted from an article that originally appeared in the May 2023 issue of Innovations. Is there an inspection experience that you found particularly interesting, egregious, or unusual?

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Xylazine and Opioid Overdoses Spur Government Action

National Association of Boards of Pharmacy

Furthermore, xylazine is also associated with physical dependence, withdrawal symptoms, and a general substance use disorder (SUD). While federal law does not classify the drug as a controlled substance (CS), some states have enacted laws or temporary orders to regulate its possession, distribution, and use.

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Tactics Criminals Use to Sell Drugs Online  

National Association of Boards of Pharmacy

The United States is home to one of the most secure drug supply chains in the world, but criminals still find pathways to buy and sell prescription drugs—including controlled substances—often using websites and social media platforms to do so.

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Building Intelligent Pharma Supply Chain Management with Real-World Data

Pharmaceutical Commerce

This is particularly important for sensitive medications such as controlled substances, which can be at a higher risk for counterfeiting and diversion. Centers for Disease Control and Prevention’s National Center for Health Statistics. References 1. FDA at a Glance. Therapeutic Drug Use.