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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Controlled Substances FDA Documentation Communication 59

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. §

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Controlled Substances Documentation 116

OctariusRx

SEPTEMBER 12, 2022

Some of the topics to be discussed include regulatory requirements/standards, the most often cited standards, safe injection practices, medication reconciliation, confused drug names, high-alert medications, controlled substance management, how to mitigate controlled substance diversions, documentation and much more.

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Controlled Substances Documentation 80

OctariusRx

FEBRUARY 6, 2023

The topic of properly handling controlled substances is always at the forefront of any discussion on compliance, but it extends far beyond just a paper trail. Having a compliant policy and good documentation is only the beginning of regulatory compliance, mitigating risks for patients and liability for facilities.

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Controlled Substances Documentation Hospitals Patient Care 72

The FDA Law Blog

JUNE 27, 2024

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.” Coconut Grove Pharmacy; Decision and Order, 89 Fed. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec. 50,372 at 50,372-73.

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Controlled Substances Documentation Insurance Dosage 52

The FDA Law Blog

DECEMBER 12, 2024

The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III. The DEA Administrator issued a General Notice of Hearing fixing December 2nd as the commencement date for the hearing. Cross-examination will be limited to twenty minutes for each party on the opposing side.

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Controlled Substances Documentation 52

Omnicell

JANUARY 10, 2023

Yet in operating rooms and procedure areas – where a large quantity of tightly regulated controlled substances are administered – similar technology is used by just over half of health systems. Ideally pharmacy and anesthesia providers should work in partnership to maintain controlled substance accountability.

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Controlled Substances Omnicell Medication Dispensing Documentation 52

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.

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Controlled Substances Documentation Communication 45

DiversifyRx

OCTOBER 27, 2023

Understanding DEA Compliance DEA, the agency responsible for regulating controlled substances, is stepping up actions with independent pharmacies. The control and distribution of controlled drugs have always been highly regulated. Without proper documentation, it’s as if the conversation never happened.

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Independent Pharmacies Controlled Substances Documentation Communication 40

Board Vitals - Pharmacist

JANUARY 6, 2023

Upon first renewal, requirements include one hour in HIV/AIDS, professional and medical ethics, Florida laws and rules, and controlled substances, as well as, two hours of domestic violence and medical errors prevention. Physicians who prescribe controlled substances must earn 3 hours per CME cycle on controlled substance prescribing.

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Controlled Substances Documentation 59

Omnicell

JANUARY 10, 2023

A manual medication workflow can lead to possible safety gaps, especially in an OR where there's no guarantee that every controlled substance will be at your disposal in an organized fashion should something go wrong and when the unexpected arises during surgeries and procedures. It becomes a genuinely tedious and risky practice.

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Controlled Substances Omnicell Medication Dispensing Documentation 52

Omnicell

JANUARY 10, 2023

At TidalHealth, we're partnering with our nursing and anesthesia colleagues to drive diversion awareness and controlled substance monitoring. The Chief of Anesthesia is now aware of flaws in documentation and has an awareness of open transactions through enhanced data visibility.

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Omnicell Medication Dispensing CPhT Documentation 52

indispensable health

JANUARY 12, 2021

Do your pharmacy service provide guided assistance obtaining a DEA License and a Controlled Substance (CS) License for my Ambulatory Surgery Center? Can your pharmacy services support our ASC with the medication-related forms, policies & procedures, as well as, other pharmacy documentation? FREE ASC Pharmacy Checklist.

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Controlled Substances Documentation 52

The Checkup by Singlecare

JULY 20, 2024

It is a Schedule IV controlled substance and is sold under the brand names Adipex-P and Lomaira. Still, “its effects on ADHD symptoms are not well-documented,” he stresses. Phentermine is a central nervous system (CNS) stimulant approved by the U.S. Food and Drug Administration ( FDA ) as a weight loss medication.

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Adverse Reactions FDA Controlled Substances Documentation 90

Omnicell

SEPTEMBER 5, 2022

.” This CE-accredited session for pharmacy and nursing discussed how COVID-19 is compounding complications of Substance Use Disorder, and shared best practices for diversion monitoring in order to refocus resources and revise schedules amidst COVID-19.

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Omnicell Controlled Substances Hospitals Documentation 52

Omnicell

SEPTEMBER 5, 2022

There are additional complications that arise from hyper-vigilante manual processes that can sometimes result in false positives and uncomfortable staff conversations due to documentation errors.

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Controlled Substances Hospitals Documentation 52

The Checkup by Singlecare

JANUARY 2, 2025

Its important to note also that Klonopin is a schedule IV controlled substance due to its potential for misuse and addiction. Clonidine is not classified as a controlled substance because it has no known risk of abuse. Its a schedule IV controlled substance thats approved by the U.S.

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Controlled Substances Dosage Insurance Labelling 52

indispensable health

JANUARY 11, 2022

As a pharmacist I am a reference for drug related questions and I encourage safe medication practices.

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Drug Storage Controlled Substances Documentation Compounding Pharmacies 52

Omnicell

JANUARY 10, 2023

For example, automating controlled substance administration protects nurses and patients alike. A closed-loop accountability system can help ensure solid procedures with ample documentation that assists the nurse.

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Omnicell Medication Delivery Hospitals Controlled Substances 52

The FDA Law Blog

MARCH 9, 2023

We might conduct numerous interviews, look at thousands of documents, and travel to whatever locations are necessary. They call us and ask us what to do. We tell them that they need a thorough investigation into the misconduct and if there is other wrongdoing. Attorney’s Offices around the country.

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FDA Controlled Substances Documentation 52

indispensable health

DECEMBER 8, 2020

The more in-depth services can include anything such as providing guidance on how to obtain DEA and Controlled Substance (CS) licenses, how to obtain a premix that has a 24-hour shelf-life, providing mid-construction audits so the ASC could be assured they were on the right path to meet their targeted opening day, and more.

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Pharmacy Service Companies Controlled Substances Customer Service Documentation 52

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. Gilbert — One misnomer that has been repeated over the years has been the reference to the “Drug Enforcement Administration” (“DEA”) as the “Drug Enforcement Agency.” The DEA has even made the same mistake.

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Documentation Controlled Substances FDA 45

The Checkup by Singlecare

NOVEMBER 30, 2023

Documentation, including birth certificates or social security numbers, is usually required to prove eligibility. You will need a prescription for anything that’s not over-the-counter (OTC), and some controlled substances require additional authorization from your provider before they will be covered.

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Nursing Homes Insurance Insurance Coverage Documentation 52

Pharmaceutical Technology

SEPTEMBER 23, 2022

And, because it also manufactures products, its staff is current on regulatory requirements and FDA/ICH Guidance documents. Since CDMOs have different material handling capabilities, when choosing a partner, it’s important to understand if the drug will involve a controlled substance, hormone, small molecule or biological.

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Packaging Controlled Substances FDA Documentation 59

The Checkup by Singlecare

FEBRUARY 1, 2024

Benzodiazepines are also a class of controlled substances that are abused or misused at times, and addiction is a possibility. There are many other interactions documented with oxycodone. Combining oxycodone and benzodiazepines should be done with extreme caution and under the direct supervision of a healthcare provider.

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Controlled Substances Documentation Labelling 52

OctariusRx

FEBRUARY 24, 2025

The 2025 controlled substance assessment quiz is about to be released! This is our annual competency assessment focused on controlled substances and regulatory compliance. The quiz focuses on some of the basic elements managing controlled substances. How are you assessing your staff?

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Controlled Substances Documentation 74

OctariusRx

DECEMBER 9, 2024

Do you store and administer controlled substances at your facility? Have you audited your controlled substance processes to ensure full compliance with state and DEA requirements? Can you provide a list of all employees who have access to controlled substances? Do you have a copy of your facility floor plan?

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Controlled Substances Documentation 86

OctariusRx

FEBRUARY 10, 2025

Having your documents properly stored and labeled will help with a smooth visit and full compliance with federal controlled substance requirements. In this weeks client newsletter, we discuss what to expect from a DEA inspection, as well as provide guidance on documents to have ready and discuss the risks of non-compliance.

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Controlled Substances Documentation Labelling 63

The FDA Law Blog

FEBRUARY 18, 2025

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.

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Controlled Substances Documentation 69

DiversifyRx

MARCH 17, 2025

Follow specific procedures for controlled substances and refrigerated items (many wont allow refrigerated returns on Thursdays or Fridays). Pro Tip: Keep these transactions well-documented for compliance and accuracy. Key Points: Bottles must be unopened, clean, and undamaged.

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Inventory Audits Controlled Substances Documentation 52