The FDA Law Blog

MARCH 12, 2023

We will discuss the state of relevant laws prior to our new “COVID reality” and telemedicine issues during and post-pandemic, both with respect to the prescribing of controlled substances and non-controlled drugs. John will present on considerations and his learned perspective for the future of teleprescribing.

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Controlled Substances FDA 98

The FDA Law Blog

OCTOBER 8, 2023

Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. HPM’s Presentation Deck and recording of the presentation are here, and here (passcode Bv3*o^i5).

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Controlled Substances 64

The FDA Law Blog

FEBRUARY 19, 2023

Hyman, Phelps & McNamara (“HPM”) Director Larry Houck will present “Prescribing Red Flags, Corresponding Responsibility and DEA Investigations: What’s a Pharmacist To Do?” at this year’s American Pharmacists Association’s (“APhA’s”) Annual Meeting in Phoenix, March 24-27. The session will occur Friday, March 24th.

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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.” Last December we blogged on the $275,000 civil penalty imposed by the U.S. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec.

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Controlled Substances Documentation Insurance Dosage 52

European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. The draft guidance is intended to advise researchers on aspects such as clinical study design as they develop medications that contain psychedelics.

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The FDA Law Blog

MAY 7, 2023

As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing controlled substances generally, and for buprenorphine use in opioid treatment. HPM’s Presentation Deck and Recording of the Presentation. slides are here, and here (passcode Bv3*o^i5).

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Controlled Substances 52

The Checkup by Singlecare

MARCH 22, 2023

Prescription drugs that may be restricted include controlled substances and medications that haven’t been approved for use in the U.S. Controlled substances If you are leaving or entering the United States with a controlled substance, the medication must be in the original, dispensed container and you must declare the drugs to a U.S.

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Health and Personal Care Stores Controlled Substances Dosage FDA 105

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. Judge Mulrooneys prehearing ruling establishes the schedule for the parties presentations and established hearing guidelines. Parties will have ninety minutes to present the testimony of their witness.

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The FDA Law Blog

MARCH 27, 2023

As promised during the 90-minute program, we provide our slides here, and a recording of the program, here (passcode. Our attorneys are happy to respond to questions you may have, and look forward to hearing from you.

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Controlled Substances 40

Pharmaceutical Technology

DECEMBER 5, 2022

However, at the federal level, cannabinoids remain illegal under the Controlled Substances Act. In Asia, Africa and the Middle East, cannabinoid-based drugs are mostly illegal and continue to present a major regulatory obstacle. However, access is restricted, requiring a special permit given under exceptional circumstances.

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The FDA Law Blog

JANUARY 11, 2024

HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C.

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Controlled Substances 59

The FDA Law Blog

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. By Larry K. 21 U.S.C. §

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Controlled Substances FDA 59

Med Ed 101

MAY 10, 2017

When giving a presentation the other day, I received a question about how to handle gabapentin abuse. It is a tough question, much like opioid, benzo, stimulant, or any other controlled substance. The post How to Handle Gabapentin Abuse appeared first on Med Ed 101.

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Controlled Substances 40

DiversifyRx

AUGUST 25, 2023

Ensure you are with C2 Keep’s innovative controlled drug recordkeeping solution. Are you 100% sure you are performing all requirements to maintain compliance with the Controlled Substance Act (CSA)? Unfortunately, your staff is the #1 most likely culprit for theft or diversion of controlled drugs.

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Independent Pharmacies Controlled Substances Patient Care 40

The Checkup by Singlecare

DECEMBER 13, 2024

Its not a controlled substance. These medications, which include Xanax ( alprazolam ), Ativan ( lorazepam ), and Klonopin ( clonazepam ), are controlled substances for a reason. You should take it situationally, such as before giving a big presentation or flying, about 60 to 90 minutes before the stressful event.

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Controlled Substances Labelling Dosage FDA 81

Board Vitals - Pharmacist

SEPTEMBER 3, 2022

As of November 2022, NPs have the authority to prescribe medications, including controlled substances, medical devices, and services, medical equipment and supplies in 26 states. You may submit the educational presentation or conference agenda as evidence to validate the contact hour calculation.

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Controlled Substances 52

The Checkup by Singlecare

MAY 2, 2024

Further, some adults with ADHD may also deal with substance abuse, in which the two conditions can intersect. Adderall is a controlled substance prescription stimulant that combines amphetamine and dextroamphetamine, two central nervous system (CNS) stimulants. But what is Adderall, exactly, and how does it work?

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Controlled Substances FDA 105

SingleCare

JANUARY 22, 2021

Controlled substances, for example, have special mailing requirements because of the Controlled Substances Act ( CSA ), which regulates the manufacturing, importation, and distribution of Schedule I, II, III, IV, and V drugs. Additionally, specialty medications can also be mailed,” he explains.

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Omnicell

SEPTEMBER 5, 2022

During our Omnicell Illuminate 2020 presentation “Streamlining Use of Technology at the Point of Care,” Nish Parekh, Vice President of Point of Care Solutions at Omnicell, and I explored how cloud-based solutions are getting us closer to the goal of zero-error medication management. One word: cloud.

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The Checkup by Singlecare

JULY 3, 2024

Unlike some other pain medications, ibuprofen is not considered habit-forming and is not classified as a controlled substance by the Drug Enforcement Administration (DEA). While uncommon, published case reports suggest the potential for misuse of ibuprofen in individuals with pre-existing substance use disorders.

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The FDA Law Blog

AUGUST 16, 2023

And before CooperSurgical, another 2021 Warning Letter was issued to AcelRx for the infamous “Tongue and Done” tagline used to promote a Schedule II controlled substance subject to a REMS program that requires a healthcare professional’s precise placement of the drug using a single-dose applicator into the patient’s sublingual space.

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FDA Labelling Controlled Substances Communication 52

Omnicell

SEPTEMBER 5, 2022

We have more than 50 industry experts leading health systems, including from Vanderbilt University Medical Center, Texas Children’s Hospital, Stanford, UCSF, TidalHealth, and Massachusetts General, just to name a few, addressing topics from controlled substance management to IV compounding , and more.

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Omnicell Controlled Substances Compounding Hospitals 52

Omnicell

SEPTEMBER 5, 2022

Navy, taught us the power of overcoming our fears and having the courage to “fail forward” in her keynote presentation “Turning High Risk Into High Reward.” Guest speaker Carey Lohrenz, the first female F-14 Tomcat fighter pilot in the U.S.

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Omnicell Controlled Substances Hospitals 52

ISPE

MARCH 8, 2023

These leaders are central to the success of ISPE’s CoPs, which spearhead the generation of ISPE’s gold standard content, including Good Practice Guides, Pharmaceutical Engineering articles, conference presentations, and training programs. The new series follows the CoP profiles series published in the magazine during 2022.

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Controlled Substances 52

The Checkup by Singlecare

APRIL 5, 2023

Opioid medications : Pain relievers like Percocet and Oxycontin (which are controlled substances) improve severe pain, but they also cause constipation, says Dr. Dibba. Dairy intake: Although most people with lactose intolerance present with diarrhea, some may develop constipation as a result of dairy intake, says Dr. Dibba.

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The Checkup by Singlecare

JUNE 16, 2023

In fact, one emergency room study found that adding metaxalone , Zanaflex , or baclofen to the NSAID ibuprofen did not provide better relief of acute lower back pain than the NSAID alone at one week after the presentation. Neither cyclobenzaprine or NSAIDs are on the Drug Enforcement Agency’s (DEA) controlled substance list.

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The Checkup by Singlecare

FEBRUARY 11, 2025

What to consider before taking methocarbamol Methocarbamol is not classified as a controlled substance like some other muscle relaxants, but there are still important things to consider before taking it. And if a person does not want to be drowsy during the day, they may opt to only take it at night.

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Dosage Controlled Substances Communication 52

BuzzRx

JUNE 15, 2020

You do not need to present your medication to the security agent. If you are taking prescription drugs that are controlled substances, for example, opioid pain pills, it’s best to have a doctor’s note explaining your medical conditions and prescriptions. ounces (100 mL).

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The Checkup by Singlecare

FEBRUARY 11, 2025

Its worth noting that both medications are classified as controlled substances by the Drug Enforcement Administration. Thats why Dr. Kelvas says, It’s critical for drugs like this (addictive controlled stimulants) to be given in tandem with cognitive behavioral therapy, or some sort of regular ongoing follow-up.

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Labelling Insurance Controlled Substances FDA 52

The FDA Law Blog

APRIL 21, 2024

Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § 112-029 ), titled “Calculation of 60-Day Period for Application of Patent Term Extension” and referred to by some as “The Dog Ate My Homework Act” or the “Medco Fix.”

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The Checkup by Singlecare

JULY 17, 2023

Most are not controlled substances like diazepam, so there isn’t a risk of drug abuse, addiction, or severe withdrawal symptoms. Don’t forget to present a SingleCare prescription discount card (available on the SingleCare app, text, or physical card) for the most savings. Some are low-priced and have an easier dosing schedule.

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Insurance Controlled Substances Dosage Labelling 52

The Checkup by Singlecare

NOVEMBER 5, 2024

Present it to your pharmacist, and the price of generic zolpidem can drop to $10 for 30, 10 mg pills. Many of the prescriptions for insomnia, including sedative-hypnotics like Ambien , are controlled substances that carry a risk of abuse and withdrawal symptoms.

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Insurance Labelling Insurance Coverage Controlled Substances 52

Pharmaceutical Technology

JUNE 14, 2023

According to GlobalData’s Drugs database, 97% of marketed drugs are small molecule products and analysis shows an increased CMO appetite for specialized capabilities, with controlled substance and containment facilities highly sought after [i]. This is achieved via a controlled vacuum.

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The Nontraditional Pharmacist

AUGUST 19, 2019

So currently I work as one of the project managers and QA engineers for Kit Check, where I primarily work on Bluesight for controlled substances and I’ll go definitely go down exactly what that is. So it’s really cool to have someone like him in a pharmacy software setting.

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BuzzRx

NOVEMBER 11, 2022

In addition, just like any other drugs, some people can develop an anaphylactic reaction to NSAIDs; this is a severe allergic reaction presenting with a skin rash, nausea, vomiting, or swelling of the tongue or throat, causing difficulty breathing. Neither diclofenac nor meloxicam is a controlled substance.

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The Checkup by Singlecare

OCTOBER 29, 2024

mg increments after at least 4 weeks on the present dose up to a maximum of 15 mg once weekly, depending on the treatment response. 15 to 37.5 mg by mouth every morning before breakfast 2.5 mg injected under the skin once weekly for 4 weeks. Then, the dosage is increased to 5 mg once weekly. The dosage may be increased in 2.5

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The FDA Law Blog

FEBRUARY 11, 2025

Houck One of the most significant issues facing hospitals and other facilities is the diversion of controlled substances meant for patients by physicians, pharmacists, nurses and other trusted healthcare employees.

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