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. §

Controlled Substances 116

Controlled Substances Documentation 116

Omnicell

SEPTEMBER 5, 2022

One area where interoperability specifically helps is the management of controlled substances. When it comes to managing diversion, interoperability supports a tightened chain of custody across the controlled substance journey. That’s time gained to now spend on direct patient care.

Controlled Substances 98

Controlled Substances Omnicell Patient Care Hospitals 98

The FDA Law Blog

JUNE 10, 2024

Houck — It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. DOJ, Iowa Surgical Center Agrees to Pay $125,000 to Resolve Allegations It Violated the Controlled Substances Act ( June 4, 2024 ). By Larry K.

Controlled Substances 59

Controlled Substances Hospitals Medication Dispensing 59

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.

Controlled Substances 98

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).

Controlled Substances 64

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.

Controlled Substances 59

Controlled Substances Immunization 59

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.

Controlled Substances 52

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.

FDA 98

FDA Controlled Substances 98

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).

Controlled Substances 52

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.

Health and Personal Care Stores 105

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.

Controlled Substances 52

Controlled Substances Documentation 52

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.

Controlled Substances 40

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.

Controlled Substances 98

Controlled Substances Compounding Immunization 98

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.

Controlled Substances 59

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. §

Controlled Substances 59

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.

Controlled Substances 40

Controlled Substances 40

Pharmaceutical Technology

MAY 9, 2023

There is also the possibility of false-positive results when methamphetamine and related substances are present. “We Interactions with other substances and the chance of false positives related to sample dilution are things to consider with xylazine strips moving forward.”

Controlled Substances 111

Controlled Substances FDA 111

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.

Controlled Substances 81

Controlled Substances Labelling Dosage FDA 81

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.

Independent Pharmacies 40

Independent Pharmacies Controlled Substances Patient Care 40

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.

Controlled Substances 52

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?

Controlled Substances 105

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.

Mail-Order Pharmacies 52

Mail-Order Pharmacies Controlled Substances Insurance Specialty Pharmacies 52

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.

Omnicell 52

Omnicell Hospitals Controlled Substances 52

OctariusRx

AUGUST 8, 2022

Controlled substance management. This includes all non-hazardous medications, hazardous medications and controlled substances. Hazardous and controlled substances alone are highly regulated by various agencies and require specific processes to remain compliant. Providing guidance on disposal of medications.

Controlled Substances 58

Controlled Substances Compounding Vaccines Compounding Pharmacies 58

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.

Controlled Substances 84

Controlled Substances Dosage 84

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.

FDA 52

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.

Omnicell 52

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.

Omnicell 52

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.

Controlled Substances 52

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.

Mayo Clinic 98

Mayo Clinic Controlled Substances 98

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.

Controlled Substances 52

Controlled Substances Dosage FDA 52

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.

Dosage 52

Dosage Controlled Substances Communication 52

The Checkup by Singlecare

MAY 8, 2023

It is associated with less histamine release than other opiates, which presents as a pseudoallergy , so it is a recommended alternative to opiates should this reaction of itching, flushing, and sweating occur. In contrast, subacute pain has been present for one to three months, and chronic pain is pain experienced for more than three months.

Controlled Substances 52

Controlled Substances Dosage Labelling FDA 52

BuzzRx

JANUARY 19, 2023

Lunesta is a schedule IV controlled substance. As a schedule IV controlled substance, Lunesta has a low potential for abuse and a low risk for dependence. People in these populations need to use extra caution to prevent a fall, which can lead to accidental injury and disability. What are the risks of taking Lunesta?

Controlled Substances 52

Controlled Substances Dosage 52

The Checkup by Singlecare

MARCH 1, 2023

Phentermine is a Schedule IV controlled substance , which means it may have the potential for abuse leading to psychological or physical dependence. It is not known if phentermine is present in human milk; therefore, it is not recommended to breastfeed while taking the medication.

Controlled Substances 52

Controlled Substances Adverse Reactions FDA Dosage 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).

Controlled Substances 52

Controlled Substances Packaging Labelling 52

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.

Labelling 52

Labelling Insurance Controlled Substances FDA 52