The Checkup by Singlecare

MARCH 27, 2025

Food and Drug Administration (FDA) for weight management in adults who are overweight or obese. Contrave has an FDA-mandated black box warning due to the risk of suicidal thoughts and behaviors associated with bupropion, the antidepressant ingredient. Tenuate is classified as a Schedule IV controlled substance.

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The FDA Law Blog

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The conference, held in Washington, D.C.,

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The Checkup by Singlecare

MARCH 4, 2025

Adults and pediatric patients 12 years and older Adults 17 years and older Qsymia vs. phentermine: Conditions treated Qsymia is approved by the Food and Drug Administration (FDA) for weight loss and long-term weight management in adults and pediatric patients 12 years and older with obesity. of body weight compared to 13.7%

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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.” The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. 72,694, 72,703 (Dec.

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The FDA Law Blog

MAY 31, 2023

However, until today there had been no public information about this decision. On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlled substances.

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The FDA Law Blog

FEBRUARY 19, 2023

Mr. Houck’s session will address pharmacists’ corresponding responsibility to identify and resolve controlled substance prescribing red flags and how to prepare for and manage DEA inspections. The session will occur Friday, March 24th. Pharmacists can earn 1 continuing practice education credit for attending this session.

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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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The Checkup by Singlecare

MAY 1, 2024

It is a Drug Enforcement Administration (DEA) controlled substance in the Schedule II category. Non-amphetamine-based ADHD treatments, such as Strattera , are not controlled substances. Food and Drug Administration (FDA) in 2007 for treatment and symptom control in ADHD.

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The Checkup by Singlecare

DECEMBER 20, 2024

Tizanidine is a generic prescription muscle relaxant available as brand-name Zanaflex, which is approved by the Food and Drug Administration (FDA) for treating spasticity , a condition in which muscles stiffen or tighten, preventing normal fluid movement. Tizanidine is also used off-label (for a non-FDA-approved use) for musculoskeletal pain.

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The Checkup by Singlecare

SEPTEMBER 7, 2023

The goal of quantity limits is to make sure that prescription drugs, especially those that could be misused or cause an overdose (like controlled substances ), are used properly and safely. These limits are set using advice from the Food and Drug Administration (FDA) and the drug makers’ suggestions.

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The Checkup by Singlecare

MAY 29, 2024

Adderall is a Schedule II Controlled Substance per the Drug Enforcement Administration (DEA),” explains Shawn Rowland, MD , founder and CEO of Jase Medical. “It It is safe for Americans to buy Adderall online from a legal internet pharmacy that is allowed to dispense controlled substances.

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The Checkup by Singlecare

JUNE 11, 2024

Food and Drug Administration ( FDA ) approved it to treat cases of moderate to severe pain. It is classified as a Schedule IV controlled substance, according to the Controlled Substances Act. Tramadol is sold under the brand names Ultram, Ultram ER, and Conzip, and also in generic form. In 2014, the U.S.

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The Checkup by Singlecare

OCTOBER 9, 2024

While Ozempic ( semaglutide ) and Adderall (amphetamine/dextroamphetamine) aren’t FDA -approved weight loss drugs , healthcare providers sometimes prescribe these medications off-label to help with weight management. In fact, semaglutide is FDA -approved for weight loss under the brand name Wegovy.

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The Checkup by Singlecare

AUGUST 8, 2024

This information helps determine if metformin is right for you and to help avoid any medical interactions. After analyzing this information, your doctor may prescribe the drug if you have Type 2 diabetes or prediabetes along with obesity. Diabetes There aren’t any FDA-approved OTC drugs for diabetes. Who can prescribe metformin?

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The Checkup by Singlecare

AUGUST 15, 2024

Food and Drug Administration (FDA) for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity in those who meet the defined body mass index (BMI) criteria. This would be off-label use of the medications because the FDA approves neither for weight loss. Contrave is approved by the U.S.

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The FDA Law Blog

NOVEMBER 6, 2023

Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage: Robert A. Niche practices in new drug development, controlled substances, advertising, and health care law complement our core FDA practice.

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The FDA Law Blog

AUGUST 16, 2023

By Dara Katcher Levy — Well, if you, like many within industry, felt emboldened to disseminate promotional materials that may push the envelope on efficacy (so long as your risk information was tight) think again! Let’s go over some background information relating to Breztri and the OPDP Warning Letter. Pretty egregious stuff, right?

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SingleCare

NOVEMBER 17, 2021

Telehealth companies may also provide a secure mobile app to exchange personal health data, medical history notes, diagnostic images, and other information with your provider. For example, prescriptions for controlled substances like Adderall or Ritalin are not typically available through an online doctor.

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The FDA Law Blog

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. This means that there multiple same-day FDA NDA approvals for the same drug.

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The FDA Law Blog

MARCH 9, 2023

We prepare a report that we share with our client and make a recommendation to our client about whether to disclose the information to FDA. We pledge to cooperate with FDA, and we plead with FDA to recognize that we engaged in a thorough investigation and provided a full disclosure. And, FDA still doesn’t.

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The Checkup by Singlecare

NOVEMBER 6, 2024

Since dexmethylphenidate has the potential for abuse and misuse, Azstarys is a controlled substance, and the Food and Drug Administration requires Azstarys to be sold with a boxed warning. Azstarys was FDA approved in 2021. The cost of Azstarys without insurance can vary depending on the dosage and pharmacy location. “It

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The Checkup by Singlecare

DECEMBER 10, 2024

Weve got all the important information for both situations belowincluding side effects and Adderall alternatives. It can make symptoms worse Adderall isnt FDA-approved for OCD treatment, and doctors dont prescribe it off-label either. Is Adderall one of them? Its complicated. Does Adderall help with OCD?

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The Checkup by Singlecare

AUGUST 29, 2023

It’s FDA approved for the treatment of ADHD and narcolepsy, but it’s sometimes prescribed off-label as a weight loss drug. It’s a Schedule II controlled substance, so it can lead to a substance use disorder if it’s misused, but that’s rarely seen in people using therapeutic doses of the drug for ADHD as prescribed by a provider.

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The FDA Law Blog

FEBRUARY 27, 2023

In a case involving a challenge to a Freedom of Information Request (“FOIA”) submitted to DEA, the DOJ and DEA appear to now argue that DEA is a “component” of the DOJ and not an agency. The arguments in this case also highlight a longstanding frustration with obtaining FOIA information from the DEA. Aims Institute, PLLC, v.

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The Checkup by Singlecare

DECEMBER 30, 2024

Due to the risk of substance abuse on this medicine, some may wonder if Soma is considered a controlled substance. Is Soma a controlled substance? Soma is a controlled substance, but only medications belonging to the opioid drug class are considered narcotics. Soma is not a narcotic.

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The Checkup by Singlecare

JUNE 16, 2023

Cyclobenzaprine , an FDA -approved prescription medication, has long been a go-to muscle relaxant for short-term use for muscle spasms and pain relief. You will need more information to take to your healthcare provider for medical advice. Is your low back spasming for some reason and causing acute low back pain ?

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The Checkup by Singlecare

DECEMBER 8, 2022

Although it’s approved by the Food and Drug Administration (FDA) for the treatment of hypothyroidism, Dr. Soliman explains that it’s often used for off-label issues like low energy and goiter. . “Inform your healthcare provider if you start to experience a dry cough, which is a common side effect of lisinopril.”

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The Checkup by Singlecare

MARCH 30, 2023

Control your controls If your biennial controlled substance inventory is due this year, now is the time to start preparing. Ensure all controlled substances are stored properly. For example, over-the-counter hearing aids are now FDA-approved—is your pharmacy stocked and ready?

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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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The FDA Law Blog

APRIL 17, 2024

Additional information about DEA’s National Prescription Drug Take Back Day, including local disposal venues, can be found here. Events over the years have led to the removal of more than 17.9 million pounds of unwanted medication across the country. Clear that Cabinet Tour ’24…Don’t you dare miss it!

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The Checkup by Singlecare

NOVEMBER 5, 2024

Often referred to by its brand name Ultram , tramadol is an opioid medication that’s classified as a schedule IV controlled substance due to its potential for physical dependence , abuse, and addiction. Tramadol is an opioid pain medication that’s FDA-approved to treat moderate-to- severe pain that isn’t managed by other treatments.

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The Checkup by Singlecare

OCTOBER 15, 2024

Tramadol –which is commonly referred to by its brand name Ultram –is a generic opioid medication that’s approved by the Food and Drug Administration ( FDA ) for moderate-to- severe pain that’s unmanaged by alternative treatments. It’s classified as a Schedule IV controlled substance due to its potential for misuse, abuse, and addiction.

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The Checkup by Singlecare

JUNE 22, 2023

How to get lorazepam without insurance Lorazepam is an FDA-approved generic prescription drug to treat anxiety disorders and insomnia. People with commercial health insurance, Medicaid , and Medicare Part D are usually covered for lorazepam as long as it’s used for FDA-approved medical conditions. Is lorazepam covered by insurance? |

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DiversifyRx

OCTOBER 26, 2023

If you receive a prescription for a controlled substance like Suboxone, you must have an X-DEA number. Benefit checks provide essential information about drug coverage without revealing reimbursement amounts, allowing you to work collaboratively with patients and prescribers to find suitable covered therapeutic options.

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The FDA Law Blog

JULY 1, 2024

For each factor, the NPRM noted that for DEA , additional information during the rulemaking w ould inform about the appropriate schedule for marijuana. T he NPRM , however, noted that DEA “has not yet made a determination as to its views of the appropriate schedule for marijuana.” Id.

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BuzzRx

DECEMBER 2, 2022

Vyvanse is a schedule II controlled substance, meaning it can be habit-forming with high risk of drug abuse. Some examples of FDA-approved monoamine oxidase inhibitors to treat depression are phenelzine (Nardil), isocarboxazid ( Marplan ), and tranylcypromine (Parnate). References: [link] [link] [link].

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The Checkup by Singlecare

JANUARY 19, 2023

This can be a serious concern, especially if the medications are potentially toxic or controlled substances. It’s also a good idea to remind patients to remove or block out any personal or identifying information on the prescription container before throwing it away or recycling it.

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