The FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA. 21 U.S.C. §

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The FDA Law Blog

AUGUST 21, 2023

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). 16, 2023 ( DOJ Press Release ).

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Pharmaceutical Technology

DECEMBER 5, 2022

Cannabinoid-based drugs are derived from compounds found in the cannabis plant. However, at the federal level, cannabinoids remain illegal under the Controlled Substances Act. Despite this, the medical use of cannabinoid drugs is heavily restricted, including being banned in 137 countries, according to the United Nations.

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The FDA Law Blog

NOVEMBER 15, 2022

He also held leading roles in DOJ’s response to multiple significant national health crises, including the COVID-19 pandemic, the 2019 EVALI vaping crisis, and the 2012 New England Compounding Center fungal meningitis outbreak.

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OctariusRx

NOVEMBER 20, 2023

Earlier this year, we discussed Nursing Medication Calculations, Medication safety and Controlled Substances to help your staff hone their skills and let you assess their abilities. As usual, the quiz is continually updated and comes with a complete answer key to make grading easier.

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The Happy PharmD

OCTOBER 11, 2024

Compounding its challenges, Rite Aid became entangled in legal issues, notably linked to the opioid crisis. Allegations of improper handling of controlled substances and subsequent legal battles resulted in significant penalties and loss of trust from vendors and customers alike.

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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.

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OctariusRx

JUNE 5, 2023

Compounded Drugs: Will your facility use compounded drugs? Is the pharmacy providing the compounded drugs an FDA registered 503B outsourcing facility ? Is the pharmacy providing the compounded drugs an FDA registered 503B outsourcing facility ? According to a 2019 report from the U.S.

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The Checkup by Singlecare

OCTOBER 25, 2023

a compounding pharmacist at Pharmedico in Sarasota, Florida. Meloxicam is not a controlled substance. It is not considered addictive in the same way as substances like opioids or certain recreational drugs. It is in the same drug class as ibuprofen , aspirin , naproxen , and diclofenac.

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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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The Checkup by Singlecare

MARCH 23, 2023

Understanding the difference between CBD vs. marijuana Cannabinoids are compounds found in the cannabis plant, Cannabis sativa. The United States Congress legalized CBD derived from hemp in 2018 when the Agricultural Improvement Act was signed into law, removing hemp from the Federal Controlled Substances Act.

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The Checkup by Singlecare

JULY 20, 2024

If you’re giving the cat liquid tramadol, measure the medicine with a device supplied by the veterinarian or the compounding pharmacy. Tramadol oral solution should be stored according to the instructions given by the compounding pharmacy. Do not use kitchen utensils or tableware. If a dose is missed, skip the missed dose.

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Pharmaceutical Technology

NOVEMBER 17, 2022

According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities. However, site selection and facility acquisition can be a challenge, as well as being a major capital expenditure (CAPEX).

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OctariusRx

JUNE 7, 2022

Compounded Drugs: Will your facility use compounded drugs? Is the pharmacy providing the compounded drugs an FDA registered 503B outsourcing facility ? Is the pharmacy providing the compounded drugs an FDA registered 503B outsourcing facility ? According to a 2019 report from the U.S.

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Omnicell

JANUARY 10, 2023

With the advancement of diversion software and the ability for closed loop interoperability , the manual process can be eliminated , allow ing hospital systems – not only in nursing but pharmacy – to accurately evaluate controlled substance management.

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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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Druggist

JULY 22, 2020

Phenergan Elixir is an oral sedative antihistamine licensed for the management of allergic conditions of the upper respiratory tract including a runny nose, allergies affecting the skin and anaphylactic reactions to drugs and other compounds. Is promethazine cough syrup a controlled substance?

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The Checkup by Singlecare

FEBRUARY 8, 2024

Alternatively, a compounding pharmacy can make smaller-dose tablets or an oral solution. If the dog is being given an oral solution, measure the medicine with a measurement device supplied by the veterinarian or the compounding pharmacy. As a controlled substance, it may be best to keep it locked up.

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indispensable health

JANUARY 11, 2022

I spent time working in a community pharmacy and a compounding pharmacy. . “ My Name is Stephanie Everard and I am a Pharmacist Team Member with Indispensable Health ” — Stephanie Everard, PharmD. Stephanie, when did you become interested in pharmacy? I became interested in pharmacy in high school.

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The Checkup by Singlecare

MAY 24, 2024

It is a federally controlled substance because of the risk of physical dependence, tolerance, withdrawal, abuse, and overdose. Diazepam is the drug of choice for metronidazole toxicity , but it’s not an ideal drug for increasing a dog’s appetite because of its adverse effects. Is diazepam safe for dogs?

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The Checkup by Singlecare

NOVEMBER 20, 2024

Sometimes, nervous system inflammation can cause or compound this nerve pain. Although it’s not federally classified as a controlled substance , there is still some risk, which can lead to withdrawal symptoms like anxiety, nausea, trouble sleeping, pain, and sweating if stopped suddenly.

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The Checkup by Singlecare

DECEMBER 10, 2024

But while OCD stimulates activity in this system, ADHD reduces it, which is why Adderall isnt always a solution for OCD on its own and can compound the problem. Its a Schedule II controlled substance , which puts it into the same category as cocaine, oxycodone, and fentanyl.

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The Checkup by Singlecare

AUGUST 17, 2024

Compounded veterinary formulations include tablets, oral suspension, and an oil-based suspension. Clonazepam is a controlled substance. Human-formulated clonazepam also comes as an orally disintegrating tablet, but it’s difficult to dose a dog with these tablets, and they may contain xylitol, which should not be used in dogs.

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The Checkup by Singlecare

JULY 30, 2024

mg/kg single intravenous injection Lorazepam is not FDA-approved for animal use, so pet owners will use human-formulated versions or lorazepam specially formulated by a compounding pharmacy. Lorazepam is a controlled substance. mg/kg given one to three times a day For status epilepticus: 0.2 mg, 1 mg, and 2 mg.

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European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured.

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The FDA Law Blog

JANUARY 8, 2023

As discussed in more detail below, the Act facilitates research of cannabis and its derivatives including cannabidiol (“CBD”), extracts, preparations and compounds, and the development of approved medications. Federal Research. Such other conduct which may threaten the public health and safety. 21 U.S.C. § Research Protocols.

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The FDA Law Blog

JUNE 23, 2024

Palmer — For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. 2] Why is this an issue? the “ultimate user”).

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The Thyroid Pharmacist

NOVEMBER 15, 2024

I also prefer semaglutide drugs over other weight loss drugs out there (for example, phentermine, a controlled substance that can be habit forming, or orlistat, a drug that results in fat malabsorption and “disaster pants”). Berberine Berberine is a natural compound found in several plants, including goldenseal and barberry.

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The FDA Law Blog

FEBRUARY 11, 2024

Few would oppose FDA-approved marijuana-derived medications if marijuana compounds are found to have medical value; the National Institute of Health should continue to fund research on any potential medical value of marijuana and on the harms of highly potent products.

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