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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Omnicell

JANUARY 10, 2023

Direct integration between Omnicell’s medication dispensing systems and the Epic electronic health record system improves the way you manage medications by removing redundant steps from nursing workflow, freeing up time for patient care and increasing medication safety.

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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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Omnicell

JANUARY 12, 2023

While nursing turnover has historically trended below the hospital average across all staff, in 2021 it actually increased 6.4 And if a hospital is still relying on outdated processes for medication retrieval, controlled substance management, and compliance, conditions for burnout are exacerbated.

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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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pharmaphorum

DECEMBER 14, 2022

Harmony Biosciences introduced Wakix to the market in 2019 as the first non-controlled substance for the treatment of narcolepsy. That’s an objectively long time to have exclusivity of a drug that was first synthesised nearly 100 years ago. Competition starts to heat up. Monopoly money.

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Omnicell

JANUARY 10, 2023

Joy Somogyi Senior Director, Product Marketing, Intelligence Solutions In the medical profession, one in ten healthcare workers will abuse controlled substances due to access and availability at work. Diversion in health systems isn't a question of "if," it's a matter of "when." On Tuesday, Oct.

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The Checkup by Singlecare

AUGUST 8, 2024

In 2021 alone, healthcare providers in the United States wrote over 91 million prescriptions for metformin. Because metformin is not a controlled substance, you can obtain a prescription from any licensed healthcare provider. Metformin is a common, affordable medication with mild side effects. Who can prescribe metformin?

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The Checkup by Singlecare

DECEMBER 8, 2022

See the most prescribed drugs of 2021 here. It’s classified as a Schedule II controlled substance due to its high potential for misuse and dependence, explains Dr. Soliman. Pantoprazole sodium (Protonix). Lisinopril/hydrochlorothiazide (Zestoretic). Estradiol (Estrace, Climara, Minivelle). Brand names: Drisdol, Calciferol.

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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

NOVEMBER 20, 2024

In a 2021 study, researchers reported that gabapentin helped reduce colon inflammation in animals. 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 FDA Law Blog

AUGUST 16, 2023

Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information.

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Pharmaceutical Technology

APRIL 12, 2023

Containment and controlled substance capabilities are defining and necessary features for these manufacturing facilities, but not all contract manufacturers have the specialist equipment and capabilities required for high potency small molecule API production.

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The FDA Law Blog

FEBRUARY 27, 2024

These determinations were finalized in 2021. 25, 2021) (“[U]nder the plain statutory language of 35 U.S.C. § 1.750, the PTO takes the position that “Section 156 does not allow for multiple extensions of patents beyond the one patent per one approved product.” See, e.g. , Letter from PTO to FDA CDER, Docket No. FDA-2020-E-1840 (Mar.

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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].

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The Checkup by Singlecare

OCTOBER 8, 2024

Wegovy, which has the active ingredient semaglutide, is a brand-name injectable medication approved by the Food and Drug Administration (FDA) in 2021. Unlike Wegovy, phentermine is a Schedule IV controlled substance. How do Wegovy and phentermine work? It is used for long-term weight loss.

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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. The combined effects of CNS depression from opiates and benzodiazepines can also lead to respiratory depression, increased sedation, or even coma.

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The Checkup by Singlecare

JULY 3, 2024

In 2021, 70.9 At this time, gabapentin isn’t recognized as a controlled substance on the federal level. However, several states have passed laws to classify it as a Schedule V controlled substance. RELATED: What is Gabapentin: Uses, Warnings & Interactions Is gabapentin a controlled substance?

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The FDA Law Blog

MAY 16, 2024

Houck — Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). DEA alleged that UMHS failed to maintain complete and accurate records and failed to timely notify DEA of controlled substance thefts.

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Board Vitals - Pharmacist

JANUARY 9, 2021

As of January 16, 2021) Check with your state’s medical board for the latest updates on pain management and opioid CME requirements. Alabama – 2 Credits The Alabama State Board of Medical Examiners requires 2 credit hours every 2 years on controlled substances for physicians. Hawaii No opioid CME requirements.

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The FDA Law Blog

JANUARY 8, 2023

As a reminder, the Controlled Substances Act (“CSA”) and DEA regulations require that research with cannabis and other schedule I drugs can only be conducted with a protocol approved by DEA and FDA. Such other conduct which may threaten the public health and safety. 21 U.S.C. § Research Protocols. 21 C.F.R. §§ 1301.13(e),

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The Checkup by Singlecare

OCTOBER 25, 2023

Meloxicam is not a controlled substance. It is not considered addictive in the same way as substances like opioids or certain recreational drugs. RELATED: Ace inhibitors vs. beta blockers Sources Meloxicam , National Library of Medicine (2021) Ask the Doctors – How does meloxicam relieve joint pain?

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The Checkup by Singlecare

JUNE 18, 2024

For example, Wegovy is a brand-name drug approved in 2021, while phentermine is a generic drug approved in 1959. Wegovy and phentermine drug warnings Phentermine is a Schedule IV controlled substance that carries a risk of misuse and dependence. Despite their similar uses, Wegovy and phentermine are quite different.

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The Checkup by Singlecare

OCTOBER 15, 2024

According to the drug’s prescribing information, there is a possibility of abuse of phentermine , and because of this risk, the drug is classified as a controlled substance and is typically prescribed at the lowest effective dose for the shortest amount of time needed.

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The FDA Law Blog

APRIL 8, 2024

Specifically, DEA establishes an aggregate production quota (APQ) for each class of controlled substance listed in schedule I and II, and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, which limits the amount of each substance that can be manufactured in a given year.

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The FDA Law Blog

FEBRUARY 11, 2024

Potency has increased since the last scheduling review, with the average tetrahydrocannabinol (“THC”) potency of marijuana seized by DEA spiking from 3.96% in 1995 to 15.34% in 2021. Letter to Attorney General Merrick Garland and Administrator Anne Milgram, from Elizabeth Warren, et al.

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The Checkup by Singlecare

DECEMBER 1, 2023

Dependence Levonorgestrel is not a controlled substance and does not cause dependence or withdrawal symptoms. Planned Parenthood (2021) Plan B One-Step (1.5 Side effects in a nursing infant are not expected when the mother takes a progestin-only drug like Plan B.

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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”). Published 2021 Apr 1. Published 2021 May 28. Published 2021 May 28. Published 2021 Jul 26.

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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”). the “ultimate user”).

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