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.” By Larry K. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec. 50,372 at 50,372-73. 21 U.S.C. § 824(a).

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pharmaphorum

SEPTEMBER 5, 2022

According to Kasada, in April 2022 its threat intelligence observed the use of credential stuffing – the automated injection of stolen username and password pairs into a website’s login form – to attack pharmacies, steal active customer accounts, and exploit them for the distribution of prescribed medications.

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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

In 2022, a surge in the pipeline has led to cannabinoid receptors becoming the most popular target in preclinical development. However, at the federal level, cannabinoids remain illegal under the Controlled Substances Act. However, access is restricted, requiring a special permit given under exceptional circumstances.

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Omnicell

JANUARY 12, 2023

That’s what an average US hospital loses due to nursing turnover, according to the 2022 NSI National Health Care Retention & RN Staffing Report. And if a hospital is still relying on outdated processes for medication retrieval, controlled substance management, and compliance, conditions for burnout are exacerbated.

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pharmaphorum

DECEMBER 14, 2022

Avadel Pharmaceuticals developed Lumryz, a sodium oxybate that is a once-daily, extended-release oral suspension that gained tentative FDA approval in July 2022. Harmony Biosciences introduced Wakix to the market in 2019 as the first non-controlled substance for the treatment of narcolepsy. Competition starts to heat up.

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The Checkup by Singlecare

APRIL 18, 2025

Erectile dysfunction isnt listed as a potential side effect on the Neurontin label, but one study from 2011 links gabapentin to sexual dysfunction, and a 2022 review of the FDA Adverse Event Reporting System found over 130 cases of gabapentin-induced erectile dysfunction over 10 years. What are the long-term side effects of gabapentin?

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The Happy PharmD

OCTOBER 11, 2024

Over the decades, it transformed into a pharmacy powerhouse, expanding through strategic acquisitions to over 2,000 stores by 2022. 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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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. § Rather, “permission for commercial marketing” was only effective upon FDA’s issuance of its corrected October 5, 2022 letter. That’s important, because PTE applications for U.S. Patent Nos.

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The FDA Law Blog

APRIL 6, 2025

Andrew draws on his government experience investigating and prosecuting violations of the FDC Act, the Controlled Substances Act, the False Claims Act, and other federal healthcare laws to now represent clients facing those issues. Julie Kims 2022 law school graduation year belies her experience.

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Board Vitals - Pharmacist

SEPTEMBER 3, 2022

As of November 2022, there are more than 355,000 nurse practitioners licensed in the US. 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. The nurse practitioner (NP) role is a popular one.

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The Checkup by Singlecare

MARCH 23, 2023

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. However, at the federal level, marijuana is still classified as a Schedule I controlled substance by the Drug Enforcement Agency (DEA).

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The Checkup by Singlecare

OCTOBER 9, 2024

It is not approved in adults directly as a sleep aid, but it is often used ‘off-label’ as a non-controlled substance that aids in sleep,” explains Dr. Sulagna Misra, MD, BCMAS, founder of Misra Wellness. Food and Drug Administration (FDA) does not approve clonidine as a sleep aid. “It

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ISPE

MARCH 8, 2023

The new series follows the CoP profiles series published in the magazine during 2022. The project required us to pack and blind a controlled substance, export from the US, and then re-export to multiple European countries, blinding at the very last stage of processing.

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The Checkup by Singlecare

NOVEMBER 20, 2024

A separate study from 2022 concluded that pregabalin (similar to gabapentin) is a safe and effective treatment for OA , but researchers said proving its efficacy would require a larger sample size. There have been a few different studies concerning gabapentin’s effectiveness as a knee OA treatment.

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The FDA Law Blog

AUGUST 16, 2023

The last Warning Letter OPDP issued was in early 2022 to CytoDyn for promoting its investigational drug as an effective treatment for COVID-19 despite a failed study (and despite an FDA release issued a year prior about the same failed study – but that’s another story ).

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Pharmaceutical Technology

SEPTEMBER 23, 2022

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. Avéma’s newest facility in Miami, which will come online in October 2022, will add 135,000 sq. Continuous investment.

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The FDA Law Blog

OCTOBER 12, 2022

Naloxone is a prescription drug, but unlike some other prescription drugs used in the treatment of opioid addiction such as buprenorphine , it is not a controlled substance. Because naloxone is a prescription drug, its distribution is subject to the requirements of the Drug Supply Chain Security Act (DSCSA).

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The FDA Law Blog

FEBRUARY 27, 2023

4:2022-cv-02396 S.D. The DEA has even made the same mistake. Default Provisions for Hearing Proceedings Relating to the Revocation, Suspension, or Denial of a Registration; Correction , 87 Fed. 73246 (Nov. Aims Institute, PLLC, v. Merrick Garland, et. al , Case No.

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The FDA Law Blog

OCTOBER 19, 2022

If you need more motivation to clean out your cluttered medicine cabinet, the Drug Enforcement Administration (“DEA”) and its law enforcement partners are hosting thousands of local drop-off locations nationwide for proper disposal of unneeded medication on Saturday, October 29, 2022, from 10 am to 2 pm local time.

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The FDA Law Blog

FEBRUARY 27, 2024

FDA-2022-E-3123 and FDA-2022-E-3120) with respect to U.S. The second multiple PTE case brewing concerns FoldRx’s (a wholly owned subsidiary of Pfizer, Inc.) Two PTE applications were submitted to FDA ( See FDA Docket Nos. Patent Nos. 7,214,695 and 7,214,696.

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The Checkup by Singlecare

AUGUST 21, 2024

Quviviq is a newer drug, with its first approval in 2022. Quviviq and Belsomra are Schedule IV controlled substances. Belsomra is manufactured by Merck Sharp & Dohme and contains suvorexant. Belsomra was the first DORA, approved by the Food and Drug Administration (FDA) in 2014. They carry a risk of abuse and dependence.

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The Checkup by Singlecare

AUGUST 5, 2023

As there is currently a drug shortages of Adderall in the United States, which has been ongoing since October of 2022, more healthcare providers may prescribe the generic alternative. The generic version is produced by various manufacturers, including Sandoz, Aurolife, and Zydus Pharmaceuticals.

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The Checkup by Singlecare

OCTOBER 29, 2024

Mounjaro is a brand-name drug approved in 2022 that contains the active ingredient tirzepatide. It is also classified as a stimulant that helps people feel less hungry, making them eat less. As a result, it directly helps promote weight loss. It works as a dual GIP and GLP-1 receptor agonist.

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The Checkup by Singlecare

NOVEMBER 14, 2022

It is a Schedule IV controlled substance. In October 2022, the FDA gave Mounjaro a Fast Track designation to be studied for weight loss. Phentermine works by decreasing the appetite (an appetite suppressant) which helps in reducing food cravings and increasing your metabolic rate to aid in fat loss.

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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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The FDA Law Blog

SEPTEMBER 5, 2023

Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.;

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The FDA Law Blog

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. Statement from President Biden on Marijuana Reform, White House (Oct.

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The FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. 2022 Guideline”). 2022 Guideline at 15. (We An important part of the 2022 Guideline includes CDC’s pronouncement that some laws, regulations and policies have misapplied the 2016 guidelines and likely contributed to patient harm.

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Pharmaceutical Technology

MAY 9, 2023

This followed in the wake of a Drug Enforcement Agency (DEA) Joint Intelligence Report in October 2022, which stated that xylazine is widely available from Chinese suppliers on the internet. There have been calls to make xylazine a scheduled drug in the US, but so far only three states have classified it as a controlled substance.

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The Checkup by Singlecare

JANUARY 15, 2024

Drescher notes that not every healthcare professional will feel comfortable prescribing certain controlled substances to patients with depression. appeared first on The Checkup.

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The FDA Law Blog

JANUARY 8, 2023

See President Biden Gives the Green Light for Significant Marijuana Reform, October 10, 2022. 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. Federal Research. 21 U.S.C. §

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BuzzRx

SEPTEMBER 16, 2022

Are schedule IV controlled substances due to their potential for misuse, abuse, and addiction. Both Valium and Ativan are Schedule IV controlled substances because they have some potential for abuse and dependence. Retrieved August 17, 2022, from [link] Diazepam. Retrieved August 17, 2022, from [link].

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The FDA Law Blog

DECEMBER 21, 2023

In October 2022 President Joseph Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General to begin the administrative process of reviewing expeditiously how cannabis is scheduled under federal law. By Hyman, Phelps & McNamara, P.C. — Hyman, Phelps & McNamara, P.C.,

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The Checkup by Singlecare

DECEMBER 10, 2024

A 2022 study looked at whether treating sleep disorders with benzodiazepines, compared to other medications like trazodone, hydroxyzine, and Z-drugs (zolpidem, zaleplon, eszopiclone), increases the risk of drug overdose in young people. Don’t stop using any medications without consulting your healthcare provider first.

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The Checkup by Singlecare

OCTOBER 15, 2024

According to the National Institute on Drug Abuse , overdose deaths involving opioid use rose from 21,089 in 2010 to 81,806 in 2022. The US Drug Enforcement Agency (DEA) hasn’t labeled it a controlled substance at the federal level, but several states have. This is important because opioid addiction is an epidemic in the U.S.

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The Checkup by Singlecare

DECEMBER 26, 2023

The FDA has classified testosterone drugs as Schedule III controlled substances because of their potential for abuse and dependency. Healthcare professionals will monitor for these changes and discontinue testosterone treatment if they occur. Does testosterone cause drug abuse or dependency?

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