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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Controlled Substances Compounding Immunity Immunization 98

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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Controlled Substances 111

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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Controlled Substances 116

FDA Law Blog: Biosimilars

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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Labelling Controlled Substances 59

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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Controlled Substances Compounding 52

Integra X Files

FEBRUARY 20, 2023

The Kaiser Family Foundation estimates that, of the 20 million people who gained Medicaid coverage between 2019 and 2022, about six percent are aged or disabled. The ability to prescribe controlled substances without an in-person consultation will end with the expiration of the PHE.

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Nursing Homes Vaccines Controlled Substances Hospitals 89

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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Controlled Substances 52

National Association of Boards of Pharmacy

SEPTEMBER 18, 2023

The United States is home to one of the most secure drug supply chains in the world, but criminals still find pathways to buy and sell prescription drugs—including controlled substances—often using websites and social media platforms to do so. All demographics are susceptible to the harm of online pharmacies.

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Online Pharmacies Controlled Substances 85

National Association of Boards of Pharmacy

SEPTEMBER 27, 2023

In 2022 alone, our team performed almost 900 on-site inspections and surveys! The major components that the team looks for during a site visit are: controlled substance security, temperature control, cleanliness, business continuity and disaster planning, and who the business is buying from and selling to.

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Sterile Compounds Controlled Substances Compounding Hospitals 59

FDA Law Blog: Biosimilars

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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Labelling Controlled Substances Communication 52

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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Packaging Controlled Substances Documentation Pharmaceutical Companies 59

FDA Law Blog: Biosimilars

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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Controlled Substances Hospitals 59

Proxsys Rx

JULY 5, 2023

It’s a still-unfinished process that began when we reached our agreement with HMC in March, 2022. Our next regulatory challenge was gaining approval from Cardinal CSMP (Controlled Substance Monitoring Program). Until recently, that process (given ProxsysRx’s history and record) was close to a Rubber Stamp matter.

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Hospitals Inpatient Prescription Filling Controlled Substances 52

FDA Law Blog: Biosimilars

MAY 21, 2024

Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K. 44,597 (May 21, 2024). 29, 2023) (“Basis”); NPRM at 44,603.

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Controlled Substances Chemotherapy Dosage Labelling 69

FDA Law Blog: Biosimilars

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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Controlled Substances 111

FDA Law Blog: Biosimilars

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.,

Controlled Substances 52

Controlled Substances 52

FDA Law Blog: Biosimilars

APRIL 8, 2024

In 2022, the Government Accountability Office (GAO) reported that FDA needed to improve its foreign inspection program and that report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. However, the White Paper does not acknowledge the role that DEA plays.

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Inpatient Hospitals Dosage Controlled Substances 59

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 2022 Feb 17. Published 2022 Oct 14. Published 2020 Aug 18. 2022;27(4):1351. Front Nutr.

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Diabetes Immunity Immunization Compounding 75

FDA Law Blog: Biosimilars

DECEMBER 14, 2023

In October 2022 President Biden asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” As explained more fully explained below, that impression would be partially correct, but partially incorrect.

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Controlled Substances Packaging Labelling Hospitals 59

FDA Law Blog: Biosimilars

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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Controlled Substances Chemotherapy Dosage Labelling 95

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Five of the senators (Elizabeth Warren, Cory Booker, Bernie Sanders, Kristen Gillibrand, and Ron Wyden) wrote to the Attorney General, President Joe Biden, and HHS Secretary Xavier Becerra in July 2022, urging cannabis descheduling and pardons for those convicted of non-violent cannabis-related offenses. July 6, 2022).

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Controlled Substances Chemotherapy Compounding 59

FDA Law Blog: Biosimilars

APRIL 29, 2024

Later Democratic lawmakers, eleven senators and ten members of Congress, also penned a letter to Administrator Milgram and Attorney General Merrick Garland imploring DEA to not only “promptly remove marijuana” from schedule I of the Controlled Substances Act (“CSA”), but to deschedule it altogether. April 24, 2024.

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Controlled Substances 59