The Happy PharmD

APRIL 26, 2023

I was a staff pharmacist working in my first hospital. I liked working as a staff pharmacist in a hospital. Most of them were written by residents in the hospital. I have been in hospital pharmacy management for over thirty years. As a hospital pharmacy manager, I have been in the medical field for over thirty years.

Dosage 52

Dosage Hospitals Pharmacy Technician Prescription Filling 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

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. FDA-2022-E-3123 and FDA-2022-E-3120) with respect to U.S. Patent Nos. 7,214,695 and 7,214,696.

Controlled Substances 59

Controlled Substances Hospitals 59

FDA Law Blog: Biosimilars

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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Controlled Substances Hospitals Intravenous Solutions 59

epicur

APRIL 24, 2024

Get My Copy Do you see any differences in inventory management guidelines depending on the veterinary practice – a large hospital vs a smaller private practice? For critical medications like controlled substances, it becomes a scramble to find something. I would say so, yes.

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Compounding Controlled Substances Communication Online Pharmacies 40

FDA Law Blog: Biosimilars

FEBRUARY 11, 2025

Houck One of the most significant issues facing hospitals and other facilities is the diversion of controlled substances meant for patients by physicians, pharmacists, nurses and other trusted healthcare employees. Click here to learn more about the Opioid & Abuse Management Congress.

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Controlled Substances Hospitals 59

FDA Law Blog: Biosimilars

SEPTEMBER 12, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

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Controlled Substances Hospitals 49

FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

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Controlled Substances Hospitals 45

FDA Law Blog: Biosimilars

JUNE 10, 2024

Houck — It seems as though we cannot get through a week without hearing about controlled substance diversion by employees at another hospital or healthcare facility. DEA, Palomar Hospital Pays $250,000 for Diverting Fentanyl ( June 3, 2024 ). By Larry K.

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Controlled Substances Hospitals Medication Dispensing 59

FDA Law Blog: Biosimilars

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.

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Controlled Substances Chemotherapy Compounding Dosage 69

National Association of Boards of Pharmacy

JULY 12, 2023

Prior to my role as an inspector, I spent 2 1/2 years as a pharmacy manager/clinical pharmacist at a small hospital in Virginia and 7 1/2 years as a pharmacy manager at an independent retail pharmacy in Virginia.   I have served 3 years as a pharmacy inspector in the enforcement division of the Virginia Department of Health Professions.

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Pharmacy Technician Pharmacy Management Controlled Substances Communication 96

National Association of Boards of Pharmacy

SEPTEMBER 27, 2023

Before coming to NABP, I worked in various hospital pharmacy settings and served on the State of Ohio Board of Pharmacy as a Compliance Specialist. In this blog, she shares stories from her career and how the NABP accreditation and inspection team works to protect public health.

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Sterile Compounds Controlled Substances Compounding Hospitals 59

FDA Law Blog: Biosimilars

APRIL 8, 2024

To address the underlying causes of shortages, the White Paper suggests that the creation (by Congress) of two programs that link inpatient hospital purchasing and payment decisions to supply chain resilience practices would better incentivize investments in mature manufacturing practices.

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Inpatient Hospitals Dosage Controlled Substances 59

Integra X Files

FEBRUARY 20, 2023

Key Provisions of the PHE for Nursing Homes The most visible effect of the PHE for nursing homes was suspension of the requirement for a three-day stay in an acute care hospital before qualifying for Medicare Part A coverage for a SNF stay. The suspension made it easier to get skilled care for those who needed it.

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Nursing Homes Vaccines Controlled Substances Hospitals 89

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

National Association of Boards of Pharmacy

OCTOBER 11, 2023

Buprenorphine Legislation: From the X Waiver to the MAT Act The Drug Addiction Treatment Act of 2000 waiver, also known as the DEA X-waiver, allowed clinicians to prescribe buprenorphine, a controlled substance medication, to treat opioid dependency.

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Controlled Substances Independent Pharmacies Hospitals 45

FDA Law Blog: Biosimilars

DECEMBER 14, 2023

They contended that access to cannabis is associated with reduced rates of: Opioid use and abuse; Opioid-related hospitalizations; Opioid-related traffic fatalities; Opioid-related drug treatment admissions; and Opioid-related overdose deaths. Citing a DEA publication, the governors asserted that “cannabis use killed no one.”

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Controlled Substances Packaging Labelling Hospitals 59