2025 and Controlled Substances

Prescribing Red Flags: Pharmacists Be Wary of What the Doctor Orders

FDA Law Blog: Biosimilars

MAY 19, 2025

Attorneys Office, Northern District of Illinois, April 21, 2025. While the presence of a dispensing red flag does not prohibit a pharmacist from filling a controlled substance, it means that there is a potential concern with the prescription, which the pharmacist must address andmake a record of its resolution, assuming it is resolvable.

Controlled Substances

Controlled Substances Dosage

The Impact of DEA Telehealth Extensions on Patient Access

PharmExec

DECEMBER 20, 2024

In this part of his Pharmaceutical Executive video interview, Peter Ax, CEO of UpScriptHealth, discusses the recent DEA extensions of telehealth for controlled substances and new treatment modalities or patient populations he anticipates will become more accessible through telehealth in 2025.

Controlled Substances

DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag Resolution

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

23, 2025), DEA reviewed evidence from an administrative hearing and upheld the Administrative Law Judges (ALJs) recommended decision to revoke the registration of a pharmacy that DEA alleged dispensed controlled substances to patients without resolving numerous red flags of diversion. In Neumanns Pharmacy, LLC , 90 Fed.

Controlled Substances

Controlled Substances Documentation

Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules

FDA Law Blog: Biosimilars

DECEMBER 12, 2024

The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III. Last weeks prehearing conference set the parameters for the hearing on the merits, scheduled to begin January 21, 2025. Prehearing Ruling (Dec. 4, 2024), at 1.

Controlled Substances

Controlled Substances Documentation

Competition is on the horizon for costly narcolepsy treatments

pharmaphorum

DECEMBER 14, 2022

Harmony Biosciences introduced Wakix to the market in 2019 as the first non-controlled substance for the treatment of narcolepsy. For Avadel’s Lumryz, the one-dose extended-release oral suspension that allows narcolepsy patients to sleep through the night, the worst-case scenario is it won’t be on the market until 2025.

Controlled Substances

Two “Unresolvable” Prescribing/Dispensing Red Flags Unfurled

FDA Law Blog: Biosimilars

JUNE 3, 2025

Attorneys Office, Northern District of Illinois, April 21, 2025, quoted here. Press Release, Walgreens Agrees To Pay Up to $350M for Illegally Filling Unlawful Opioid Prescriptions and Submitting False Claims, U.S.

Prescription Filling

Prescription Filling Controlled Substances

HPM’s Larry Houck Presenting at WCF Opioid and Fentanyl Abuse Management Congress

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.

Controlled Substances

Controlled Substances Hospitals

HPM’s Larry Houck Speaking at Opioid and Fentanyl Abuse Management Summit

FDA Law Blog: Biosimilars

JULY 7, 2025

The diversion of controlled substances intended for patients by physicians, pharmacists, nurses and other trusted healthcare employees is a significant issue facing hospitals and healthcare facilities.

Controlled Substances

Controlled Substances Hospitals

DOJ Position on Administrative Law Judges

FDA Law Blog: Biosimilars

MARCH 6, 2025

This statement followed a February 20, 2025 letter from Acting Solicitor General Sarah Harris to President Pro Tempore of the Senate Charles Grassley stating the same and noting that the Department will no longer defend the layers of removal restrictions for ALJs in court. Bondi , No. 3:23-cv-2883-E, ECF No.

Controlled Substances

Bring Out Your Meds! To the Feds!

FDA Law Blog: Biosimilars

APRIL 17, 2025

Unwanted and expired controlled prescription medication languishing in medicine cabinets are prime candidates for theft, misuse and abuse. DEA and its law enforcement partners will once again host local drop-off locations nationwide for safe disposal of unneeded medication on Saturday, April 26, 2025, from 10:00 a.m. to 2:00 p.m.

Controlled Substances

Building Intelligent Pharma Supply Chain Management with Real-World Data

Pharmaceutical Commerce

JUNE 17, 2025

This is particularly important for sensitive medications such as controlled substances, which can be at a higher risk for counterfeiting and diversion. Jeff Webber Key Takeaways Real-world data enhances medication safety and supply chain efficiency.

Health and Personal Care Stores

Health and Personal Care Stores Insurance Coverage and Processing Hospitals Drug Pricing

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law Blog: Biosimilars

JUNE 10, 2025

Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals, 90 Fed. 23,711 (June 4, 2025). 23,483 (June 3, 2025). Public comments must be submitted electronically or postmarked on or before July 3, 2025. 21 U.S.C. § 21 U.S.C. §

Controlled Substances

To Combat Medication Errors, Proper Pharmacy Inventory Counts Are Essential

Pharmacy Times

JUNE 5, 2025

1,2 New products are entering the market that could be poised to revolutionize the inventory counting process for pharmacists and health care providers, especially for controlled substances. Accessed Online via StatPearls on June 5, 2025. Released May 20, 2025. Accessed June 5, 2025. National Library of Medicine.

Pharmacy Technician

Pharmacy Technician Packaging Labelling Immunization

It’s a Three-Peat: DEA and HHS Extend Telemedicine Flexibilities Until December 31, 2025

FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. use of buprenorphine) for opioid use disorder, and for Schedule III-V non-narcotic controlled substances unless the patient receives an in-person examination.

Controlled Substances

Stalemate breaks on telehealth prescriptions of stimulants and addiction treatment

STAT

NOVEMBER 15, 2024

During the pandemic, the Drug Enforcement Agency issued temporary rules that allowed providers to prescribe controlled substances like buprenorphine and Adderall without first meeting a patient in person. 1, and have now been extended until the end of 2025. Those rules were set to expire on Jan.

Controlled Substances

Pharmacist Digest

Prescribing Red Flags: Pharmacists Be Wary of What the Doctor Orders

The Impact of DEA Telehealth Extensions on Patient Access

Trending Sources

DEA Pharmacy Decision Highlights Agency’s Thinking on Expert Credibility and Testimony, as well as Red Flag Resolution

Prehearing Ruling Establishes Marijuana Rescheduling Hearing Ground Rules

Competition is on the horizon for costly narcolepsy treatments

Two “Unresolvable” Prescribing/Dispensing Red Flags Unfurled

HPM’s Larry Houck Presenting at WCF Opioid and Fentanyl Abuse Management Congress

HPM’s Larry Houck Speaking at Opioid and Fentanyl Abuse Management Summit

DOJ Position on Administrative Law Judges

Bring Out Your Meds! To the Feds!

Building Intelligent Pharma Supply Chain Management with Real-World Data

DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

To Combat Medication Errors, Proper Pharmacy Inventory Counts Are Essential

It’s a Three-Peat: DEA and HHS Extend Telemedicine Flexibilities Until December 31, 2025

Stalemate breaks on telehealth prescriptions of stimulants and addiction treatment

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