OctariusRx

OCTOBER 28, 2024

Speaking at the “2024 Northeast ASC Conference” is always a great time. My presentation focused on current topics in medication management, including patient safety, safe injection practices and controlled substances. A special thank you to MAASC President, Greg DeConciliis for the invitation to participate.

Controlled Substances

Drug Topics

OCTOBER 26, 2024

The Drug Enforcement Administration gives controlled substance licenses, and can just as easily take them away.

Controlled Substances

The FDA Law Blog

MARCH 6, 2025

109 (2024), the Supreme Court upheld a decision by the U.S. (For an in-depth review of the history of ALJs and the removal protections enacted by the APA, see Brief of Amicus Curiae Federal Administrative Law Judges Conference 8-20, SEC v. Jarkesy , No. 22-859 (Sept. The constitutionality of ALJs has been a hot legal topic of late.

Controlled Substances

Drug Topics

NOVEMBER 8, 2024

Joel Ferre, JD, Assistant United States Attorney in Utah, led a discussion covering the DEA and pharmacies’ roles in reporting red flags when dispensing medication.

Controlled Substances

OctariusRx

FEBRUARY 20, 2024

The 2024 controlled substance assessment quiz is about to be released! This is our annual competency assessment focused on controlled substances and regulatory compliance. The quiz focuses on some of the basic elements managing controlled substances. How are you assessing your staff?

Controlled Substances

Fierce Healthcare

OCTOBER 6, 2023

The Drug Enforcement Administration (DEA) said Friday it will extend telehealth flexibilities that enable clinicians to virtually prescribe controlled medications to their patients through 2024 as | The DEA announced Friday that it is extending pandemic rules for prescribing controlled substances via telemedicine through the end of next year.

Controlled Substances

STAT

OCTOBER 2, 2024

urged the DEA to continue allowing health providers to prescribe buprenorphine, a controlled substance used to treat opioid addiction, without requiring an in-person visit.    Prior to the Covid-19 pandemic, any patient who needed a controlled substance was required to be examined in person before receiving a prescription.

Controlled Substances

OctariusRx

AUGUST 19, 2024

The 2024 version of the OctariusRx medication safety quiz is about to be released. The quiz focuses on some of the most commonly encountered situations, including allergies, labeling medications and controlled substances. The post Medication Safety Quiz 2024 appeared first on OctariusRX. How are you assessing your staff?

Controlled Substances

The FDA Law Blog

AUGUST 26, 2024

The Drug Enforcement Administration (“DEA”) will announce Thursday in the Federal Register that it will hold a hearing on the proposed rescheduling of marijuana to schedule III at DEA Headquarters in Arlington, Virginia on December 2, 2024.

Controlled Substances

Omnicell

SEPTEMBER 5, 2022

billion is forecasted to be spent on electronic health records (EHR) by 2024, many hospitals continue to be burdened with costs. One area where interoperability specifically helps is the management of controlled substances. Disconnected systems also complicate merger and acquisition activity. Although $9.9

Controlled Substances

The FDA Law Blog

OCTOBER 8, 2023

Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. 69,879, 69,880 (Oct. 10, 2023) (emphasis added).

Controlled Substances

The FDA Law Blog

JUNE 10, 2024

Last month the Department of Justice and the Drug Enforcement Administration submitted a notice of proposed rulemaking to reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Hyman, Phelps & McNamara, P.C.

Controlled Substances

The FDA Law Blog

JANUARY 11, 2024

HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C.

Controlled Substances

The FDA Law Blog

MAY 10, 2023

Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. effective May 12, 2023 through November 11, 2024, Telemedicine relationships that are included in this period must be “in effect” as of November 11, 2023. By Karla L.

Controlled Substances

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.” 50,372 , 50,377 (June 13, 2024). Last December we blogged on the $275,000 civil penalty imposed by the U.S. 72,694, 72,703 (Dec. 21 U.S.C. §

Controlled Substances

The FDA Law Blog

DECEMBER 12, 2024

The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III. 4, 2024), at 1. The DEA Administrator issued a General Notice of Hearing fixing December 2nd as the commencement date for the hearing. Prehearing Ruling (Dec.

Controlled Substances

The FDA Law Blog

APRIL 22, 2024

Milgram’s predecessors, and Directors of National Drug Policy urging not to reschedule; the January 2004 letter Democratic state attorneys general pushing for rescheduling to schedule III; and the January 2024 letter from Democratic senators requesting descheduling altogether. The senators write that the U.S.

Controlled Substances

The Checkup by Singlecare

AUGUST 15, 2024

Aetna’s Standard Control Plan and a Human Medicare plan are examples of ones not covering the drug in 2024. Consider a cheaper weight-loss drug Generic phentermine costs $5 for a one-month supply, but it is a controlled substance and is only approved for up to six months of use. Is Contrave covered by insurance?

Insurance

The FDA Law Blog

JULY 1, 2024

Karst — The Drug Enforcement Administration (“DEA”) has received more than 2 7 ,000 public comments in response to its May 21, 2024 , Notice of Proposed Rulemaking (“ NPRM ”) to reschedule marijuana from schedule I to schedule III. Letter to DEA Administrator Anne Milgram, from Peter Bensinger, et al., ( June 19, 2024 ).

Dosage

The FDA Law Blog

APRIL 17, 2024

DEA, with its law enforcement partners, will host thousands of local drop-off locations nationwide for clearing out and proper disposal of unwanted expired and unneeded medication from medicine cabinets between 10:00 am to 2:00 pm local time on Saturday, April 27, 2024. Events over the years have led to the removal of more than 17.9

Controlled Substances

The FDA Law Blog

JANUARY 24, 2024

The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York.

FDA

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. § 112-029 ), titled “Calculation of 60-Day Period for Application of Patent Term Extension” and referred to by some as “The Dog Ate My Homework Act” or the “Medco Fix.” Patent Nos.

Labelling

The Checkup by Singlecare

APRIL 2, 2024

RELATED: Overweight and obesity statistics 2024 Where can I get phentermine? Since phentermine is a controlled substance, you need to be cautious and ensure that you are purchasing from a reputable and licensed online pharmacy if you have to.” Where can I get phentermine pills?

Controlled Substances

The FDA Law Blog

FEBRUARY 27, 2024

On February 8, 2024—the same day the PTO requested information with respect to the multiple PTE applications for idelalisib—the FDA sent a letter to the PTO in response to the PTE applications for for U.S. Karst — It’s been a while since we last blogged on Patent Term Extension (“PTE”) issues of interest. Patent Nos. 7,214,695 and 7,214,696.

FDA

The Checkup by Singlecare

JULY 3, 2024

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?

Controlled Substances

The FDA Law Blog

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. Employee diversion can result in unwanted local and national publicity.

Controlled Substances

The Checkup by Singlecare

MARCH 1, 2024

But determining whether someone needs it is challenging, and because it’s a controlled substance, getting a prescription can be, too. The Drug Enforcement Administration (DEA) classifies Adderall as a Schedule II controlled substance , which means it has a high potential for abuse and psychological or physical dependence.

Controlled Substances

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. treaty obligations in rescheduling. 21 U.S.C. § 812(b)(1).

Controlled Substances

The FDA Law Blog

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.

FDA

The FDA Law Blog

DECEMBER 21, 2023

Director Larry Houck will present a webinar on HHS’ cannabis rescheduling recommendation hosted by the National Association of State Controlled Substance Authorities (“NASCSA”) scheduled for Tuesday, January 9, 2024 at 3:00 pm (Eastern). Hyman, Phelps & McNamara, P.C.,

Controlled Substances

The FDA Law Blog

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

FDA

The Checkup by Singlecare

MAY 5, 2024

The FDA’s drug shortage database cites all generic manufacturers of lisdexamfetamine as having limited to no product availability as of April 2024. For these reasons, Vyvanse is considered a controlled substance by the Drug Enforcement Administration (DEA). It can be frustrating not to be able to get your prescribed medicine.

Labelling

The FDA Law Blog

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. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). By Larry K.

Controlled Substances

The FDA Law Blog

FEBRUARY 11, 2024

Letter 3: Top Ten Reasons for Descheduling Cannabis Altogether From: Democratic Senators Date: January 29, 2024 Twelve Democratic senators signed Letter 3. January 29, 2024). Letter to DEA Administrator Anne Milgram, from Phil Weiser, et al., (Jan.

Controlled Substances

The FDA Law Blog

APRIL 29, 2024

Houck — On April 23, 2024 we blogged about Republican Senators Mitt Romney, Pete Ricketts and James Risch advising Drug Enforcement Administration (“DEA”) Administrator Anne Milgram to consider U.S. April 24, 2024. Vice president criticizes federal cannabis restrictions during White House weed event , March 15, 2024.)

Controlled Substances

Fierce Healthcare

NOVEMBER 18, 2024

DEA finalizes one-year extension of controlled substance prescribing via telehealth, punts final regs to incoming Trump admin ebeavins Mon, 11/18/2024 - 10:50

Controlled Substances

The FDA Law Blog

NOVEMBER 26, 2024

Houck — Last May the Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to transfer marijuana from schedule I of the Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed.

Controlled Substances