The FDA Law Blog

JULY 31, 2023

CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72 hours for emergency oral prescriptions).

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The FDA Law Blog

OCTOBER 9, 2022

We also note there are states where marijuana remains the equivalent of a schedule I controlled substance. Separate and apart from the loosening of marijuana restrictions by these states, marijuana remains a schedule I controlled substance under federal law.

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Controlled Substances 105

The FDA Law Blog

AUGUST 26, 2024

Interested persons,” that is “any person adversely affected or aggrieved by any rule or proposed rule issuable” under the Controlled Substances Act wishing to participate in the hearing must file a written notice of their intention to participate, which DEA will review.

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Controlled Substances 104

The FDA Law Blog

APRIL 22, 2025

An Immediate Suspension Order is served along with an Order to Show Cause, allowing you to challenge DEAs determination that your registration should be revoked, but it takes away your ability to handle controlled substances while your case is pending.

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The FDA Law Blog

NOVEMBER 10, 2022

Attorney’s press release observes, it is a stark reminder that registrants are “ultimately responsible for supervising all personnel on the premises and preventing the diversion of controlled substances.” Company Pays $158,760 to Resolve Claims Related to Controlled Substance Thefts From Pharmacies During Inventory, U.S.

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Controlled Substances 59

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.” The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. By Larry K. 21 U.S.C. §

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The FDA Law Blog

AUGUST 8, 2024

Comments ranged from single sentence declarations to lengthy, cogent treatises, expounding on whether to reschedule marijuana from schedule I to schedule III or another schedule under the federal Controlled Substances Act (“CSA”), to leave marijuana in schedule I, or to deschedule altogether. 21 U.S.C. § 812(c)(c)(10). 21 U.S.C. §

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Controlled Substances Dosage FDA 59

The FDA Law Blog

MARCH 30, 2023

Houck — Perhaps you obtain controlled substance quotas or submit ARCOS reports? DEA’s Diversion Control Division is hosting a Supply Chain Conference for registered manufacturers, distributors, importers and exporters on controlled substance and listed chemical requirements in Houston on May 2-4, 2023. By Larry K.

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Controlled Substances 59

Omnicell

JANUARY 12, 2023

And if a hospital is still relying on outdated processes for medication retrieval, controlled substance management, and compliance, conditions for burnout are exacerbated. Disclaimer The views and opinions expressed in this blog are those of the authors. For many nurses, direct patient care is at the heart of meaningful work.

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Omnicell Controlled Substances Hospitals Patient Care 84

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.

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Controlled Substances 64

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. part 1306 (which include DEA’s general requirements for prescribing controlled substances); 88 Fed. By Karla L. 1307.41and 42 C.F.R.

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Controlled Substances Communication 52

The FDA Law Blog

MAY 7, 2023

As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing controlled substances generally, and for buprenorphine use in opioid treatment. HPM also conducted a 90-minute webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.”

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Controlled Substances 52

Omnicell

JANUARY 10, 2023

The Omnicell Blog is the leading source for pharmacy care, exploring emerging trends, successful best practices, and ideas and insights focused on the digital transformation of pharmacy. Subscribe today. Assumptions made in the analysis are not reflective of the position of any entity other than the author(s).

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Omnicell Patient Care Controlled Substances Hospitals 95

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.

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Controlled Substances 59

The FDA Law Blog

MAY 31, 2023

On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlled substances. While this decision was pending, Morris & Dickson remained an authorized DEA registrant to continue to handle controlled substances.

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Controlled Substances 59

The FDA Law Blog

MAY 3, 2023

Accounting for controlled substances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection. Registrants are far from powerless when DEA investigators inspect their controlled substance operations.

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Controlled Substances 52

The FDA Law Blog

MARCH 12, 2023

We will discuss the state of relevant laws prior to our new “COVID reality” and telemedicine issues during and post-pandemic, both with respect to the prescribing of controlled substances and non-controlled drugs.

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Controlled Substances FDA 98

Omnicell

JANUARY 10, 2023

Kim Dove, PharmD Senior Pharmacy Consultant, Omnicell We all understand the harm that controlled substance drug diversion can cause to patients, the healthcare institution, and of course, to the diverters themselves. Consider your practices for entering new medication shipments into inventory.

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Controlled Substances Hospitals Medication Dispensing Omnicell 52

The FDA Law Blog

APRIL 18, 2023

Houck — In addition to regulating drugs of abuse, the federal Controlled Substances Act (“CSA”) controls the manufacture and distribution of chemicals used in the illicit manufacture of controlled substances. By Larry K.

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Controlled Substances 59

Omnicell

JANUARY 10, 2023

Yet in operating rooms and procedure areas – where a large quantity of tightly regulated controlled substances are administered – similar technology is used by just over half of health systems. Ideally pharmacy and anesthesia providers should work in partnership to maintain controlled substance accountability.

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Controlled Substances Omnicell Medication Dispensing Documentation 52

Omnicell

JANUARY 10, 2023

Given the number of high-alert controlled substances administered under often intense conditions inside the operating room (OR), it's no surprise. The pharmacy must also make sure that all controlled substances distributed are properly recorded. Information flow wasn't seamless, and they had a lot of manual workflows.

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Controlled Substances Omnicell Medication Dispensing Hospitals 52

Omnicell

JANUARY 10, 2023

Expanded Automation With more than 148 million doses of medicine lost in 2019 , controlled substance management remains a significant challenge in the U.S. The Controlled Substance Dispenser helps to better manage inventory, reduce the chance of diversion, and save nursing time.

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Controlled Substances Omnicell Compounding Sterile Compounds 52

The FDA Law Blog

FEBRUARY 19, 2023

Mr. Houck’s session will address pharmacists’ corresponding responsibility to identify and resolve controlled substance prescribing red flags and how to prepare for and manage DEA inspections. The session will occur Friday, March 24th. Pharmacists can earn 1 continuing practice education credit for attending this session.

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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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Controlled Substances General Merchandise Stores Grocery Stores Compounding 52

The FDA Law Blog

MAY 22, 2023

Accounting for controlled substances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection. Registrants are far from powerless when DEA investigators inspect their controlled substance operations.

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Controlled Substances 40

The FDA Law Blog

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. By Larry K. 21 U.S.C. §

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Controlled Substances FDA 59

The FDA Law Blog

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III.

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Controlled Substances FDA 64

The FDA Law Blog

APRIL 22, 2024

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. The Senators implore efforts to reschedule marijuana be driven by facts, “not the administration’s favored policy,” and question whether rescheduling would violate the Controlled Substances Act (“CSA”) and U.S.

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Controlled Substances FDA 59

Omnicell

SEPTEMBER 5, 2022

Nish also shared how development roadmaps are being shaped to optimize management of medication floor stock inventory and controlled substances, to improve pharmacy, nursing and anesthesiology workflows. Assumptions made in the analysis are not reflective of the position of any entity other than the author(s).

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Omnicell Hospitals Controlled Substances 52

Omnicell

JANUARY 10, 2023

At TidalHealth, we're partnering with our nursing and anesthesia colleagues to drive diversion awareness and controlled substance monitoring. The Omnicell Blog is the leading source for pharmacy care, exploring emerging trends, successful best practices, and ideas and insights focused on the digital transformation of pharmacy.

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Omnicell Medication Dispensing CPhT Documentation 52

Omnicell

JANUARY 10, 2023

At the same time, Pharmacy needs to maintain accountability for the controlled substances being dispensed. DISCLAIMER The views and opinions expressed in this blog are those of the authors and do not necessarily reflect the official policy or position of any other agency, organization, employer or company.

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Controlled Substances Omnicell Patient Care Hospitals 52

Omnicell

JANUARY 10, 2023

A manual medication workflow can lead to possible safety gaps, especially in an OR where there's no guarantee that every controlled substance will be at your disposal in an organized fashion should something go wrong and when the unexpected arises during surgeries and procedures.

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Controlled Substances Omnicell Medication Dispensing Documentation 52

The FDA Law Blog

JANUARY 11, 2024

Given the significant growth and development opportunities available in Puerto Rico, Karla and Dara will discuss the FDA’s prescription drug approval process, and more importantly the “exportation” of prescription pharmaceuticals — including controlled substances — from Puerto Rico into the United States.

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Controlled Substances 59

Omnicell

JANUARY 10, 2023

For example, automating controlled substance administration protects nurses and patients alike. The Omnicell Blog is the leading source for pharmacy care, exploring emerging trends, successful best practices, and ideas and insights focused on the digital transformation of pharmacy. Subscribe today.

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Omnicell Medication Delivery Hospitals Controlled Substances 52

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. The DEA Administrator issued a General Notice of Hearing fixing December 2nd as the commencement date for the hearing.

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Controlled Substances Documentation 52

The FDA Law Blog

FEBRUARY 5, 2024

Some of the services HP&M offers include: comprehensive regulatory assessments pre-launch licensing support license gap analysis support for new product/company acquisitions, regulatory diligences DEA registrations and state-controlled substance licenses With the complexities of licensure, Sara M. Palmer , Larry K.

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The FDA Law Blog

JANUARY 24, 2024

FDA Law Blog is a conference media partner. This in-depth training will include practical real-world examples that will help you to excel in your everyday practices. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks! As such, we can offer our readers a special 10% discount.

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