The FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. 6, 2023 ( DOJ Press Release ). Zarzamora Press Release.

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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

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

FEBRUARY 7, 2024

Gilbert — Last week, DEA and DOJ announced a $59 million civil penalty settlement with eBay related to the failure to comply with Controlled Substances Act (CSA) requirements for identifying purchasers, maintaining records, and filing reports of individuals selling/purchasing pill presses and encapsulating machines. 21 U.S.C. §

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Controlled Substances Documentation 116

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

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 26, 2023

Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. 21 U.S.C. §

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Controlled Substances 53

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

Omnicell

SEPTEMBER 5, 2022

One area where interoperability specifically helps is the management of controlled substances. When it comes to managing diversion, interoperability supports a tightened chain of custody across the controlled substance journey. That’s time gained to now spend on direct patient care.

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Controlled Substances Omnicell Patient Care Hospitals 98

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 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

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

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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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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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 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

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

Board Vitals - Pharmacist

JANUARY 9, 2021

Alabama – 2 Credits The Alabama State Board of Medical Examiners requires 2 credit hours every 2 years on controlled substances for physicians. Stay tuned, we’ll update this blog and our Opioid CME offerings as we get more information on new state requirements. Colorado No opioid CME requirements.

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Controlled Substances 52

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

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

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

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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Controlled Substances Documentation Communication 45

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 Controlled Substances Patient Care Hospitals 95

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

Digital Pharmacist

AUGUST 12, 2022

In today’s blog, we’re going to provide you with a few tips. . Pharmacies should prepare for higher volumes of controlled substance prescriptions used to treat ADHD like amphetamine salts, dextroamphetamine, lisdexamfetamine, methylphenidate, and dexmethylphenidate.

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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

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

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

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 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 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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FDA Controlled Substances 59

The FDA Law Blog

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. “While our attorneys don’t do this work for the recognition, it is gratifying to see their excellent work recognized.

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Controlled Substances FDA 40

The FDA Law Blog

AUGUST 4, 2023

Houck — Anabolic steroids that include testosterone, methyltestosterone, nandrolone decanoate and oxandrolone are schedule III controlled substances with currently accepted medical uses in the U.S. By Larry K. Other anabolic steroids are approved only for use in veterinary medicine.

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The FDA Law Blog

MARCH 27, 2023

As promised during the 90-minute program, we provide our slides here, and a recording of the program, here (passcode. Our attorneys are happy to respond to questions you may have, and look forward to hearing from you.

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Controlled Substances 40

Omnicell

SEPTEMBER 5, 2022

.” This CE-accredited session for pharmacy and nursing discussed how COVID-19 is compounding complications of Substance Use Disorder, and shared best practices for diversion monitoring in order to refocus resources and revise schedules amidst COVID-19.

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Omnicell Controlled Substances Hospitals Documentation 52

The FDA Law Blog

MARCH 9, 2023

Attorney’s Offices, and, importantly for readers of this blog, the Civil Division’s Consumer Protection Branch (CPB), will all consistently reward corporations that voluntarily disclose and remediate misconduct. That means that the Criminal Division, 94 U.S. Attorney’s Offices around the country.

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FDA Controlled Substances Documentation 52