The FDA Law Blog

MARCH 24, 2025

Department of Health and Human Services (HHS), based on the federal Controlled Substances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K.

Controlled Substances

The FDA Law Blog

MAY 4, 2025

(IMC Pro), a shipping and logistics company based in North Carolina, agreed to pay $400,000, not a significant amount compared to some recent settlements, but not chump change either, to resolve allegations that it violated the Controlled Substances Act for transshipping precursor chemicals. of 1-BOC-Piperidone and 138.66

Controlled Substances

The FDA Law Blog

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

The FDA Law Blog

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.

Controlled Substances

The FDA Law Blog

MARCH 6, 2025

By Andrew J. Hull Late last month, the Department of Justice filed a short statement regarding administrative law judges (ALJs).

Controlled Substances

The FDA Law Blog

APRIL 11, 2025

Hull Last month, we blogged on the Department of Justices (DOJ) abrupt announcement that it had determined that removal restrictions protecting administrative law judges (ALJs) were unconstitutional and that DOJ would no longer defend those removal restrictions in court. By Andrew J.

Controlled Substances

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.

Controlled Substances

The FDA Law Blog

FEBRUARY 28, 2023

Houck — The Drug Enforcement Administration’s (“DEA’s”) February 13th determination that THC acetate ester (“THCO”) is a schedule I controlled substance under the federal Controlled Substances Act (“CSA”) has received a good amount of attention in the cannabis press. By Larry K. 51639, 51641 (Aug.

Controlled Substances

Omnicell

SEPTEMBER 5, 2022

The opioid crisis is not just a national issue, it’s also one of healthcare’s biggest challenges, making the security and accountability of controlled substances a priority for healthcare institutions. Adopting technology solutions to support controlled substance management.

Controlled Substances

The FDA Law Blog

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. By Larry K.

Controlled Substances

Omnicell

JANUARY 10, 2023

Tara Plappert Product Marketing Manager Hospitals and clinics face a significant challenge when dealing with controlled substances. The Controlled Substance Dispenser dispenses one dose at a time, ensuring security, and minimizing the need for nurse countbacks. And according to the 2019 Drug Diversion Digest , 47.2

Controlled Substances

The FDA Law Blog

FEBRUARY 27, 2023

Palmer — The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. DEA’s proposed rule when finalized would authorize telemedicine pursuant to the Controlled Substances Act, 21 U.S.C. § By Karla L.

Controlled Substances

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.

Controlled Substances

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).

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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.

Omnicell

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. §

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

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.

Controlled Substances

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).

Omnicell

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.

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

Controlled Substances

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.”

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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.

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

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.

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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.

Controlled Substances

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 ).

Controlled Substances

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.

Controlled Substances