The FDA Law Blog

MAY 16, 2024

Houck — Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). DEA alleged that UMHS failed to maintain complete and accurate records and failed to timely notify DEA of controlled substance thefts.

Controlled Substances 59

Controlled Substances Hospitals Intravenous Solutions 59

OctariusRx

FEBRUARY 20, 2023

The 2023 controlled substance assessment quiz is about to be released! This is our first 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 79

Controlled Substances Documentation Compounding 79

Drug Topics

JULY 24, 2023

Filling a prescription for a controlled substance requires more oversight than the average prescription.

Controlled Substances 98

Controlled Substances 98

Pharmacy Times

APRIL 28, 2023

Proposed rules would permit a telehealth provider to prescribe only up to a 30-day supply of a Schedule III-V non-narcotic controlled substance or buprenorphine through telehealth without the patient first being evaluated in person by a provider.

Controlled Substances 132

Controlled Substances 132

Pharmacy Times

DECEMBER 22, 2023

Controlled substance transfers are occurring at a higher rate as health systems create their own ecosystems to combat medication shortages.

Controlled Substances 65

Controlled Substances 65

Pharmacy Times

DECEMBER 21, 2022

A controlled substances diversion prevention program (CSDPP) that aligns with the revised ASHP guidelines is critical to ensure patients are protected from occurrences of drug diversion.

Controlled Substances 123

Controlled Substances Hospitals 123

OctariusRx

JULY 20, 2023

The DEA is changing the process for reporting loss of controlled substances. Effective July 24, 2023, the process for reporting lost controlled substances will be fully electronic. The post The DEA is changing the process for reporting loss of controlled substances appeared first on OctariusRX.

Controlled Substances 64

Controlled Substances 64

indispensable health

SEPTEMBER 7, 2021

DEA Regulations For Controlled Substances Within Healthcare Settings The U.S. to complete a biennial controlled substance inventory. to complete a biennial controlled substance inventory. The Pharmacist-In-Charge, Or Designee, Is Responsible For Completing An Inventory On Hand For ALL Controlled Substances.

Controlled Substances 52

Controlled Substances Long-Term Care Facilities Dosage 52

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 58

Controlled Substances Compounding 58

Drug Topics

AUGUST 17, 2023

Each year, drug diversion is estimated to cost the US health care system an estimated $70 billion. Outside of these costs, drug diversion poses a significant risk to patient safety and patient’s communities.

Controlled Substances 98

Controlled Substances 98

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 52

Controlled Substances Documentation Communication 52

Pharmacy Times

SEPTEMBER 14, 2023

AI is able to quickly analyze, identify, and route data for investigation.

Controlled Substances 167

Controlled Substances 167

STAT

NOVEMBER 11, 2022

Health tech companies that have taken advantage of the possibility to prescribe controlled substances online during the pandemic may soon find their businesses — and their ability to care for patients — in jeopardy. 

Controlled Substances 96

Controlled Substances Labelling 96

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 52

Controlled Substances Omnicell Hospitals 52

Drug Topics

MARCH 24, 2024

At this year’s American Pharmacists Association Annual Meeting & Exposition, Mark Garofoli urged pharmacists to develop strong documentation practices and go beyond baseline federal regulations to care for patients with red flags.

Controlled Substances 112

Controlled Substances Documentation 112

The FDA Law Blog

SEPTEMBER 12, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

Controlled Substances 49

Controlled Substances Hospitals 49

Pharmacy Times

SEPTEMBER 22, 2022

Eliminating paper prescriptions allows for greater legibility, security, trackability for pharmacists, providers.

Controlled Substances 132

Controlled Substances 132

The FDA Law Blog

SEPTEMBER 26, 2023

More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.

Controlled Substances 45

Controlled Substances Hospitals 45

Pharmacy Times

OCTOBER 12, 2022

Eliminating paper prescriptions allows for greater legibility, security, trackability for pharmacists and providers.

Controlled Substances 122

Controlled Substances 122

Fierce Healthcare

JULY 1, 2024

OptumRx will pay $20 million to resolve claims the company violated the Controlled Substances Act by improperly filling certain opioid prescriptions, the Department of Justice recently announced.

Controlled Substances 124

Controlled Substances 124

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 59

Controlled Substances FDA Documentation Labelling 59

Pharmacy Times

SEPTEMBER 28, 2022

Lawsuit asserts physician, pharmacist negligence in patient’s fatal overdose after she received alprazolam, oxycodone, oxymorphone.

Controlled Substances 65

Controlled Substances 65

STAT

JANUARY 17, 2023

Catherine was getting nervous about her ADHD prescription. In 2022, the 29-year-old New Yorker had started using Done, a direct-to-consumer telehealth company that treats attention deficit hyperactivity disorder.

Controlled Substances 110

Controlled Substances 110

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. DOJ, Iowa Surgical Center Agrees to Pay $125,000 to Resolve Allegations It Violated the Controlled Substances Act ( June 4, 2024 ). By Larry K.

Controlled Substances 59

Controlled Substances Hospitals Medication Dispensing 59

Pharmacy Times

JANUARY 18, 2024

Because medications to treat these conditions are often controlled substances, including pharmacists on the multidisciplinary team (MDT) is invaluable.

Controlled Substances 139

Controlled Substances 139

Fierce Healthcare

JUNE 14, 2024

| The Drug Enforcement Administration has submitted a proposed telehealth prescribing rule to the Office of Management and Budget which aims to regulate how telehealth providers prescribe controlled substances when the patient and provider do not have an established relationship.

Controlled Substances 124

Controlled Substances 124

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. 72,694, 72,703 (Dec.

Controlled Substances 52

Controlled Substances Insurance Dosage Documentation 52

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 139

Controlled Substances Documentation Dosage Prescription Filling 139

The Checkup by Singlecare

FEBRUARY 9, 2023

The law states that a pharmacist must only fill a prescription for a controlled substance when it is issued for a legit medical reason by a legitimate practitioner acting within the usual scope of their professional practice. The DEA defines a controlled substance as a drug or chemical known to be addictive or habit-forming.

Controlled Substances 96

Controlled Substances Insurance Coverage Insurance Labelling 96

STAT

JUNE 13, 2024

They were charged with allegedly taking part in a scheme to distribute controlled substances online and submitting false and fraudulent reimbursement claims for stimulant prescriptions. Done founder Ruthia He, and clinical president David Brody, were arrested in Los Angeles and San Rafael, California respectively.

Controlled Substances 128

Controlled Substances 128

Pharmaceutical Technology

MARCH 13, 2024

Bright Green has announced plans to expand its controlled substances drug production facility in New Mexico, US with an investment of $250m.

Controlled Substances 97

Controlled Substances 97

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 133

Controlled Substances 133

The FDA Law Blog

OCTOBER 30, 2023

Houck — The Drug Enforcement Administration (“DEA”) has issued its notice finalizing updates to its longstanding Special Surveillance List of chemicals and equipment used in the illicit manufacture of controlled substances and listed chemicals. 73,044 (Oct. DEA’s notice of updates with the Special Surveillance List is attached here.

Controlled Substances 59

Controlled Substances 59

STAT

MAY 1, 2024

The DEA dictates the quantity of controlled substances that drug companies are allowed to make. WASHINGTON  — The Drug Enforcement Administration is reversing a regulation that had been expected to create shortages of morphine and other opioid injectables, according to a DEA letter to drugmakers obtained by STAT.

Controlled Substances 130

Controlled Substances Hospitals 130

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 98

Controlled Substances Long-Term Care Facilities Dosage Communication 98

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 59

Controlled Substances 59

OctariusRx

JUNE 26, 2023

What would your facility do without a controlled substance license? As we all know, diversion of controlled substances has been on the rise. As we all know, diversion of controlled substances has been on the rise. We are in the business of making sure our patients are always safe when in our care.

Controlled Substances 76

Controlled Substances 76