FDA Law Blog: Biosimilars

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.

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Controlled Substances Documentation Communication 52

epicur

NOVEMBER 10, 2022

Have you ever broken or spilled a bottle of a controlled substance? 5 Reminders for Properly Documenting a Spilled or Broken Bottle of a Controlled Substance A spill or breakage does not constitute a loss because the registrant can account for the controlled substance. If so, did you document it?

Controlled Substances 52

Controlled Substances Documentation Compounding Pharmacies Compounding 52

FDA Law Blog: Biosimilars

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.

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Controlled Substances Hospitals 48

FDA Law Blog: Biosimilars

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.

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Controlled Substances Hospitals 44

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.

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Controlled Substances 317

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.

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Controlled Substances 52

FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

All DEA-registered practitioners may continue to prescribe via audio-visual telemedicine encounters schedule II-V controlled substances, and schedule III-narcotic controlled substances that are FDA-approved for opioid use disorder management and treatment. The federal telemedicine flexibilities (i.e.,

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Controlled Substances 52

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.

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Controlled Substances 26

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.

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Controlled Substances Hospitals 49

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.

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Controlled Substances Hospitals 338

STAT

DECEMBER 21, 2022

California authorities are seeking to revoke a license held by a CVS Health mail-order pharmacy unit for violating several state laws that govern shipments of various controlled substances — including prescription painkillers and ADHD medicines — directly to patients.

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Mail-Order Pharmacies Controlled Substances 253

STAT

DECEMBER 2, 2022

as a way to expand access for therapeutic purposes to potentially beneficial but highly regulated Schedule I substances like psilocybin and LSD, has the right underlying idea but provides a solution that is wrong. The Breakthrough Therapies Act , recently proposed by Senators Rand Paul (R-Ky.) and Cory Booker (D-N.J.)

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Controlled Substances Drug Development 348

STAT

MAY 3, 2023

The DEA announced Wednesday that it was temporarily extending its Covid-era emergency telehealth policies, allowing doctors continued leniency in how they prescribe some controlled substances. Read the rest…

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Controlled Substances 253

FDA Law Blog: Biosimilars

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.

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Controlled Substances Hospitals Medication Dispensing 57

Pharmacy Times

SEPTEMBER 14, 2023

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

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Controlled Substances 66

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.

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Controlled Substances 97

Pharmacy Times

SEPTEMBER 22, 2022

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

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Controlled Substances 52

STAT

SEPTEMBER 6, 2022

Telehealth prescription company Cerebral, which used pandemic-era regulatory flexibility to virtually treat mental health conditions like ADHD, has largely halted controlled substance prescriptions in light of scrutiny from federal and state regulators.

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Controlled Substances 253

Pharmacy Times

OCTOBER 12, 2022

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

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Controlled Substances 49

FDA Law Blog: Biosimilars

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 57

FDA Law Blog: Biosimilars

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.

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Controlled Substances Dosage Documentation 52

FDA Law Blog: Biosimilars

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.

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Controlled Substances 57

FDA Law Blog: Biosimilars

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 103

FDA Law Blog: Biosimilars

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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Controlled Substances Long-Term Care Facilities Dosage Communication 98

FDA Law Blog: Biosimilars

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

FDA Law Blog: Biosimilars

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 51

FDA Law Blog: Biosimilars

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 57

Pharmacy Times

SEPTEMBER 28, 2022

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

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Controlled Substances 26

FDA Law Blog: Biosimilars

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 57

FDA Law Blog: Biosimilars

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 57

FDA Law Blog: Biosimilars

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 113

FDA Law Blog: Biosimilars

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. at 30,039 (emphasis added).

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Controlled Substances Communication 52

Pharmacy Times

JANUARY 18, 2024

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

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Controlled Substances 55

FDA Law Blog: Biosimilars

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

FDA Law Blog: Biosimilars

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

Pharma Leaders

APRIL 11, 2023

Currently, the class is listed as Schedule IV under the Controlled Substances Act, which includes habit-forming drugs such as Valium and Xanax. Idorsia Pharmaceuticals has petitioned the Drug Enforcement Administration (DEA) to deschedule dual orexin receptor antagonists (DORA), a class of chronic insomnia medications.

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Controlled Substances 52

NY Times

JUNE 27, 2022

In a unanimous ruling, the justices ordered federal appeals courts to reconsider the cases of two doctors convicted of violating the Controlled Substances Act.

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Controlled Substances 64