FDA Law Blog: Biosimilars

APRIL 22, 2025

Both the government (represented by DEA counsel) and you will have an opportunity to present your case through witness testimony and record evidence. The hearing closely resembles a trial, but the ALJ (rather than a jury) is the trier of fact. Hearings can range from half a day to several weeks, depending on the complexity of the case.

Controlled Substances 52

Controlled Substances Documentation 52

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.” Last December we blogged on the $275,000 civil penalty imposed by the U.S. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec.

Controlled Substances 52

Controlled Substances Dosage Documentation 52

FDA Law Blog: Biosimilars

DECEMBER 12, 2024

The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III. Judge Mulrooneys prehearing ruling establishes the schedule for the parties presentations and established hearing guidelines. Parties will have ninety minutes to present the testimony of their witness.

Controlled Substances 52

Controlled Substances Documentation 52

FDA Law Blog: Biosimilars

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

Pharmaceutical Technology

DECEMBER 5, 2022

However, at the federal level, cannabinoids remain illegal under the Controlled Substances Act. In Asia, Africa and the Middle East, cannabinoid-based drugs are mostly illegal and continue to present a major regulatory obstacle. However, access is restricted, requiring a special permit given under exceptional circumstances.

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Controlled Substances Compounding Immunity Immunization 98

FDA Law Blog: Biosimilars

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 59

FDA Law Blog: Biosimilars

JANUARY 11, 2024

HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C.

Controlled Substances 59

Controlled Substances 59

FDA Law Blog: Biosimilars

JUNE 3, 2025

DEAs position is contrary to statements made in the agencys 2024 Coconut Grove decision when its expert opined at the hearing that filling immediate-release opioids prescribed and dispensed over a period of one and a half to two years presented red flags and [the pharmacy] needed to properly resolve these red flags before dispensing.

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Prescription Filling Controlled Substances 59

Med Ed 101

MAY 10, 2017

When giving a presentation the other day, I received a question about how to handle gabapentin abuse. It is a tough question, much like opioid, benzo, stimulant, or any other controlled substance. The post How to Handle Gabapentin Abuse appeared first on Med Ed 101.

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Controlled Substances 40

Pharmaceutical Business Review

SEPTEMBER 1, 2023

Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) intended for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications. These capsules are presently on the FDA’s drug shortage list. The generic version by SpecGx is produced at its facility in Hobart, New York.

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Controlled Substances 52

Board Vitals - Pharmacist

SEPTEMBER 3, 2022

As of November 2022, NPs have the authority to prescribe medications, including controlled substances, medical devices, and services, medical equipment and supplies in 26 states. You may submit the educational presentation or conference agenda as evidence to validate the contact hour calculation.

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Controlled Substances 52

Pharma in Brief

JANUARY 7, 2024

Biologics, controlled substances, and certain other drugs are not eligible for importation. Prescription drugs, biologics, controlled substances, and certain other drugs (FDR section C.01.014.8).

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Controlled Substances Labelling 52

FDA Law Blog: Biosimilars

AUGUST 16, 2023

And before CooperSurgical, another 2021 Warning Letter was issued to AcelRx for the infamous “Tongue and Done” tagline used to promote a Schedule II controlled substance subject to a REMS program that requires a healthcare professional’s precise placement of the drug using a single-dose applicator into the patient’s sublingual space.

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Labelling Controlled Substances Communication 52

FDA Law Blog: Biosimilars

APRIL 21, 2024

Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § 112-029 ), titled “Calculation of 60-Day Period for Application of Patent Term Extension” and referred to by some as “The Dog Ate My Homework Act” or the “Medco Fix.”

Labelling 59

Labelling Controlled Substances 59

Pharmaceutical Technology

JUNE 14, 2023

According to GlobalData’s Drugs database, 97% of marketed drugs are small molecule products and analysis shows an increased CMO appetite for specialized capabilities, with controlled substance and containment facilities highly sought after [i]. This is achieved via a controlled vacuum.

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Controlled Substances Communication 52

The Nontraditional Pharmacist

AUGUST 19, 2019

So currently I work as one of the project managers and QA engineers for Kit Check, where I primarily work on Bluesight for controlled substances and I’ll go definitely go down exactly what that is. So it’s really cool to have someone like him in a pharmacy software setting.

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Controlled Substances Hospitals Pharmacy Technician 52

FDA Law Blog: Biosimilars

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.

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Controlled Substances Hospitals 59

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 116

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 59

Pharmaceutical Technology

MAY 9, 2023

There is also the possibility of false-positive results when methamphetamine and related substances are present. “We Interactions with other substances and the chance of false positives related to sample dilution are things to consider with xylazine strips moving forward.”

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Controlled Substances 111

Quality Matters

MAY 23, 2023

This alone can present serious risks to patients’ health and public health. The challenges associated with online pharmacies are not just limited to the distribution of counterfeit medicines – they also include the potential to exacerbate addiction and substance abuse through the availability of controlled substances.

Online Pharmacies 52

Online Pharmacies Controlled Substances Packaging Communication 52

FDA Law Blog: Biosimilars

DECEMBER 21, 2023

Director Larry Houck will present a webinar on HHS’ cannabis rescheduling recommendation hosted by the National Association of State Controlled Substance Authorities (“NASCSA”) scheduled for Tuesday, January 9, 2024 at 3:00 pm (Eastern). Hyman, Phelps & McNamara, P.C.,

Controlled Substances 52

Controlled Substances 52

FDA Law Blog: Biosimilars

MARCH 6, 2025

A series of recent cases has held that, unless there is evidence that the President wants to remove an official but cannot do so because of statutory limitations on his power, there is no judiciable harm presented. Barlow-Ahsan v. Kijakazi , 2023 U.S. LEXIS 185877, at *24-25 (E.D. 17, 2023) (citing cases).

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Controlled Substances 105

FDA Law Blog: Biosimilars

MAY 21, 2024

Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K. 44,597 (May 21, 2024). 29, 2023) (“Basis”); NPRM at 44,603.

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Controlled Substances Chemotherapy Dosage Labelling 69

Pharmaceutical Commerce

JUNE 17, 2025

This is particularly important for sensitive medications such as controlled substances, which can be at a higher risk for counterfeiting and diversion. Additionally, advancements in AI and cloud computing present opportunities to enhance supply chain intelligence.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Coverage and Processing Hospitals Drug Pricing 52

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Houck — With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985, we present “Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not.”* We present the Top Ten Reasons in chronological order of the letters and in order of their appearance in those letters.

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Controlled Substances Chemotherapy Compounding 59

The Thyroid Pharmacist

NOVEMBER 15, 2024

While vitamin B9 can be found naturally in foods in the form of folate, it can also be found in the form of folic acid, a manufactured and synthetic version of folate that is present in most bargain-priced multivitamins, as well as often added to processed foods.

Diabetes 83

Diabetes Immunity Immunization Compounding 83