Compounding - Pharmacist Digest

STAT+: Lilly sues compounders, wellness centers and spas over unapproved versions of Mounjaro

STAT

SEPTEMBER 20, 2023

As the gold rush over weight-loss drugs accelerates, Eli Lilly filed lawsuits against several compounding pharmacies, spas and wellness centers around the U.S. The drug company accused four compound pharmacies of violating state laws because those versions were not approved by the U.S.

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STAT+: Pharmalittle: We’re reading about a rare-disease drug bill, compounded Wegovy, and more

STAT

SEPTEMBER 19, 2024

Hims & Hers Health plans to sell compounded versions of Novo Nordisk’s popular weight loss drug Wegovy to patients in certain professions for $99 a month , Reuters says. Compounded GLP-1 injections are fulfilled and shipped from Hims & Hers affiliated pharmacies and are regulated by the FDA.

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STAT+: Pharmalittle: We’re watching a ban compounded versions of GLP-1s, a Biogen acquisition, and more

STAT

MAY 22, 2024

Australia to ban compounded versions of blockbuster drugs Ozempic and Mounjaro, Reuters reports. But the country’s health minister, Mark Butler, says that it’s harder to ensure the safety of compounded drugs, noting that one Australian was hospitalized after taking a compounded GLP-1 product.

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STAT+: Pharmalittle: AbbVie buys Immunogen, maker of targeted cancer drugs; Novo sues two more compounders

STAT

NOVEMBER 30, 2023

Novo Nordisk filed lawsuits against two compounding pharmacies for selling adulterated and misbranded compounded drugs claiming to contain semaglutide, the active ingredient in Wegovy and Ozempic (see here and here ). Testing of compounded drugs from these pharmacies revealed unknown impurities up to 33%, the company claims.

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Opinion: Compounding pharmacies offer a fix for shortages of essential drugs

STAT

MAY 15, 2023

At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued temporary guidance allowing traditional compounding pharmacies, within tight regulatory guardrails, to prepare 13 Covid drugs from pure ingredients to meet hospitals’ urgent need.

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Novo joins Lilly in asking FDA for ban on GLP-1 compounding

pharmaphorum

OCTOBER 23, 2024

Novo Nordisk has asked the FDA to stop compounding pharmacies making cheaper versions of its semaglutide-based therapies for obesity and diabetes, saying the drug is too complex to be made safely by these manufacturers.

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STAT+: FDA inspection underscores problem at major U.S. compounder behind hospital drug recalls

STAT

JULY 26, 2023

One of the largest compound pharmacy operations in the U.S. Yet the compounder failed to investigate the causes or take adequate corrective or preventive actions to mitigate the risk of formation. The Food and Drug Administration found several issues that raised the possibility of contamination during an inspection of an Allentown, Pa.,

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Strengthening Regulatory Framework for Compounded Medications

PharmExec

OCTOBER 28, 2024

Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding explain how the regulatory framework for compounded medications can be further strengthened to ensure quality and safety, while still maintaining flexibility to address patient needs.

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FDA rethinking block on compounding of Lilly's obesity drug

pharmaphorum

OCTOBER 14, 2024

Faced with lawsuit, FDA rethinks block on compounding pharmacies making Eli Lilly's diabetes and obesity drug tirzepatide

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STAT+: What to know about concerns raised about compounded versions of Novo Nordisk’s Wegovy

STAT

AUGUST 10, 2023

In late May, the Food and Drug Administration said it received a “few” adverse event reports concerning compounded versions of the injectable medicines, which both contain the same active ingredient, known as semaglutide.

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Compounding Diabetes

Opinion: Compounded semaglutide is an ill-defined public health crisis

STAT

SEPTEMBER 13, 2024

I first met Jane (not her real name, of course) on a Friday afternoon in our clinic. She was referred for further evaluation of her chest pain, which, in the context of her family history of early-onset heart attacks and her morbid obesity, understandably concerned her primary care doctor.

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Advantages & Disadvantages of Using Compounded Medications

PharmExec

OCTOBER 24, 2024

Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding discuss how compounded medications differ from commercially available drugs in terms of their manufacturing process, quality standards, and more.

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STAT+: Pharmalittle: We’re reading about compounders suing the FDA, Biogen turning to telehealth, and more

STAT

OCTOBER 8, 2024

… A trade group representing large compounding pharmacies has sued the U.S. So join us as we hoist the ever-present cup of stimulation — our choice today is coconut rum — and attack the fast-growing to-do list. Have a grand day, everyone, and do stay in touch.

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STAT+: FDA and large compound pharmacies settle a long-running dispute over a key list for ingredients

STAT

OCTOBER 12, 2022

Food and Drug Administration and a trade group that represents large compound pharmacies have resolved a long-running dispute over the use of bulk ingredients, clearing the way for some compounded medicines to become available more quickly. Continue to STAT+ to read the full story…

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Experts Weigh-In on Compounded GLP-1/Semaglutide Solution

PharmExec

NOVEMBER 6, 2024

Industry experts comment on the increasing popularity of compounded medications, particularly GLP-1s, due to drug shortages and the desire for personalized treatments.

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Strive Compounding Pharmacy Eyes Expansion, Purchases St. Louis Facility

Pharmaceutical Commerce

NOVEMBER 14, 2024

The 50,000 square-foot plant is expected to augment the compounding and fulfillment experience for telehealth companies.

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Clearmind licenses psychedelic compounds for mental disorders

Pharmaceutical Technology

APRIL 18, 2024

psychedelic compounds for mental disorders. Clearmind Medicine has entered into a licensing agreement with Yissum to develop Generation 3.0

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The History of Pharmaceutical Compounding

Compounding Pharmacy of America

FEBRUARY 19, 2024

The history and evolution of compounding medications goes back several decades, and over time, the practice has become more beneficial for patients. The post The History of Pharmaceutical Compounding appeared first on The Compounding Pharmacy of America.

Compounding

STAT+: Pharmalittle: We’re reading about a weight loss pill, the FDA warning a compounder, and more

STAT

NOVEMBER 4, 2024

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so predictable routine of online meetings, phone calls, and deadlines has returned. But you knew this would happen, yes? The world, such as it is, continues to spin.

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Advancements in Compounding – A Commitment to Integrity and Quality

epicur

OCTOBER 29, 2024

Below, Jamie shares her perspective on the advancements in compounding based on her visit to the Stokes Healthcare facility. The Complexities of Laws and Regulations around Compounding We also discussed updated pharmacy regulations regarding compounding laws. Creativity is the key more often than not.

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STAT+: Pharmalittle: Lilly sues spas and compounders over ‘unapproved’ Mounjaro; nasal-spray EpiPen alternative suffers setback

STAT

SEPTEMBER 20, 2023

… As the gold rush over weight-loss drugs accelerates, Eli Lilly filed lawsuits against several compounding pharmacies, spas and wellness centers around the U.S. The drug company accused four compound pharmacies of violating state laws because those versions were not approved by the U.S.

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US FDA flags dosing risks from compounded versions of Novo’s weight-loss drug

Express Pharma

JULY 28, 2024

Food and Drug Administration recently warned patients and doctors about dosing errors associated with compounded versions of Novo Nordisk’s weight-loss and diabetes drugs. It urged healthcare providers and compounders to provide the appropriate syringe size and counsel patients on how to measure the dose,” informed the statement.

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Compounding Diabetes

STAT+: In stark reversal, FDA to reconsider removal of Eli Lilly weight loss drug from shortage list

STAT

OCTOBER 11, 2024

The Food and Drug Administration on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, from its shortage list, and, for the time being, would not pursue regulatory action against certain compounding pharmacies making copies of the drugs.

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Top Ten Medications That Can Be Compounded

Compounding Pharmacy of America

NOVEMBER 13, 2023

Certain patients may need specific treatment that requires compounded medications. Learn more about the top compounded medications. The post Top Ten Medications That Can Be Compounded appeared first on The Compounding Pharmacy of America.

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Is Compounding the Answer to the Semaglutide Shortage? Experts Weigh In

Pharmaceutical Commerce

OCTOBER 30, 2024

In this Q&A, Scott Brunner, CEO, and Tenille Davis, Chief Advocacy Officer, of the Alliance for Pharmacy Compounding discuss the challenges faced by patients and healthcare providers due to drug shortages, particularly for semaglutide and other medications.

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Aligos Therapeutics gets grant for patent granted for compounds treating diseases and conditions

Pharmaceutical Technology

JUNE 10, 2024

Discover the groundbreaking patent by Aligos Therapeutics for compounds targeting hepatitis B and D. Learn about the innovative methods for treatment and synthesis.

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What to Do When You Can’t Find the Compounded Medications You Are Looking For?

epicur

OCTOBER 14, 2024

The latest updates to the United States Pharmacopeia (USP) compounding standards’ beyond use date (BUD) guidelines have done just that for many veterinary practices, making it more difficult to source the compounded medications they need for their patients in a timely manner through traditional 503A compounding pharmacies.

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STAT+: Eli Lilly weight loss drug shortage underscores deeper issues with FDA oversight

STAT

OCTOBER 25, 2024

By law, that should have prohibited compound pharmacies from making copies of the drug, as they’re allowed to do so only when the treatment is on the shortage list. The agency then made a sudden about-face , saying it would reconsider its decision and allow compounders to continue for the meantime.

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Is Compounding Pharmacy Right For You?

The Happy PharmD

JULY 4, 2024

Are you considering a career in compounding pharmacy? Let me take you on a journey into the world of compounding pharmacists, where we dive into everything from job satisfaction to salary expectations. In terms of demand, the future looks promising for compounding pharmacists.

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STAT+: Novo Nordisk’s Ozempic and Wegovy, long in shortage, are now listed as available by FDA

STAT

OCTOBER 30, 2024

Over the past two years, patients seeking treatment have been turning to compounding pharmacies, which make cheaper copies of branded treatments and are legally allowed to do so only when the branded treatments are listed on the FDA’s shortage list.

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Sustainable PFAS-free synthesis for pharmaceutical compounds

European Pharmaceutical Review

AUGUST 30, 2024

Researchers have developed an innovative synthesis method for pharmaceutical compounds that does not require the use of PFAS reagents. highlighted that synthesis of many pharmaceutical compounds “often requires bespoke fluorinated reagents”. Thus, their research is important because PFAS compounds are set to face future legislation.

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NABP’s Compounding Pharmacy Accreditation Shows Your Pharmacy’s Alignment to USP Standards

National Association of Boards of Pharmacy

OCTOBER 16, 2024

On November 1, 2023, long-awaited revisions to the United States Pharmacopeia (USP) Chapters <795>: Pharmaceutical Compounding – Nonsterile Preparations and <797>: Pharmaceutical Compounding – Sterile Preparations became official. Chapters <795> and <797> present the standards for preparing compounded medications.

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Merck gets grant for patent granted for tricyclic heterocycle compounds for treating HIV

Pharmaceutical Technology

APRIL 1, 2024

Discover the groundbreaking patent by Merck & Co Inc for Tricyclic Heterocycle Compounds to combat HIV infection. Learn about the innovative formula and treatment methods for a potent solution in antiretroviral therapy.

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Significant strides made in Nxera Pharma's oral compound for neurological conditions

Outsourcing Pharma

MAY 9, 2024

has initiated its phase 1 clinical study, marking a significant stride in the evaluation of NBI-1117567, an investigational small molecule, oral compound developed by Nxera Pharma. Neurocrine Biosciences Inc.

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Noom offers cut-price compounded GLP-1 drug for obesity

pharmaphorum

SEPTEMBER 18, 2024

Digital health company Noom has launched a compound pharmacy-made version of Novo Nordisk's obesity drug semaglutide to make the drug more accessible to consumers in the US.The bold move has been accompanied by a full-page ad in the Wall Street Journal explaining its reasoning, and claiming that the prices of GLP-1 drugs for weight loss are five times (..)

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Compounded Pain Medication: Customized Relief for Chronic Pain

Compounding Pharmacy of America

AUGUST 24, 2023

Rather than suffering, compounded solutions can be customized to provide relief. The post Compounded Pain Medication: Customized Relief for Chronic Pain appeared first on The Compounding Pharmacy of America. Chronic pain is debilitating for many.

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