STAT

OCTOBER 8, 2024

A trade group representing large compounding pharmacies has sued the U.S. Food and Drug Administration for a “reckless and arbitrary” decision to remove a widely prescribed Eli Lilly drug for combating diabetes and obesity from an official shortages list.

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Compounding Compounding Pharmacies Diabetes Drug Pricing 347

STAT

OCTOBER 6, 2023

judge dismissed its lawsuit accusing a compound pharmacy of selling versions of its Wegovy and Ozempic medicines, which are widely prescribed for weight loss and have become franchise products for the drug company. The drug maker argued the compounders were selling versions of its medicines that were never approved by the U.S.

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Compounding Compounding Pharmacies 297

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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Compounding Labelling Hospitals 268

STAT

MARCH 5, 2025

Novo Nordisk will start selling its obesity drug Wegovy directly to patients at a reduced price, following a similar move from Eli Lilly as the two drugmakers compete for market share and try to draw patients away from compounding pharmacies that have been making cheaper copies of weight loss drugs.

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Compounding Pharmacies Compounding 285

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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Compounding Compounding Pharmacies Chemotherapy 274

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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Compounding Pharmacies Compounding Hospitals 246

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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Compounding Compounding Pharmacies Packaging 263

STAT

OCTOBER 23, 2024

Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.

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Compounding Compounding Pharmacies Biosimilars Documentation 259

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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Compounding Pharmacies Compounding 246

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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Compounding Hospitals Compounding Pharmacies 246

STAT

MARCH 20, 2025

Food and Drug Administration wants bulk production of copycat versions of popular weight-loss drugs to stop, but telehealth companies and compounding pharmacies that have fueled widespread use of the knockoffs have other plans , The Wall Street Journal writes. And some pharmacies making the GLP-1 drug copycats will continue.

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Compounding Pharmacies Compounding Dosage 263

STAT

DECEMBER 20, 2024

The agency will give compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients. That should have prohibited compounders from continuing to make copies, because they can do so only when a treatment is on the shortage list.

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Compounding Diabetes 264

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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Compounding 332

STAT

FEBRUARY 7, 2025

wrote that they worry that the Hims ad, which will be seen by millions of people during the big game on Sunday, “risks misleading patients by omitting any safety or side effect information” about the compounded weight loss drugs that it promotes. Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.)

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Compounding 233

STAT

JANUARY 7, 2025

 The plants’ inability to remove compounds known as organofluorines from wastewater before they enter drinking water supplies becomes even more pronounced during droughts and could affect up to 23 million people.    Most of the compounds came from commonly prescribed medications including antidepressants and statins.

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Compounding Documentation 254

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 246

STAT

DECEMBER 4, 2024

  A trade group for compounding pharmacies slammed an attempt by Novo Nordisk to convince the U.S. Food and Drug Administration that semaglutide — the key ingredient in its diabetes and obesity drugs — should be added to a list of medicines that are too difficult to compound.

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Compounding Compounding Pharmacies Diabetes Documentation 198

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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Compounding Compounding Pharmacies Diabetes 252

STAT

JANUARY 22, 2025

” Experts told STAT there’s been a surge of interest for these compounds from biotech and pharma in the last few months, spurred on most by the presentation of promising clinical data from Summit Therapeutics.

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Immunity Immunization Compounding Drug Development 361

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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Compounding Compounding Pharmacies Vaccines Immunity 254

STAT

AUGUST 29, 2024

Hims & Hers, one of the largest publicly traded telehealth companies in the country, has supercharged its business in the last several months by offering compounded versions of the patented weight loss drugs known as GLP-1s. That has regularly been the case lately with GLP-1 drugs marketed by Novo Nordisk and Eli Lilly.  

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Compounding 360

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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Compounding Pharmacies Compounding Diabetes 347

STAT

SEPTEMBER 21, 2024

First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.

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Compounding 315

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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Compounding Pharmacies Compounding Diabetes 357

PharmaVoice

DECEMBER 11, 2024

The agency has yet to make a decision about keeping tirzepatide on or off of its shortage list — letting compound pharmacies continue their lucrative operations for now.

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Compounding Compounding Pharmacies 162

STAT

MARCH 3, 2025

The ad, asking patients to “be a healthy skeptic,” was released soon after a commercial from telehealth firm Hims & Hers, selling a compounded weight loss drug, premiered at the Super Bowl. Continue to STAT+ to read the full story…

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Compounding Documentation 176

STAT

FEBRUARY 6, 2025

Food and Drug Administration to “take action” against a “dangerous” ad that Hims & Hers plans to run during the Super Bowl promoting the use of compounded versions of GLP-1 drugs for combating obesity. “The commercial is misleading in its entirety,” the industry group wrote to the agency.

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Compounding 256

STAT

OCTOBER 10, 2024

Top of the morning to you and a fine one it is. Blue skies, cool breezes, and plenty of chirping birds are enveloping the comfy Pharmalot campus, which is cause to fire up the coffee kettle for yet another cup of stimulation. Our choice today is strawberry creme — sweets for the sweet, you know.

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Compounding 255

PharmaVoice

DECEMBER 5, 2022

GATC Health is driving a novel approach it believes could work for several major neurological conditions.

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Compounding 262

Compounding Pharmacy of America

DECEMBER 23, 2024

Learn how compounding pharmacies ensure safety and reliability through rigorous standards, sterile preparations, and personalized solutions for unique healthcare needs. The post Are Compounding Pharmacies Safe? Everything You Need to Know appeared first on Compounding Pharmacy of America.

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Compounding Pharmacies Compounding 98

STAT

JULY 20, 2023

The tornado that struck parts of North Carolina on Wednesday not only damaged the immediate area, but could soon make it much harder for countless people across the U.S. and around the world to obtain needed medicines the next time they visit a hospital. Among the damaged buildings was a Pfizer plant in Rocky Mountain, N.C. hospitals.

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Compounding Hospitals 246

BioPharma Dive

DECEMBER 2, 2024

The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.

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Compounding Compounding Pharmacies Diabetes 120

STAT

OCTOBER 20, 2023

Hospitals’ reliance on pharmacist-made drugs, a practice called compounding, has risen in step with worsening drug shortages. When the American Society of Health-System Pharmacists surveyed its members this past summer, 59% said they increased purchases from compounders because of drug shortages.

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Compounding Chemotherapy Hospitals Drug Development 311

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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Compounding Pharmacies Compounding Diabetes 280

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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Compounding Compounding Pharmacies Diabetes 110

STAT

OCTOBER 24, 2023

A traditional Chinese medicine compound used for cardiac benefits might help reduce the incidence of major adverse cardiac and cerebrovascular events and even cardiac death rates, according to a new study published Tuesday in the Journal of the American Medical Association. However, some outside experts expressed skepticism about the result.

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Compounding 302

pharmaphorum

JANUARY 6, 2025

Novo Nordisk has asked the FDA to block compounders from making versions of its older, once-daily GLP-1 agonist liraglutide.

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Compounding 111