STAT

APRIL 29, 2025

The explosion of compounded GLP-1 offerings over the past two years is coming to an end, and many patients are left with no good options.  Businesses are changing prescriptions, mixing in additives, or encouraging stockpiling of existing compounded products. Some have disappeared altogether.

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Compounding Compounding Pharmacies FDA 136

Fierce Pharma

OCTOBER 23, 2024

The war is on between compounding pharmacies making knockoff versions of popular weight loss drugs and pharma giants Novo Nordisk and Eli Lilly, who want to protect their right to sell their patent | Novo Nordisk has asked the FDA to prevent compounders from manufacturing copycat versions of its juggernaut diabetes and obesity treatments Ozempic and (..)

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Compounding Compounding Pharmacies FDA 99

The Checkup by Singlecare

JANUARY 15, 2025

Food and Drug Administration (FDA), such as Rybelsus (oral semaglutide), Mounjaro (tirzepatide), Zepbound (tirzepatide), and Saxenda (liraglutide). Compounded semaglutide is another option, and its lower cost may make it seem like an appealing alternative. What are compounding pharmacies?

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Compounding Compounding Pharmacies FDA Dosage 98

STAT

OCTOBER 30, 2024

With all doses now listed as available, the FDA may soon pull it off the list, depending on its conversations with Novo about whether the company can sufficiently meet demand going forward.   Continue to STAT+ to read the full story…

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Compounding Pharmacies FDA Compounding 137

STAT

FEBRUARY 25, 2025

… Eli Lilly will offer more doses of its obesity drug Zepbound in vials and lower the prices of the doses it already sells, as the company seeks to draw patients away from cheap, compounded copies of weight loss medications , STAT reports. Pharmacy compounders sued the U.S. Continue to STAT+ to read the full story…

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Compounding FDA Compounding Pharmacies Communication 92

STAT

OCTOBER 22, 2024

Novo Nordisk has asked the 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. The FDA still has to make a decision on whether to officially place semaglutide on the lists.

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Compounding Compounding Pharmacies FDA Documentation 145

Drug Topics

FEBRUARY 10, 2023

The FDA has updated its compounding guidelines for licensed pharmacies, hospitals, and health systems.

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FDA Compounding Hospitals 247

STAT

APRIL 29, 2025

Good morning, we’ve got a bunch of news this morning about GLP-1 drugs,  compounding, and biotechs’ interactions with the FDA.   Sign up  to get our biotech newsletter in your inbox. Let’s get into it. Read the rest…

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Compounding FDA 95

The Checkup by Singlecare

FEBRUARY 17, 2025

Many people are turning to compounded versions of semaglutide for various reasons, such as costs and shortages of approved medications like Ozempic and Wegovy. While compounding alternatives might seem appealing, they lack the testing and quality control of their approved counterparts. Is compounded semaglutide safe?

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Compounding Compounding Pharmacies FDA Dosage 52

Fierce Pharma

OCTOBER 8, 2024

With an estimated 2 million people in the United States taking copycat vers | A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.”

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Compounding Compounding Pharmacies FDA 125

Fierce Pharma

DECEMBER 19, 2024

The FDA has doubled down on its decision to remove Eli Lillys tirzepatide from its list of products that are in shortage. | The FDA has doubled down on its decision to remove Eli Lillys tirzepatide from its list of products that are in shortage.

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Compounding Pharmacies FDA Compounding 100

The Checkup by Singlecare

MARCH 31, 2025

Ozempic and Wegovy (and Rybelsus , which is oral semaglutide) are GLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists, commonly referred to as GLP-1s) and are the only FDA-approved drugs that contain the active ingredient semaglutide. Some facilities add B12 to their compounds, in addition to semaglutide.

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Compounding Compounding Pharmacies FDA Adverse Reactions 52

STAT

JANUARY 7, 2025

That could include anything from modeling to cut down on animal-based toxicology studies to developing AI-based clinical trial endpoints to evaluating adverse events after the FDA approves a drug.    Most of the compounds came from commonly prescribed medications including antidepressants and statins.

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FDA Compounding Documentation 101

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 FDA 162

STAT

OCTOBER 8, 2024

A trade group representing large compounding pharmacies has sued the U.S. Moreover, the trade group maintained the FDA move was “unlawful,” because it failed to follow so-called rule-making procedures and provide proper notice of its plans. Continue to STAT+ to read the full story…

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Compounding FDA Compounding Pharmacies 139

STAT

MAY 6, 2025

By 2024, one-third of their new compounds were coming from Chinese biotechnology firms. As in many other industries, it’s so much cheaper to synthesize new compounds inside Chinese biotechnology firms once a novel biological target has been discovered in American laboratories. Five years ago, U.S. Why are U.S.

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Compounding Pharmaceutical Companies Pharmaceutical Companies FDA 143

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 FDA 110

Fierce Pharma

MAY 31, 2023

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02

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Compounding FDA 126

Pharmacy Times

DECEMBER 20, 2024

Compounding pharmacies have a 60- to 90-day grace period to complete production as it continues to monitor supply and demand.

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Compounding Compounding Pharmacies FDA 139

DiversifyRx

APRIL 29, 2025

Should You Keep Compounding GLP1s (Tirzepatide or Semaglutide) After the FDA Deadline? Howdy pharmacy peeps… Lets have a real talk about compounding GLP1s. These compounds have been huge revenue drivers and powerful tools for helping patients lose weight and improve metabolic health. Here’s My Take.

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Compounding Sterile Compounds FDA Compounding Pharmacies 52

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 FDA 111

STAT

APRIL 25, 2025

Scores of FDA employees are searching for an exit from an agency in turmoil, particularly staff members tasked with reviewing drug applications. As many as 600 drug reviewers have recused themselves from approval processes because they are interviewing with drug companies, according to former FDA Commissioner Scott Gottlieb.

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Compounding FDA 87

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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Compounding Compounding Pharmacies FDA 116

Fierce Pharma

OCTOBER 14, 2024

Four days after a compounding industry group filed a lawsuit against the FDA | Four days after a compounding industry group filed a lawsuit against the FDA for removing Eli Lilly’s tirzepatide products from its shortage list, the U.S. regulator is taking a second look at its decision.

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Compounding FDA 116

Pharmacy Times

OCTOBER 25, 2024

The call follows the FDA’s sudden removal of tirzepatide from the drug shortage list, preventing compounding pharmacies from providing the drug.

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Compounding Pharmacies Compounding FDA 132

Pharmacy Times

APRIL 7, 2023

Part 1 of this 2-part series examines USP and revisions for sterile and nonsterile compounding, veterinary compounding, FDA inspections of 503A pharmacies, and the interstate distribution of compounded prescriptions post Wellness Pharmacy v.

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Compounding FDA 123

The Checkup by Singlecare

JANUARY 13, 2025

A compounded medication is a custom formulation of an existing brand-name or generic drug made by a licensed pharmacist and designed to meet a patients unique needs. For example, a person who is allergic to a common dye included in a prescription drug could have a compounded version of the drug made without that dye.

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Compounding Compounding Pharmacies FDA Insurance Coverage 98

The Checkup by Singlecare

APRIL 15, 2025

Mounjaro (tirzepatide) is a brand-name prescription medication that is approved by the Food and Drug Administration (FDA) to improve blood sugar levels in people with Type 2 diabetes. The FDA recently approved generic versions of two other GLP-1s , Victoza (liraglutide) and Byetta (exenatide). Is there a generic for Mounjaro?

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Compounding Dosage Compounding Pharmacies FDA 85

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 FDA Compounding 139

Pharmacy Times

SEPTEMBER 13, 2022

Prescribers signed a letter expressing concerns about recommendations for restrictions on compounded hormones, which millions of women and other patient populations rely on.

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Compounding FDA 117

STAT

OCTOBER 25, 2024

Earlier this month, the FDA declared an end to the shortage of Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, after almost two years. 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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FDA Compounding Pharmacies Compounding 143

PharmaVoice

DECEMBER 20, 2024

The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

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Compounding Pharmacies FDA Compounding 130

STAT

JULY 26, 2023

One of the largest compound pharmacy operations in the U.S. For example, there were 100 instances between November 2022 and March 2023 in which the company found what the FDA called a “significant number” of bacteria, yeast, mold, and other spore-forming organisms. facility run by Central Admixture Pharmacy Services.

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Compounding Hospitals Compounding Pharmacies FDA 98

Pharmacy Times

MAY 28, 2024

Under the proposal, specific drugs would be prohibited

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Compounding FDA 139

Fierce Pharma

JUNE 20, 2023

Three weeks after the FDA warned that some pharmacies are making unauthorized versio | Novo Nordisk filed five lawsuits in four states on Tuesday, charging health spas, clinics and pharmacies with false advertising, trademark infringement and unlawful sales of compounded versions of diabetes and weight loss drugs Ozempic and Wegovy.

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Compounding FDA 124

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 FDA 98

The Checkup by Singlecare

DECEMBER 12, 2024

Ozempic is also sometimes prescribed off-label (for a non-FDA-approved use) as a weight loss drug. With the popularity of glucagon-like peptide 1 receptor agonists ( GLP-1 agonists ) like Ozempic, you may have seen advertisements for compounded semaglutide. That includes compounded semaglutide. This is the case with semaglutide.

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Compounding Insurance Coverage Insurance FDA 81