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

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 144

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 163

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

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

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

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

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 97

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

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

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 137

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 FDA 98

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 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.

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Compounding FDA Compounding Pharmacies Communication 69

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

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

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 FDA 96

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 140

STAT

JULY 26, 2023

One of the largest compound pharmacy operations in the U.S. facility run by Central Admixture Pharmacy Services. Yet the compounder failed to investigate the causes or take adequate corrective or preventive actions to mitigate the risk of formation.

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Compounding Hospitals Compounding Pharmacies FDA 98

BuzzRx

OCTOBER 14, 2022

If your doctor’s office has given you a prescription with instructions to fill it at a compounding pharmacy, you might be wondering what exactly this means. There are 56,000 community pharmacies in the US. Only around 7,500 are compounding pharmacies, of which only 3,000 perform sterile compounding.

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Compounding Pharmacies Compounding Dosage Sterile Compounds 52

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 FDA 107

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. 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 100

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 110

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

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 FDA 97

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 Insurance 97

The Checkup by Singlecare

FEBRUARY 14, 2025

It is also commonly prescribed off-label (for non-FDA-approved use) to help with weight loss and weight management in people with obesity or who are overweight with weight-related medical conditions. Enter compounding pharmacies , which create compounded versions of drugs like tirzepatide. What is compounded tirzepatide?

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Compounding Compounding Pharmacies Insurance Coverage FDA 52

STAT

OCTOBER 31, 2024

Food and Drug Administration drug shortage list as of Wednesday , raising the possibility that the medications could soon be taken off the list entirely, a development that could affect compounding pharmacies and patients relying on compounded drugs, STAT reports.

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Compounding Pharmacies FDA Compounding Packaging 103

The Checkup by Singlecare

MARCH 11, 2025

Drug manufacturer Novo Nordisk produces it under the brand name Rybelsus , and the FDA approved it for managing blood glucose in people with Type 2 diabetes but not Type 1 diabetes. Some compounding pharmacies might make semaglutide tablets themselves, but these drugs arent FDA-approved or inspected. mg dose once weekly.

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Compounding Compounding Pharmacies FDA Dosage 52

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 Documentation FDA 71

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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Compounding Compounding Pharmacies FDA 52

The Checkup by Singlecare

FEBRUARY 14, 2025

As a result, many people look for cheaper options or ways to skip the shortage wait, which is where compounded GLP-1s come in. Compounded drugs are custom-made versions of brand-name medications that are often easier to get and may cost less. Read on to learn more about the safety of compounded GLP-1s and the risks behind using them.

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The Checkup by Singlecare

FEBRUARY 13, 2025

When this happens, compounding pharmacies (such as those that work with telehealth companies ) are able to make formulations of a drug that is not readily available. Although compounded versions of tirzepatide, the active ingredient in Zepbound, are becoming popular online, the two drugs are not exactly the same.

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Compounding Insurance Coverage Compounding Pharmacies FDA 52

The Checkup by Singlecare

FEBRUARY 14, 2025

Some people may be drawn to the affordability of compounded semaglutide, hoping to manage costs through insurance. However, most insurance companies dont cover compounded semaglutide, especially for weight loss, leaving many to pay potentially high out-of-pocket costs. What is compounded semaglutide?

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Compounding Insurance Compounding Pharmacies FDA 52

The Checkup by Singlecare

JANUARY 6, 2025

Ozempic (semaglutide) is a brand-name drug made by Novo Nordisk and approved by the Food and Drug Administration (FDA) to help treat Type 2 diabetes. Compounded semaglutide is a medication thats custom-made for you by a compounding pharmacy. An important note: Compounding pharmacies are legitimate and legal.

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Compounding Compounding Pharmacies FDA Dosage 52

The Checkup by Singlecare

APRIL 4, 2025

Food and Drug Administration (FDA) to treat Type 2 diabetes and lower the risk of cardiovascular events and kidney problems in certain adults. Compounded medications Compounded drugs are medications made by altering, combining, or mixing ingredients tailored to meet a persons health needs.

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Compounding Insurance Insurance Coverage Dosage 52

The Checkup by Singlecare

FEBRUARY 13, 2025

It was approved by the Food and Drug Administration (FDA) in 2022 to help control blood sugar levels in adults with Type 2 diabetes , but healthcare providers often prescribe this medicine off-label (for a non-FDA-approved use) for weight loss in people with obesity (or overweight with certain medical conditions).

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Compounding Insurance Coverage Insurance FDA 52