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

The Checkup by Singlecare

JANUARY 9, 2025

Due to the rising demand for weight loss drugs and the resulting drug shortages , some specialized compounding pharmacies make compounded semaglutide injections. Compounded versions of semaglutide contain varying ingredients, and theyre not approved by the U.S. Food and Drug Administration (FDA).

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Compounding Compounding Pharmacies FDA Sterile Compounds 104

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

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 140

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

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

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

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

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

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

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 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 140

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

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

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. We appreciate any and all thoughts and suggestions. … The U.S.

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Compounding Pharmacies Compounding Dosage FDA 111

STAT

FEBRUARY 25, 2025

Food and Drug Administration over its decision last week to remove Novo Nordisk’s weight loss and diabetes treatments Wegovy and Ozempic from the agency’s shortage list, a move that will sharply curtail the ability of compounders to sell cheaper versions of the medicines , Reuters writes.

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Compounding FDA Compounding Pharmacies Communication 89

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 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 114

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

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

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

The Checkup by Singlecare

JANUARY 13, 2025

When there isnt enough supply of prescription medication to meet patient demand, compounding pharmacies can create similar versions, or copies, of the drug to fill the gap. Before Ozempic (semaglutide) became a household name, most people probably didnt think much about compounded medications. Vukasinov says.

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Compounding Compounding Pharmacies FDA Insurance Coverage 98

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 108

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. By law, that should have prohibited compounding pharmacies from making copies of the drug, as they are allowed to do so only when the treatment is on the shortage list.

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FDA Compounding Compounding Pharmacies 101

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 105

The Checkup by Singlecare

FEBRUARY 17, 2025

Its a good idea to be aware of the potential risks and complications associated with compounded semaglutide. Its not safe or effective, according to the Food and Drug Administration (FDA), and it may lead to serious health problems. Compounded semaglutide is a custom-made version made by licensed compounding pharmacies.

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Compounding Compounding Pharmacies FDA Dosage 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 111

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 102

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

Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). Outlook stated that ONS-5010 will get 12 years of regulatory exclusivity in the US if it is approved by the FDA.

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STAT

SEPTEMBER 19, 2024

Novo and rival Eli Lilly, which makes the weight loss drug Zepbound, have filed a flurry of lawsuits against medical spas, wellness clinics, and compounding pharmacies for allegedly selling products claiming to contain the active ingredients in their drugs. Continue to STAT+ to read the full story…

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Compounding Compounding Pharmacies Packaging Insurance 110

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 91

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 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.

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Compounding Compounding Pharmacies Insurance Coverage FDA 52

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.

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Compounding Insurance Coverage Insurance FDA 81

The Checkup by Singlecare

MARCH 7, 2024

Yet the Food and Drug Administration (FDA) hasn’t approved this GLP-1 agonist injection for weight loss. Instead, it’s FDA approved to improve glycemic control in adults with Type 2 diabetes and to reduce the risk of adverse cardiovascular events in adults with Type 2 diabetes and known heart disease.

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Compounding Pharmacies Insurance Insurance Coverage Compounding 93

The Checkup by Singlecare

DECEMBER 30, 2024

If liquid gabapentin is needed, a provider at a compounding pharmacy must prepare it. Additionally, gabapentin is typically used as a human medicine; its prescribed off-label for dogs since it doesnt have FDA approval for them yet. However, the human liquid version should not be given to dogs.

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