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 134

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 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

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 73

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

The Checkup by Singlecare

DECEMBER 12, 2024

Semaglutide has become a very popular drug thats in high demand in pharmacies everywhere and is currently also available from compounding pharmacies and online. But not all compounded semaglutide products are safe. Heres what to know about buying semaglutide from a compounded pharmacy or online. What is compounded semaglutide?

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Compounding Compounding Pharmacies FDA Insurance 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

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 100

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 136

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

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

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

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

Pharmacy Times

MAY 28, 2024

Under the proposal, specific drugs would be prohibited

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Compounding FDA 139

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 136

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 141

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

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

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

Pharmaceutical Technology

FEBRUARY 24, 2025

With Novo Nordisks blockbuster drugs Wegovy and Ozempic back in stock, copycat versions are no longer allowed for now.

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Compounding FDA 111

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. Have a grand day, everyone, and do stay in touch. ” A U.S.

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Compounding FDA Compounding Pharmacies Vaccines 100

PharmaVoice

OCTOBER 21, 2024

After initially declaring the shortage of Eli Lilly’s diabetes and weight loss drugs over, the FDA changed its mind and re-opened the door for GLP-1 compounders.

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Compounding FDA 173

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 102

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

Pharmacy Times

NOVEMBER 1, 2024

Martha Rumore, PharmD, Esq, discusses the legal and regulatory complexities surrounding tirzepatide compounding following FDA’s removal of the drug from the shortage list, which prompted a lawsuit and led to ongoing uncertainty for 503A and 503B facilities regarding enforcement discretion and future compounding restrictions.

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Compounding FDA 94

STAT

JULY 25, 2024

Many people were stunned when an FDA advisory committee voted “no” on a new drug application for MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) earlier this summer. Several things were stacked against approval: The FDA greenlights only about 50 new drugs each year. I was not among them.

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FDA Compounding 132

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 FDA 102