GLP-1 (Ozempic, Semaglutide,Tirzepatide) Compounding Legal Updates

[madman]

* The regulatory landscape is changing fast, and staying compliant is critical

If your wellness clinic or med spa is offering (or planning to offer) GLP-1 medications like Ozempic, Wegovy, Mounjaro, or compounded semaglutide/tirzepatide, this legal update is a must-watch.

The regulatory landscape is changing fast, and staying compliant is critical. In this video, we break down everything you need to know from a legal and compliance perspective.




What You’ll Learn:

• Recent FDA Actions & Legal Developments

• Current Legal Status of Compounded GLP-1s

• Consent & Disclosure Requirements

• Scope of Practice: Who Can Prescribe & Administer

• Legal Risks of Off-Label Marketing & Delegation

• How to Stay Compliant in 2025 and Beyond




Have legal questions about offering GLP-1s in your practice? Visit us at LengeaLaw.com or send us a message to schedule a compliance consultation.

 

[madman]

https://www.cnbc.com/2025/04/01/eli-lilly-sues-strive-and-empower-over-compounded-tirzepatide.html

* Empower in a statement said restricting access to personalized alternatives to commercial drugs is not in the best interest of patients, and it’s “committed to offering these life-changing formulations.” Strive called Lilly’s lawsuit a classic example of Big Pharma overstepping legitimate regulations to prioritize its own interests and said it will vigorously defend its position.




Key Points

• Eli Lilly is suing Strive Pharmacy and Empower Pharmacy for compounding Zepbound and Mounjaro.

• Compounding of tirzepatide, the active ingredient in Lilly’s obesity drug Zepbound and diabetes drug Mounjaro, was largely supposed to stop last month.

• Lilly argues Strive and Empower are skirting the FDA’s ban on compounding.

 

[madman]

Eli Lilly - Empower Statement Eli Lilly is Suing Empower. What’s Really at Stake.

Eli Lilly is suing Empower in an attempt to limit patient access to personalized, affordable care. This lawsuit highlights a deeper divide in healthcare—Big Pharma’s profit-driven, one-size-fits-all approach vs. Empower’s commitment to individualized, proactive treatment.

www.empowerpharmacy.com

 

[madman]

Thread 'Revolutionizing Healthcare with Personalized Medicine - DISRUPTING BIG PHARMA'

Apr 8, 2025

In this episode of Entrepreneurs in Recovery, host Jesse Harless welcomes Shaun Noorian, CEO of Empower Pharmacy, the world’s largest compounding pharmacy, to discuss a groundbreaking approach to healthcare. Shaun shares his personal journey, from battling a pituitary disorder and low testosterone to founding a company that’s disrupting Big Pharma by offering personalized, affordable medications.

He dives into the critical role of compounding pharmacies in providing access to life-changing treatments like ketamine therapy for mental health, the...

• madman
• empower pharmacy; compounding; facility; medicatio
• Replies: 0
• Forum: Health & Wellness

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[madman]

Thread 'FDA-Approved vs. Compounded GLP-1s: Comparing Safety, Quality, and Transparency'

Apr 9, 2025

The guest speakers says it all LOL!

The Obesity Society (TOS) convened a panel of leading experts in obesity medicine, pharmacy, and regulatory law on March 19, 2025, to discuss the growing concerns surrounding the use of compounded GLP-1s for weight management and diabetes treatment. The briefing underscored the critical importance of ensuring patient access to safe, FDA-approved GLP-1 medications.

The briefing occurred on the same day as the FDA’s deadline for compounding companies to cease making tirzepatide, according to the FDA’s latest...

• madman
• glp-1; obesity; weight loss; lifestyle
• Replies: 1
• Forum: Health & Wellness

 

[Pacman]

I see that the compounding pharmacies now offer tirzepatide but with additives like B6, B12, Glycine, etc. Has anyone tried these formulations? Do they still work?