Updated FDA order & what it means for you

If you’re using compounded semaglutide, you need to know about the FDA’s latest decision. knownwell is committed to prescribing FDA-approved medications and is here to help.  

With the recent announcement that the shortage of Ozempic ® and Wegovy ® is officially over, the FDA has declared that compounding pharmacies must stop producing and selling compounded semaglutide by May 22, 2025. This decision raises important questions about safety, access, and the best treatment options for weight management.

In this article, we’ll break down:

• What compounded semaglutide is and why it’s being halted

• The risks of using non-FDA-approved medications

• Why FDA-approved GLP-1s and other FDA approved medications are the safest choice for weight loss

• How knownwell helps guide patients through the transition to FDA-approved GLP-1s or other FDA-approved medications

What is compounded semaglutide?

Compounded semaglutide has been used as an alternative to FDA-approved GLP-1 medications during shortages. These injections are created by compounding pharmacies using ingredients from manufacturers that are copying the original FDA approved products  and  are not subject to the same rigorous FDA safety and effectiveness standards as brand-name drugs like Ozempic ® and Wegovy ®.  

FDA’s decision to halt production

With the manufacturer Novo Nordisk now able to produce enough medication such that it is readily available, the FDA has ordered all pharmacies to stop making or selling compounded semaglutide. Starting in May these will be considered illegal medications.  

Risks of Using Compounded Semaglutide

• Not FDA-approved – These medications have not undergone extensive clinical trials for safety and efficacy.  The source medication, the semaglutide, is not the same semaglutide as is made by Novo Nordisk the company that spent years researching the drug and fine tuning its production.

• Adverse effects – These drugs are not being regulated as tightly, which could lead to inconsistent dosages, unverified ingredients, or contaminants, increasing the risk of severe nausea, vomiting, diarrhea, blood sugar fluctuations, allergic reactions, and infections.

• Efficacy - When a person takes a compound, no one really knows what they are injecting into their body. These medications also haven’t been tested to see if they work as well as authentic medications. In some cases they don’t work at all.

• Higher risk of contamination or mislabeling – Without strict quality controls, compounded drugs can be inconsistent in dosage and purity.

• Limited access moving forward – If you rely on compounded semaglutide, your medication may soon be unavailable, requiring a shift to FDA-approved options.

Why FDA-approved GLP-1s are the safest choice

At knownwell, we only prescribe FDA-approved GLP-1 medications because patient safety is our top priority. Here’s why:

• Rigorous Testing – Ozempic ®, Wegovy ®, and other FDA-approved GLP-1s undergo extensive clinical trials to ensure effectiveness and safety.

• Medical Supervision – Our licensed clinicians carefully monitor your treatment plan, ensuring the best results for your health journey.

• Comprehensive Support – Beyond medication, we offer nutrition coaching, mental health support, and long-term care as well as other FDA approved medications for weight management to help you achieve sustainable weight loss.

More cost effective authentic GLP-1 are now available!

Authentic Wegovy ® is now available at Novocare ® pharmacy and your local pharmacy and vials of authentic Zepbound ® are available at Lilly Direct. They’re increasing the supply and lowering the cost to make authentic GLP-1s more affordable and accessible.  

Novo Nordisk's NovoCare ® Pharmacy now offers all doses of FDA-approved Wegovy® (semaglutide) for $499 per month with convenient home delivery options for cash-paying patients. Eli Lilly’s Lilly Direct program provides Zepbound® vials at reduced prices:  

• 2.5 mg dose: Now $349 per month

• 5 mg dose: Now $499 per month

• 7.5 mg dose:  Now $599 per month

• 10mg dose: Now ($699) per month

Additionally, Eli Lilly’s journey program reduces the prices for 1.5mg and 10mg doses to $499 per month at first fill and refills that occur within 45 days of prior delivery.

At knownwell, we’re committed to making evidence-based, FDA-approved GLP-1 and other FDA approved medications for weight management more accessible to our patients. We are able to send prescriptions to Lilly Direct to help eligible patients get authentic Zepbound® vials at lower costs and to Novocare ® for Wegovy ®. Medications such as Qsymia (phentermine/topiramate) and Contrave (naltrexone/bupropion) can also be prescribed via online pharmacies that each company has to get these medications for $99/month.  Our care team can guide you through the process, ensuring seamless prescription management and access to affordable medications to reach your health goals.