FDA Ban on Compounded GLP-1 Drugs: What to Know

The manufacturer of Ozempic offers a savings card for people who have insurance coverage and are using Ozempic for diabetes treatment. Coupons aren’t currently available to people who are using Ozempic only for weight loss. Always consult a healthcare professional, like a doctor or pharmacist, before making decisions about medication purchases to help make sure the drugs align with your specific health needs. Ozempic is also becoming increasingly popular for weight loss, which is an off-label use. However, in 2021, the FDA approved semaglutide, the same active drug in Ozempic, under the brand name Wegovy as a weight loss medication. Based on your initial visit and lab work, your healthcare professional will determine whether Ozempic or another weight loss medication is appropriate.

The doctor will also order labs and a blood pressure check, just to be on the safe side. Compared with many rivals’ services, we found them to be easy to understand and accessible as a Semaglutide provider. We’re glad to see how many people have had a good experience with Ro, and we’d say they’re worth looking into if you’re exploring the possibilities of weight loss with Semaglutide. Found also does much better than average when you look at customer feedback beyond the BBB. On Trustpilot, more than 71% of the 550+ reviews are a perfect 5 stars; only 16% of reviewers left a 1-star rating.

She also holds a Master’s in Biomedical Engineering from the University of Wisconsin-Madison. The views expressed by authors and contributors of such content are not endorsed or approved by Fay and are intended for informational purposes only. The content is reviewed by Fay only to confirm educational value and audience interest. You are encouraged to discuss any questions that you may have about your health with a healthcare provider. For individuals without insurance, there may be assistance programs available to help qualifying individuals access semaglutide medications at reduced costs. If you are eligible for compounded semaglutide as a medical exception, please contact your insurance provider to learn if they will cover the cost of the compounded meds.

Amanda Bonello, founder and CEO of the GLP-1 Collective, a nonprofit organization aiming to help patients access these medications, is not surprised at the lengths patients are going to. Bonello, who herself has taken compounded GLP-1 products, says for many patients she’s spoken to, the impact of these medications is not just about the weight itself. If you’re interested in trying semaglutide, talk with a healthcare professional about whether it would be a good fit for your needs. Depending on your reason for taking it, insurance may cover some or all of the cost. If you’re interested, you may also be able to participate in a clinical trial for semaglutide medication.

In this medical gold rush, Roth sees echoes of an earlier massively hyped medicine-turned-cultural-phenomenon. In fact, both Ro and Hims started as telehealth companies selling ED medications. In addition to the sharp rise in telehealth providers offering compounded products, there’s also a wild cottage industry of outright Ozempic counterfeits, as Vanity Fair detailed last month. Brick-and-mortar med spas advertising online are also thriving in the Fauxcempic Era, and they often also offer compounded GLP-1 meds, in addition to allegedly appetite-suppressing supplements.

Costs of Semaglutide With Insurance

You can also schedule a follow up visit with your provider to discuss any adjustments to your treatment plan. Compounded GLP-1 medications like semaglutide are injected once weekly in the fatty layer under the skin of the stomach, thigh, or upper arm. If prescribed, you will receive usage instructions including details on how to use the medication. Yes, but Healthon’s licensed providers handle all assessments online. Once approved, your treatment is shipped directly to your door with no need for in-person visits.

FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss

The manufacturer has set the cost of these medications extremely high, which makes it very expensive for patients, especially those without insurance. NiceRx is an online prescription drug savings and telehealth company that connects you with licensed U.S. clinicians and pharmacies. Compounded drugs are prepared by state-licensed pharmacies following state and federal guidelines but are not FDA-approved or evaluated for safety or effectiveness. Compounding involves creating personalized medications to meet specific patient needs, such as making a liquid form of a drug typically available only as a pill or addressing shortages of FDA-approved medications. Compounded semaglutide is sometimes used as part of a professional plan to help manage weight and promote healthy aging, under licensed medical supervision.

Pharmacies can dispense compounded semaglutide that was produced before the May 22, 2025 deadline, until its expiration date 1.2.4, 1.6.6. However, you should speak with your doctor about the safest way to transition to an FDA-approved medication. Compounding pharmacies are only allowed to create custom versions of medications when the brand-name version is in short supply. This previously included GLP-1 medications like Ozempic® and Wegovy®, which contain Semaglutide. Chandana Balasubramanian is a science writer who loves to translate complex science into clear insights on metabolism, weight management, nutrition, and much more. She is an experienced healthcare executive and the President of Global Insight Advisory Network.

Compounded semaglutide side effects

It costs $49 for the first month and $139/month after, with a minimum commitment of 3 months (though some plans may have a 12-month requirement). You’ll work with a certified nurse-practitioner – which, by the way, is different from many rivals’ services that partner you with a board-certified physician – to go over your weight goals and the results of your required blood testing. The initial lab work will be ordered by the practitioner and can be done at any nearby Quest lab; if you’ve had the same lab work run (maybe for an annual physical) within the last 6 months, you can upload those results instead. Ro believes that the most successful approach to weight loss includes not just an injection but also coaching tailored to your unique profile. You’ll pay $99 for the first month, and that includes the physician review of your Ro application and medical profile. After the first month, Body costs $149/month for as long as you’re using Semaglutide through Ro.

Compounding is nothing new despite only being thrust into the spotlight as of late. Before the days of Big Pharma, every pharmacist “compounded” drugs by combining ingredients to create a medication for a patient. I mean, we’ve spent 15 minutes talking about what a compound is, the different types oral semaglutide dissolving tablets of pharmacies, and all these regulations. Health literacy is pretty low in this country, so being able to wrap our heads around what these medications are is a pretty tall order for patients. It’s definitely going to necessitate providers to have these open relationships with patients to know what they’ve been taking so that they can further advise them, so that they can be really safe with what they’re putting into their bodies. I also think that this creates a big risk in interrupting medication, if a patient can’t just refill a compounded version that no longer is allowed to be made.

  • The agency also encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide or tirzepatide.
  • Due to the high cost and limited availability of brand-name semaglutide products, compounded options have become a popular alternative.
  • When drugs are officially in shortage, the US allows pharmacies to make their own “compounded” versions of them.
  • When you click the „Book” button, you’ll be asked to create a PlushCare account.

Novo Nordisk ends Hims & Hers deal

The most common side effects with GLP-1 medications including compounded semaglutide are gastrointestinal-related such as nausea, diarrhea, and vomiting. Compounding advocates say that, although the drugs are not FDA-approved, they are still subject to rigorous quality control, in part due to post-2012 rule changes. Carroll, for example, says Hims did “due diligence” when choosing its pharmacy and that it has been satisfied with the medication quality. “No untoward side effects that we didn’t anticipate.” According to Carroll, Hims has not had to report any adverse effects to the FDA. In 2012, a compounding pharmacy caused a fungal meningitis outbreak that killed at least 64 people, among the worst pharmaceutical drug-contamination disasters in the United States. The supervisory pharmacist who oversaw the manufacture of this medicine was sentenced to prison time, and the event led to tightened oversight and licensing requirements for compounders.

NAD Injections vs IV Therapy: Which One Should You Choose

Health care providers should be vigilant when prescribing compounded semaglutide or tirzepatide products and determining appropriate doses and titration and dosing schedules for patients. The agency also encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide or tirzepatide. Compounded drug products from our 503A facility are available only through a valid prescription from your healthcare provider. Compounded drug products from our 503B facility are only available for order by licensed healthcare providers. Compounded products are not FDA-approved and have not been evaluated by the FDA for safety or efficacy. Traveling with Semaglutide / Cyanocobalamin Injection requires advance planning to ensure proper storage and compliance with transportation regulations.

In fact, the only way we’ve seen to get any kind of refund is if you don’t lose 10% of your starting weight after being on the Calibrate program for a year, with or without medication. It’ll start with a text message, and then you’ll confirm your name and address as it appears on your government-issued ID. Once you’ve confirmed your identity, you’ll review your cart (the Semaglutide option you selected), enter your shipping and payment info, and check out. A Strut physician will review all of your information; if he or she approves it with no further questions, your Semaglutide will ship out with no interaction with that doctor. Fortunately, you get free, unlimited doctor follow-ups while you’re using Semaglutide with Strut.