This content originally appeared on Everyday Health. Republished with permission.
By Lisa Rapaport
Key Takeaways
- Hims & Hers will sell compounded semaglutide, the active ingredient in Ozempic and Wegovy, starting at $199 per month.
- The company will connect patients with medical providers to get a prescription, if appropriate.
- The FDA does not review compounded medications for safety, effectiveness, or quality.
Direct-to-consumer pharmacy startup Hims & Hers Health says it is selling injectable weight loss medicines made from the same active ingredient as Ozempic and Wegovy, at a fraction of the cost for those name-brand drugs.
Hims & Hers will offer compounded GLP-1 drugs containing semaglutide starting at $199 a month, the company said in a statement.[1] The company won’t take insurance.
Without insurance, Ozempic costs around $1,000 a month and Wegovy costs about $1,300 to $1,500 monthly, according to GoodRx.
“We’ve leveraged our size and scale to secure access to one of the highest-quality supplies of compounded GLP-1 injections available today,” Andrew Dudum, co-founder and chief executive officer of Hims & Hers, said in the statement. “We’re passing that access and value along to our customers, who deserve the highest standard of clinical safety and efficacy to meet their goals, and we’re doing it in a safe, affordable way that others can’t deliver.”
What Is Compounded Semaglutide?
In general, compounded drugs mix, combine, or alter ingredients to make medications that are tailored to the needs of individual patients — for example someone may need a stronger dose than what manufacturers make, or someone may be allergic to an inactive ingredient in the usual formulation.
As of April 30, there were shortages of the three smallest doses of the weight loss drug Wegovy that people need to start treatment, according to the U.S. Food and Drug Administration (FDA). Ozempic, the type 2 diabetes drug with the same active ingredient, is currently available, but had previously been in short supply for months on end. The FDA cited increased demand for semaglutide as the cause of the Wegovy shortage, and offered no indication of when supplies might be widely available again. Supplies of Mounjaro and Zepbound, GLP-1 drugs made with the active ingredient tirzepatide, are also in short supply and will be at least until this summer, according to the FDA.
When there are shortages like this, compounding pharmacies are allowed to make compounded versions so people can still access needed treatment. However, the FDA does not review these compounded versions for safety, effectiveness, or quality.
Earlier this year, the FDA raised concerns that people may experience unanticipated side effects with compounded semaglutide, which may be made with salt-based forms of semaglutide that are different from the active ingredient in Wegovy and Ozempic.
“Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations,” the FDA said in a statement.[2] “Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.”
Amid the ongoing shortages and surging demand for Wegovy and Ozempic, many medical spas, wellness clinics, weight loss clinics, and pharmacies have been selling compounded semaglutide. Drugmaker Novo Nordisk, which makes Wegovy and Ozempic, has sued many of these companies alleging false advertising, trademark infringement, and unlawful sales of non-FDA approved products claiming to be semaglutide, the drugmaker said in a June 2023 statement.[3]
How to Get Compounded Semaglutide Online
Hims & Hers is one of several online pharmacies that prescribe and sell compounded semaglutide directly to consumers. Others include Ro, PlushCare, and Henry.
To get compounded semaglutide through Hims & Hers, customers first have to do an online consultation with a medical provider through the company’s platform, says Pat Carroll, MD, chief medical officer at Hims & Hers.
“These independent providers are required to follow evidence-based clinical protocols and use their own medical judgment to recommend which treatment, if any, is clinically appropriate,” Dr. Carroll says.
Hims & Hers is also partnering with a leading U.S. manufacturer of generic and compounded injectable medicines, Carroll says. The manufacturer is registered with the FDA as what’s known as a 503B outsourcing facility, which means it is subject to FDA oversight.
“Safety and quality are our highest priority when it comes to compounding, and we conducted extensive research for over a year into finding a quality supplier who met our rigorous safety standards,” Carroll says.
How to Know Your Semaglutide Is Safe
FDA spokesperson Amanda Hils said that the FDA generally doesn’t comment on specific websites, companies, or products without a thorough review.
“The FDA’s compounding program aims to preserve access to lawfully marketed compounded drugs for patients who have those needs, while protecting them from poor quality compounded drugs,” Hils said.
“However, consumers should be aware that compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs are not FDA-approved and do not undergo FDA premarket review for safety, effectiveness, or quality,” Hils said. “Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed.”
The only way to know for sure if compounded semaglutide is safe and effective is to have it tested to verify that it actually contains the same active ingredient as Wegovy and Ozempic — and no unanticipated or potentially unsafe ingredients, says Melanie Jay, MD, an associate professor of medicine and director of obesity research at New York University.
“I would want to see a certificate of authenticity from an outside lab that tested the batch of medicine and showed that the medication is authentic,” Dr. Jay says. “I would also want to make sure that they contain the base form of semaglutide that is in the FDA-approved drugs, and not semaglutide salts like semaglutide sodium or semaglutide acetate.”
Given these concerns, some doctors think people are better off avoiding compounded semaglutide.
“There is no way to know what you are getting in compounded semaglutide, despite fancy advertising and attractive prices,” says Jody Dushay, MD, MMSc, an endocrinologist and assistant professor at Harvard Medical School. “It could be harmless and ineffective for weight loss, or it could be frankly dangerous.”
The FDA says online pharmacies are more likely to provide safe and effective medicines if they meet the following criteria:
- Always requires a doctor’s prescription
- Provides a physical address and telephone number in the United States
- Has a licensed pharmacist on staff to answer your questions
- Is licensed with a state board of pharmacy
The FDA also warns that an online pharmacy may be unsafe if it:
- Does not require a doctor’s prescription
- Is not licensed in the United States and by your state board of pharmacy
- Does not have a licensed pharmacist on staff to answer your questions
- Sends medicine that looks different than what you receive at your local pharmacy, or arrives in packaging that is broken, damaged, in a foreign language, has no expiration date, or is expired
- Offers deep discounts or prices that seem too good to be true
- Charges you for products you never ordered or received
- Does not provide clear written protections of your personal and financial information, or sells it to other websites
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