Hims & Hers Weight Loss Shots: What You Need To Know About The $199 Compounded Drug (2024)

Compounded drugs are customized medications blended, combined and altered by a licensed pharmacist or medical professional to fit an individual’s unique prescriptive needs, such as needing to avoid an ingredient due to allergies or dosing tolerance.

Individual and small-scale compounded drugs are produced with prescriptions at state-licensed 503A compounding facilities like community or hospital pharmacies. Larger quantities of compounded medications can be produced at FDA-registered 503B outsourcing facilities, which can manufacture and distribute pharmaceuticals without individual prescriptions. These larger outsourcing facilities can produce drugs that are exactly the same or very similar to those on the FDA shortage list, such as semaglutide and other GLP-1 injectables.

Are Compounded Drugs FDA Approved?

Compounded drugs aren’t FDA-approved. However, when drugs, such as semaglutide, are listed on the FDA shortage list, some restrictions—like those preventing companies from compounding copies of previously approved drugs—are relaxed. This allows other companies to create replicas and expand access.

While compounded drugs can help meet the needs of individuals unable to take an FDA-approved medication or who face a drug shortage, these pharmaceuticals can pose a greater risk to users than federally approved drugs, which undergo extensive testing for quality and safety, according to the FDA.

“I do not support the use of compounded semaglutide,” says Adrienne Youdim, M.D., a Forbes Health Advisory Board member specializing in medical weight loss and clinical nutrition. “Compounded drugs are not FDA regulated and therefore are not subject to the same scrutiny in terms of ingredients and production.”

In 2023, the FDA issued a warning about compounded GLP-1 semaglutide injections after receiving reports of side effects and adverse events.

Further, some compounded versions of semaglutide may contain the salt form of the ingredient, as opposed to the base form present in Wegovy and Ozempic, which has neither been shown to be effective or safe for treating diabetes or obesity.

Hims & Hers semaglutide injectables contain the same active ingredient as Wegovy and Ozempic, both of which are FDA-approved drugs commonly used for diabetes and weight loss. The injectable is designed to be used once a week as part of a broader weight-loss plan including dietary and lifestyle changes. The Hims & Hers semaglutide injectable is not FDA approved.

“All of our offerings are delivered using the current clinical guidelines,” says Patrick Carroll, M.D., chief medical officer of Hims & Hers. “For our weight loss offering, we follow the current recommendations for body mass index (BMI): Customers with a BMI of 30 and above (or 27 and above with certain comorbidities) are eligible for [our] GLP-1 [injectables].”

The $199 per month subscription to the Hims & Hers compounded injectable involves a close follow-up process and unlimited medical consultations with a licensed provider. The drug is not intended for diabetes management, according to Dr. Carroll.

To enhance safety standards, the company is partnering with an FDA-registered manufacturer for its 503B outsourcing facility, which is subject to state and federal oversight, he adds.

GLP-1 drugs are used in the treatment of type 2 diabetes, as well as overweight and obesity. The drugs trigger increased insulin production, which lowers an individual’s blood sugar to support metabolic health. At higher dosages, GLP-1 drugs can curb a user’s appetite and encourage feelings of satiation.

“It’s important to remember that obesity is a chronic disease, and managing its complications is a long game,” says Dr. Youdim, who adds waiting even six months to begin using semaglutide medications like Ozempic and Wegovy won’t significantly impact the long-term course of treatment. “My recommendation would be to wait [for FDA-approved drugs to become available] rather than use unapproved formulations,” she adds.