Hers is a telehealth platform, not a drug, so it isn’t something the FDA approves or disapproves. The real question is whether the products Hers sells carry FDA approval, and the answer depends entirely on which product you’re looking at. Some of the prescription medications available through Hers are fully FDA-approved. Others, particularly the compounded weight loss injections, are not.
Why a Telehealth Platform Can’t Be “FDA Approved”
The FDA approves specific drugs, medical devices, and certain biological products. It does not approve or certify telehealth companies, online pharmacies, or the platforms that connect patients with prescribers. Hers is a technology and healthcare company that facilitates consultations with licensed providers who can then prescribe medications. The platform itself falls outside the FDA’s approval framework entirely.
What matters to you as a consumer is the approval status of each individual product Hers delivers to your door. That status varies significantly across their product categories.
Prescription Medications That Are FDA-Approved
Several categories of standard prescription drugs available through Hers have full FDA approval. These include the same generic medications you’d pick up at a local pharmacy.
For anxiety and depression, Hers prescribes SSRIs and SNRIs like sertraline (Zoloft), escitalopram (Lexapro), fluoxetine (Prozac), and duloxetine (Cymbalta). All of these have been through the FDA’s full review process for safety, effectiveness, and quality. When you receive one of these through Hers, it’s the same FDA-approved generic drug available anywhere else.
For sexual health, Hers offers flibanserin, sold under the brand name Addyi. The FDA approved it in 2015 for premenopausal women with persistently low sexual desire that causes distress. It is not approved for postmenopausal women or for enhancing sexual performance.
For skincare, Hers prescribes tretinoin, the active ingredient in Retin-A. Tretinoin is FDA-approved for treating acne and has decades of clinical data behind it. However, Hers often delivers tretinoin blended into custom compounded formulations that combine multiple active ingredients. The individual ingredients may be FDA-approved on their own, but the specific combination in a compounded cream has not gone through the FDA’s premarket approval process.
Compounded Weight Loss Injections Are Not FDA-Approved
This is where things get more complicated, and it’s likely the reason many people are searching this question in the first place. Hers has marketed compounded versions of popular GLP-1 weight loss drugs. The brand-name versions of these medications (Ozempic, Wegovy) went through extensive clinical trials and earned FDA approval. The compounded versions Hers sells did not go through that same process.
The FDA has been direct about this distinction: “Compounded drugs are not approved by FDA. FDA-approved drugs go through FDA’s rigorous review for safety, effectiveness, and quality as part of the premarket approval process.” Compounded drugs use the same or similar active ingredients but are mixed by pharmacies rather than manufactured by the original drug company. They exist in a separate regulatory category with less oversight.
Compounding pharmacies have historically been allowed to make versions of drugs that are in shortage. But the FDA has clarified that as the national GLP-1 supply stabilizes, the legal basis for compounding these drugs narrows. Semaglutide and tirzepatide no longer appear on the FDA’s drug shortage list. Under federal law, compounders generally cannot make drugs that are “essentially a copy” of a commercially available product once the shortage is resolved.
This is an area of active legal and regulatory tension. The FDA considers a compounded drug essentially a copy if it contains the same active ingredient in the same or similar strength and can be used by the same route of administration as the commercially available version.
How Hers Pharmacies Are Regulated
Hers fulfills most prescriptions through its own pharmacies rather than third-party retailers. The company operates two pharmacies licensed under Section 503A of federal law and one outsourcing facility licensed under Section 503B. These two categories come with very different levels of federal oversight.
Section 503A pharmacies compound drugs based on individual prescriptions, much like a traditional compounding pharmacy. They follow state pharmacy regulations but are not inspected by the FDA and are not required to follow the same manufacturing standards (called cGMP) that large drug manufacturers must meet.
The Section 503B outsourcing facility faces stricter requirements. It must register with the FDA, follow cGMP manufacturing standards, report adverse events, and submit to regular FDA inspections. In December 2025, this facility received an FDA warning letter for failing to properly report an adverse event, a signal that the FDA is actively monitoring the operation.
Supplements Follow Different Rules Entirely
Hers also sells vitamins, supplements, and other over-the-counter wellness products. None of these are FDA-approved, but that’s true of all dietary supplements on the market, not just those from Hers. The FDA regulates supplements under a completely different framework than prescription drugs. Manufacturers are responsible for evaluating their own products’ safety and labeling before selling them. The FDA can take action against products that are adulterated or mislabeled, but it does not review or approve supplements before they reach store shelves.
What This Means in Practice
If you’re considering Hers for a standard prescription like an antidepressant or tretinoin, the active medication itself is FDA-approved and well studied. You’re getting the same drug you’d receive from any pharmacy, just ordered through a telehealth visit instead of an in-person appointment.
If you’re looking at Hers for compounded weight loss injections, the situation is fundamentally different. The active ingredient has been studied in its brand-name form, but the specific compounded product has not been reviewed by the FDA for safety, effectiveness, or manufacturing quality. The regulatory ground beneath these products is also shifting as the FDA tightens its policies on GLP-1 compounding now that drug shortages are easing.