FDA's warning to telehealth companies on compounded drugs: what to check
The FDA's position is clear: compounded drugs, including compounded hormones, are not FDA-approved, and the agency does not review them for safety, effectiveness or quality before they reach you. In guidance written specifically for telehealth companies, FDA cautions against marketing that suggests a compounded drug is FDA-approved or the same as an approved brand-name product. That does not make compounding wrong. It means that before you start testosterone or hormone therapy online, you should check two things: what the provider claims, and which pharmacy actually makes your medication.
If you are comparing the top telehealth testosterone replacement therapy providers in 2026, whether that is Hims, Ro, Hone Health, a menopause platform, or a smaller physician practice, the checks below apply to all of them. Ratings sites rank clinics on price and convenience. This guide ranks the questions that protect you.
What FDA tells telehealth companies about promoting compounded drugs
FDA published a page called Telehealth Companies: What to Know When Promoting Compounded Drugs. Its audience is the companies, not patients, but the message translates directly into what you should watch for.
The core points, in plain English:
- Compounded drugs are not FDA-approved. Marketing should not suggest otherwise, whether by saying so directly or by implication.
- A compounded drug is not the same as an approved brand. Calling a compounded product a generic or equivalent version of an FDA-approved drug can mislead patients, because it has not gone through the approval process that brand and generic drugs go through.
- Claims about safety and effectiveness need to be truthful and not misleading. Borrowing results from studies of an approved product and applying them to a compounded version is the kind of messaging FDA is concerned about.
The reason FDA addressed telehealth by name is scale. A single online brand can reach patients in dozens of states with polished ads, and the person reading those ads usually cannot see which pharmacy is behind the product.
Why compounded drugs are not reviewed before you get them
FDA's page on understanding the risks of compounded drugs explains the gap. An FDA-approved drug goes through agency review of its safety, effectiveness and manufacturing quality before it is sold. A compounded drug does not. FDA states that it does not review compounded drugs to evaluate their safety, effectiveness or quality before they reach patients.
That has practical consequences for you:
- Strength can vary. Without premarket review, the protection against a batch being too strong or too weak comes from the pharmacy's own quality systems and its regulators, not from an FDA approval.
- Sterility matters for injections. Injectable hormones and peptides must be sterile. Poor compounding practices can lead to contamination, which is why FDA's risk page emphasizes quality.
- There is no approved label. FDA-approved testosterone products come with labeling that lists approved uses, warnings and side effects. FDA's testosterone information page is a good starting point: it explains that testosterone products are approved for men with low testosterone caused by certain medical conditions and covers the safety issues the agency has reviewed. A compounded product does not carry that approved labeling.
None of this means compounded medication is unsafe by default. It means the safety rests on the prescriber and the pharmacy, so those are what you evaluate.
When compounding is the right call
Compounding exists for good reasons. FDA's own risk page acknowledges that a compounded drug can serve patients whose medical needs cannot be met by an FDA-approved drug. Common, legitimate situations include:
| Situation | Why compounding can help |
|---|---|
| Allergy or sensitivity to an ingredient | A pharmacy can make a version without a dye, preservative or filler you react to |
| A dose that is not commercially available | Your clinician may need a strength between or below standard products |
| A form you can actually use | A cream, liquid or different delivery format when the approved version does not work for you |
| An approved product is unavailable | Shortages or discontinued products can leave no approved option at the moment |
The common thread is a reason tied to you as a patient. A reasonable clinic can tell you why a compounded product was chosen over an FDA-approved one. Many hormones used in optimization, such as testosterone cypionate and estradiol patches, also exist as FDA-approved products, so it is fair to ask which version you are getting and why.
For a deeper look at how compounding pharmacies differ from traditional ones, read our guide to compound vs traditional pharmacies.
Five claims to question in telehealth hormone ads
When you scroll through the best online hormone therapy providers for TRT or HRT, these five claims deserve a second look. Each one conflicts with what FDA has said about compounded drugs or with how hormone therapy actually works.
| Claim in the ad | Why it is a red flag | What a careful provider says instead |
|---|---|---|
| "FDA-approved" compounded testosterone or estradiol | Compounded drugs are not FDA-approved, per FDA | "Prescribed by a physician and filled by a licensed compounding pharmacy" |
| "Same as" or "generic" version of a brand | FDA cautions that compounded drugs are not equivalent to approved products | Names whether you are getting an approved product or a compounded one |
| "Clinically proven" with brand trial results | Trials of an approved drug did not test that compounded product | Cites the evidence honestly and notes its limits |
| Guaranteed levels or results | Response to hormone therapy varies by person; no clinic can promise a number | Sets goals after labs and adjusts based on follow up testing |
| "No labs needed" or "bioidentical, so no risk" | Hormone therapy needs baseline and ongoing monitoring; "bioidentical" does not mean risk free, and approved bioidentical products also exist | Requires blood work before prescribing and during treatment |
One more pattern to notice: an "FDA-approved pharmacy." FDA does not approve pharmacies. Traditional compounding pharmacies are licensed by state boards of pharmacy, and outsourcing facilities register with FDA. If a clinic uses the word "approved" for its pharmacy, ask what it actually means.
Questions to ask about the pharmacy: 503A vs 503B, license and testing
The pharmacy is the part of a telehealth hormone replacement therapy provider you never see. Ask about it directly. A good provider will answer without hesitation.
| 503A compounding pharmacy | 503B outsourcing facility | |
|---|---|---|
| What it does | Compounds medication for an individual patient's prescription | Can compound larger batches, with or without individual prescriptions |
| Main oversight | State board of pharmacy | Registered with FDA and subject to federal manufacturing quality standards and FDA inspection |
| What to ask | Is it licensed in my state? How are sterile products tested? | Is it registered with FDA? What do recent inspections show? |
Your short list of questions:
- Is this an FDA-approved product or a compounded one? If compounded, why?
- Is the pharmacy a 503A pharmacy or a 503B outsourcing facility?
- Is it licensed in my state? Pharmacies generally need a license to ship into the state where you live.
- For injections, how is sterility tested? Ask whether batches are tested for sterility and potency, and whether you can see a certificate of analysis.
- Who do I call if something seems off? You should have a clinical contact for side effects and a clear process for reporting a problem.
You can also report suspected problems with any drug, compounded or approved, to FDA's MedWatch program, which FDA references on its compounding pages.
How to use this when comparing telehealth TRT and HRT providers
Most lists of top telehealth testosterone providers compare price and speed. Those matter, but the FDA's guidance points to criteria that matter more:
- Medical evaluation first. A real consultation and lab panel before any prescription.
- Honest language. No "FDA-approved" or "same as" claims for compounded products.
- Pharmacy transparency. The clinic tells you who fills your medication and how it is regulated.
- Ongoing monitoring. Follow up labs and clinician access, not just refills.
- Clear pricing structure. Whether consults, labs and medication are bundled or billed separately, and whether the clinic takes insurance or is cash pay. Check each company's own pricing page for current numbers, since they change.
Here is where BioCure Health fits. BioCure is a physician-led telehealth longevity clinic based in the Fort Lauderdale area, licensed to treat patients in 47 states, with appointments by video or in person. Every protocol starts with a physician video consultation ($199, which can be credited back with a membership), followed by diagnostics through an at-home kit with an in-home phlebotomist or in-lab testing. Results come back in 7 to 14 days and are reviewed with you one on one before anything is prescribed. Custom protocols are filled through licensed compounding pharmacy partners and ship to your door, with follow up included. You are welcome to ask us every pharmacy question on the list above.
For men, our testosterone therapy program has three tiers: bioOptimize (foundational), bioRestore (medications that support your body's own testosterone production without direct replacement), and bioTest (full replacement with ongoing hormone monitoring). Women's hormone care, including progesterone cream and estradiol patches, follows the same evaluation first approach. BioCure does not accept insurance directly; many patients use HSA or FSA funds, and we provide documentation for reimbursement.
BioCure is a strong fit if you want a physician to read your labs with you and explain each choice. If your priority is insurance billing, a provider that bills insurance directly may suit you better.
Frequently asked questions
Are compounded hormones FDA-approved?
No. FDA states that compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness or quality before they reach patients. That applies to compounded testosterone, estradiol and progesterone. Some hormones are also available as FDA-approved products, so ask which version you are prescribed.
Is compounded testosterone safe?
It can be appropriate when prescribed after a proper evaluation and made by a well regulated pharmacy, but its safety depends on the prescriber and pharmacy rather than an FDA approval. Ask whether the pharmacy is 503A or 503B, whether it is licensed in your state, and how injectable batches are tested for sterility and potency. Ongoing lab monitoring is part of using any testosterone safely.
What did the FDA say about telehealth companies and compounded drugs?
FDA published guidance for telehealth companies on promoting compounded drugs. It cautions against marketing that implies a compounded drug is FDA-approved or the same as an approved brand, and expects claims about safety and effectiveness to be truthful and not misleading. For patients, it is a useful checklist for reading telehealth ads.
What is the difference between a 503A and 503B pharmacy?
A 503A pharmacy compounds medication for individual patient prescriptions and is overseen mainly by state boards of pharmacy. A 503B outsourcing facility registers with FDA, can make larger batches, and is subject to federal manufacturing quality standards and FDA inspection. Either can be legitimate; what matters is that the pharmacy is properly licensed and tests what it makes.
How do I choose a legit online TRT provider?
Look for a physician consultation and blood work before any prescription, honest language about compounded products, transparency about the pharmacy, and follow up labs during treatment. Avoid providers that guarantee results or skip lab testing. Compare how each one prices its service, and check their official pricing pages for current figures.
Does BioCure use compounded medications?
BioCure builds custom protocols that are filled through licensed compounding pharmacy partners, after a physician consultation and lab testing. Your physician explains what is prescribed and why during a one on one results review. You can ask about the pharmacy that fills your medication at any point.
The smartest thing you can do before starting hormone therapy online is ask better questions than the ads answer. Longevity is not accidental, it is intentional, and that starts with knowing exactly what you are putting in your body and who made it.
Let BioCure Health lead you in the right direction. Call or text us to schedule an introductory call at 754-206-0838. Your future self will thank you.