Compounded Semaglutide Cost: Real Prices (2026)
What compounded semaglutide actually costs in 2026, how it compares to Wegovy and Ozempic, what the FDA says about compounded GLP-1 drugs, and how to evaluate telehealth GLP-1 programs.
Compounded semaglutide is a pharmacy-prepared medication sold through telehealth weight loss programs. In our September 2026 price checks, entry prices run from $99 to $199 per month, against $349 per month for brand-name Wegovy through NovoCare self-pay (after $199 per month for your first two fills if you are new to the offer) and a $1,349.02 original price listed on TrumpRx. Compounded drugs are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality. The FDA says compounded drugs should only be used when your medical needs cannot be met by an FDA-approved drug, and that a compounded drug might be appropriate when the approved drug is not commercially available. This guide covers what real programs charge in 2026, how compounded pricing compares to every branded route, and the specific questions to ask any program before you pay.
Verified Compounded Semaglutide Prices
Lowest verified price for compounded semaglutide on Sep 16, 2026: Eden at $99/mo, and Eden also lists a membership at $39 (intro price) or $99/mo.
| Provider | Product | Price | Includes | Checked | Evidence |
|---|---|---|---|---|---|
| Eden | Compounded Semaglutide | $99/mo | Medication | Sep 16, 2026 | Screenshot |
| HealthRx | Semaglutide | $99/mo on a 12-month plan | Medication, Consult | Sep 11, 2026 | Screenshot |
| Fridays | Compounded Semaglutide | $150/mo on a 4-month plan | Medication, Consult | Sep 11, 2026 | Screenshot |
| Shed | Compounded Semaglutide Injections | $159/mo on a 12-month plan | Medication | Sep 11, 2026 | Screenshot |
| Shed | Compounded Semaglutide Injections | $179/mo on a 6-month plan | Medication | Sep 11, 2026 | Screenshot |
| Medvi | MEDVi Semaglutide Program | $179/mo (intro price) | Medication, Consult | Sep 11, 2026 | Screenshot |
| Shed | Compounded Semaglutide Injections | $199/mo | Medication | Sep 11, 2026 | Screenshot |
- Eden also lists a membership: $39 (intro price) (screenshot); $99/mo (screenshot). Checked Sep 16, 2026.
- Medvi also lists a membership: $99 (screenshot). Checked Sep 11, 2026.
We load each provider's public pricing page, capture a cropped screenshot, and record only prices we can see next to the product name. A membership is shown as the provider lists it; check with the provider whether it applies to your plan. Prices change, so check the provider before you buy.
Price Ranges We Published Earlier
The programs below quote a monthly price for compounded semaglutide. Every compounded product listed is not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality. Here are the entry prices in our provider database as of September 11, 2026, alongside the branded comparison points:
| Provider | Monthly Cost | Per Dose | Consultation | Shipping | Notes |
|---|---|---|---|---|---|
| Strut Health | From $99/month | N/A (subscription) | Free online visit | Free | Compounded injectable semaglutide, not FDA-approved; free follow-up care, and your Strut doctor manages dose increases |
| HealthRx | $99/month (12-month plan); $133/month (3-month plan) | N/A (subscription) | Full refund if a provider does not approve you | Free | Compounded semaglutide, not FDA-approved; the lowest rate requires the 12-month plan |
| SkinnyRx | From $149.25/month | N/A (subscription) | Check at sign-up | Check at sign-up | Compounded injectable semaglutide, not FDA-approved; FDA-approved Wegovy also available |
| Shed | $159/month (12 months); $179 (6 months); $199 (1 month) | N/A (subscription) | Check at sign-up | Check at sign-up | Compounded semaglutide, not FDA-approved; the lowest rate requires a 12-month term; health coaching included |
| TrimRx | From $179/month | N/A (subscription) | Free consultation | Free tracked shipping | Compounded semaglutide, not FDA-approved; brand-name Ozempic and Wegovy also available |
| MEDVi | $179 first month | N/A (subscription) | Check at sign-up | Check at sign-up | Compounded semaglutide program; the MEDVi site says refills are locked in at $299; not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality |
| Sprout Health | From $199/month | N/A (subscription) | Check at sign-up | Check at sign-up | Compounded semaglutide and tirzepatide, not FDA-approved; ships from a US pharmacy in refrigerated packaging |
| Brand Wegovy (NovoCare self-pay) | $199 first two fills, then $349-$399/month | One box of 4 pens/month | Requires a prescription | Delivered by NovoCare Pharmacy; check at checkout | FDA-approved Wegovy pen: $199 for 0.25mg and 0.5mg on your first two fills if you are new to the offer (through December 31, 2026), then $349 for 0.25mg to 2.4mg and $399 for Wegovy HD 7.2mg. The Wegovy pill is $149 to $299 per month. Re-checked September 11, 2026; confirm at checkout. |
| Brand Wegovy (list price) | $1,349.02 original price (TrumpRx) | One box of 4 pens/month | Requires a prescription | N/A (pharmacy pickup) | With commercial insurance that covers Wegovy, the savings offer lets you pay as little as $25, subject to a maximum savings of $100/month |
Top Weight Loss Providers by Value
GLP-1 Weight Loss From $179/mo - Free 2-Minute Assessment
- Compounded GLP-1 (semaglutide) from $179/mo, GLP-1 + GIP (tirzepatide) from $259/mo
- Brand-name Ozempic®, Mounjaro®, Zepbound® and Wegovy® also available
- Free 2-minute qualification quiz and FREE doctor consultation - no cost, no obligation
- Free tracked shipping straight to your door after approval
First Month $179, Then $299/mo With No Membership Fee
- Doctor-guided GLP-1 care, 100% online - no waiting rooms
- Free dietician visits and care coaching included with your plan
- Doctor-formulated plans adjusted as your body responds
- Fast, discreet shipping to your door
Wegovy® From $149/mo Plus Membership From $74/mo - Free Insurance Check
- Full GLP-1 suite: Zepbound®, Wegovy® pill and pen, semaglutide and more
- Free insurance check shows what your plan covers before you pay
- Tirzepatide (Zepbound®) averaged up to 20.9% body weight loss in the 72-week SURMOUNT-1 trial; individual results vary
- On-demand provider coaching and support, 100% online
Detailed Price Breakdown by Provider
Strut Health and HealthRx
Strut Health and HealthRx share the low end of compounded semaglutide pricing at $99 per month. Strut includes a free online visit, free follow-up care and free shipping. HealthRx charges $99 per month on its 12-month plan and $133 per month on its 3-month plan, with free delivery and a full refund if a provider does not approve you. Both are compounded programs, not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality.
SkinnyRx and Shed
SkinnyRx lists compounded injectable semaglutide from $149.25 per month and also offers FDA-approved Wegovy. Shed lists compounded semaglutide at $159 per month on a 12-month term, $179 on a 6-month term and $199 month to month, with health coaching included. Compounded medications are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality. Read the plan length and cancellation terms before you commit to a longer term for the lower rate.
MEDVi and TrimRx
MEDVi and TrimRx both list $179 for compounded GLP-1 programs with provider oversight; compounded medications are not FDA-approved and are not reviewed by the FDA for safety, effectiveness, or quality. TrimRx lists compounded semaglutide from $179 per month with a free doctor consultation and free tracked shipping. MEDVi charges $179 for your first month with no contract, and the MEDVi site says refills are locked in at $299, so confirm the refill price and the dose escalation schedule before comparing against competitors.
Sprout Health
Sprout Health lists compounded semaglutide and tirzepatide from $199 per month, prescribed by US-licensed clinicians and shipped from a US pharmacy in refrigerated packaging. Compounded medications are not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality. Programs at this price compete on service depth: response time to messages, dose adjustment flexibility, and refill logistics.
Brand Wegovy via NovoCare
Novo Nordisk sells Wegovy directly for self-pay through NovoCare Pharmacy and delivers it to your door. The Wegovy pen costs $199 per month for 0.25mg and 0.5mg on your first two fills if you are new to the offer (through December 31, 2026), then $349 per month for 0.25mg, 0.5mg, 1mg, 1.7mg or 2.4mg and $399 per month for Wegovy HD 7.2mg. The Wegovy pill costs $149 per month for 1.5mg, $199 for 4mg, and $299 for 9mg and 25mg. Re-checked September 11, 2026; confirm current pricing at checkout, since manufacturer self-pay programs change. This is the FDA-approved product from the original manufacturer at roughly one-quarter of the $1,349.02 original price listed on TrumpRx, and it is the benchmark any compounded program has to beat on price to justify the tradeoffs.
Insurance and Compounded Semaglutide
Insurance matters here mostly indirectly. If your plan covers brand Wegovy, the savings offer lets you pay as little as $25 a month, subject to a maximum savings of $100 per month, and you get the FDA-approved product. If you have Medicare Part D, the Novo Nordisk Wegovy site says the Medicare GLP-1 Bridge makes the Wegovy pen and pill available at $50 per month from July 1, 2026 through December 31, 2027 if you are eligible, though that is not a guarantee of coverage. That makes checking coverage the first step before subscribing to anything compounded.
Commercial Insurance
Coverage: Check brand coverage first
If your plan covers Wegovy, the Wegovy savings offer lets you pay as little as $25 a month, subject to a maximum savings of $100 per month. Ask your plan whether it covers weight management and what prior authorization it requires.
Medicare / Medicaid
Coverage: Brand Wegovy $50/month via Medicare GLP-1 Bridge if eligible
The Novo Nordisk Wegovy site says the Medicare GLP-1 Bridge gives eligible Medicare Part D enrollees all dose strengths of the Wegovy pen and pill for $50 per month between July 1, 2026 and December 31, 2027, and that this is not a guarantee of coverage. It covers brand Wegovy, not compounded products. For Medicaid, check your state formulary.
HSA / FSA
Coverage: Check with your plan administrator
Ask your HSA or FSA administrator whether compounded semaglutide and program fees qualify before you pay with pre-tax funds, and request itemized receipts from your program for reimbursement.
Self-Pay
Coverage: N/A
Compounded semaglutide entry prices run $99 to $199 per month in our September 2026 checks, against $349 to $399 per month for NovoCare brand Wegovy after your first two fills and a $1,349.02 original price listed on TrumpRx. Compare the refill price, not only the first month: MEDVi, for example, charges $179 for the first month and says refills are locked in at $299.
Compounded vs Brand Semaglutide Options
There is no FDA-approved generic semaglutide. Your actual choice is between compounded preparations and the branded Novo Nordisk products. Only the branded products are FDA-approved: the FDA says it does not review compounded drugs for safety, effectiveness or quality before they are marketed, and it lists a claim that a compounded drug is the same as an FDA-approved drug as a telehealth red flag.
| Medication | Compounded/Generic | Brand-Name | Savings |
|---|---|---|---|
| Compounded semaglutide (telehealth programs) | $99-$199/month entry prices (September 2026); not FDA-approved | N/A | Varies by program; compare refill prices, not just the first month |
| Wegovy (weight management label) | No generic exists | NovoCare: pen $199 (first two fills), then $349-$399/month; pill $149-$299/month. TrumpRx original price $1,349.02 | The $349 NovoCare price is about 74% below the $1,349.02 original price |
| Ozempic (type 2 diabetes label) | No generic exists | As little as $25/month with commercial coverage (maximum savings $100/month); self-pay $349-$499/month after the first two fills | Insurance route for type 2 diabetes |
How to Save on Semaglutide
- Check brand coverage before subscribing to anything compounded: if your plan covers Wegovy, the savings offer lets you pay as little as $25 a month (maximum savings $100 per month), and you get the FDA-approved product.
- Compare compounded programs against the $349 NovoCare benchmark (re-checked September 11, 2026; confirm at checkout), not against the $1,349.02 original price: a $179 first month saves you $170 against $349, not about $1,170, and a $299 refill saves you $50.
- Confirm steady-state pricing: a first-month rate can sit below the refill price (MEDVi lists $179 for month one and $299 refills), and a higher dose can cost more. Ask for the full dose-price schedule in writing.
- Ask what happens to your protocol if compounding rules tighten further: programs with a transition path to branded product protect you from abrupt discontinuation.
- Ask your HSA or FSA administrator whether your prescribed GLP-1 program qualifies before you pay with pre-tax funds.
- Do not buy research-grade semaglutide from unregulated websites to save money. The FDA warns about fraudulent compounded semaglutide and tirzepatide with false label information, including labels that name compounding pharmacies that do not exist.
Hidden Costs and Risks to Watch For
- Dose and refill pricing: standard titration raises your dose over months, and a starting rate can rise with dose or after the first month. Ask for the full dose-price schedule in writing.
- Vial dosing errors: the FDA has received reports of dosing errors with compounded semaglutide in multiple-dose vials, in some cases five to 20 times the intended dose; confirm your program provides exact syringe instructions and unit markings for every dose change.
- Pharmacy sourcing opacity: legitimate programs name their partner pharmacy and its state license; treat refusal to identify the pharmacy as disqualifying.
- Cancellation terms: check the notice period and any restart fee before you subscribe.
- Lab work and follow-up visits billed separately at some programs; ask what they cost before you sign up.
- Regulatory risk: the FDA says compounded drugs should only be used when your medical needs cannot be met by an FDA-approved drug, and the rules could tighten further; a program with no branded fallback leaves you managing an abrupt stop alone.
Frequently Asked Questions
How much does compounded semaglutide cost per month?
Telehealth compounded semaglutide programs list entry prices from $99 to $199 per month in our provider database as of September 11, 2026; compounded medications are not FDA-approved and are not reviewed by the FDA for safety, effectiveness, or quality. Strut Health and HealthRx start at $99 (HealthRx on its 12-month plan; $133 on its 3-month plan), SkinnyRx at $149.25, Shed at $159 on a 12-month term, TrimRx and MEDVi at $179 (MEDVi for your first month; its site says refills are locked in at $299), and Sprout Health at $199. Two pricing realities to check before subscribing: first, an advertised rate can depend on plan term (the lowest HealthRx and Shed rates require 12-month plans), and titration can raise your dose and sometimes your price; second, the first month can be priced lower than the refills. The benchmark to compare against is brand-name Wegovy through NovoCare Pharmacy, the manufacturer self-pay channel: $349 per month for 0.25mg to 2.4mg and $399 for Wegovy HD 7.2mg, after $199 per month for your first two fills if you are new to the offer (through December 31, 2026). Re-checked September 11, 2026; confirm current pricing at checkout. A $179 compounded month saves you $170 against the $349 NovoCare price, which is real but far smaller than a comparison against the $1,349.02 original price suggests.
Is compounded semaglutide legal in 2026?
It can be, but compounded semaglutide is not FDA-approved. The FDA says compounded drugs should only be used when your medical needs cannot be met by an FDA-approved drug, and that a compounded drug might be appropriate when the FDA-approved drug is not commercially available. The FDA also lists warning signs for telehealth programs, including claims that a compounded drug is the same as an FDA-approved drug, prices that seem too good to be true, no screening and prescription by a licensed doctor, and no licensed doctor available to answer questions after you receive your medication. The practical questions for you are whether a licensed US prescriber evaluates you individually, whether the program names its state-licensed pharmacy, and whether a licensed doctor is available once treatment starts.
Is compounded semaglutide as effective as Wegovy?
Nobody can tell you that with trial evidence, because compounded semaglutide has not been studied the way Wegovy was. The 14.9% average body weight loss over 68 weeks in the STEP 1 trial (individual results vary), published in the New England Journal of Medicine, was measured on semaglutide 2.4mg made by Novo Nordisk, not on compounded products, and compounded drugs are not FDA-approved: the FDA does not review them for safety, effectiveness or quality before they are marketed. Brand Wegovy comes in fixed-dose pens made under FDA manufacturing oversight; compounded semaglutide depends on the individual pharmacy preparing it accurately. The FDA has also received reports of dosing errors with compounded semaglutide in multiple-dose vials, in some cases five to 20 times the intended dose. If you and your provider consider a compounded program, ask it to name its licensed pharmacy and give you precise administration instructions.
Why is compounded semaglutide so much cheaper than Wegovy?
Because you are paying for different things. Brand Wegovy is an FDA-approved product made by Novo Nordisk in prefilled pens, while compounded semaglutide, which is not FDA-approved, is prepared by pharmacies, dispensed in multiple-dose vials or prefilled syringes according to the FDA, and sold through telehealth programs. The gap is smaller than list prices suggest. Against the $1,349.02 original price listed on TrumpRx, compounded entry prices look over $1,000 cheaper, but Novo Nordisk sells Wegovy self-pay through NovoCare at $349 per month for 0.25mg to 2.4mg and $399 for Wegovy HD 7.2mg (re-checked September 11, 2026). Against that, compounded entry prices of $99 to $199 save you $150 to $250 a month, and a $299 refill saves you $50. That is why the smarter comparison for your budget is compounded versus NovoCare, and why programs priced near $300 face a hard question about what you are getting for near-brand money.
What should I ask before starting a compounded semaglutide program?
Compounded semaglutide is not FDA-approved, and five questions filter the field quickly. First, which licensed US pharmacy fills the prescription, and in which state? Legitimate programs answer immediately; evasion is disqualifying. Second, what is the full dose-price schedule through month six, including escalation, so the advertised starting price cannot surprise you later. Third, what exact administration instructions and syringe guidance come with each dose change, given documented FDA reports of multi-fold dosing errors with compounded vials. Fourth, what happens to your treatment if compounding rules tighten again, and whether the program offers a transition path to branded product like NovoCare Wegovy at $349-$399 per month (re-checked September 11, 2026). Fifth, who evaluates you clinically, at intake and ongoing, and how fast the provider responds when you report side effects. Any program that answers all five cleanly is treating you as someone in its care; a program that stumbles on most of them is treating you as a subscription.
Can I use HSA or FSA funds for compounded semaglutide?
Possibly, but confirm with your HSA or FSA plan administrator before you pay, because eligibility for compounded medication, which is not FDA-approved, and for program fees can vary by plan. If you pay out of pocket, keep an itemized receipt showing the prescription, the provider, and the amounts so you can submit it for reimbursement.
What is the cheapest compounded semaglutide program?
In our provider database as of September 11, 2026, Strut Health and HealthRx share the low end at $99 per month (HealthRx on its 12-month plan; $133 on its 3-month plan), followed by SkinnyRx at $149.25, Shed at $159 on a 12-month term, TrimRx and MEDVi at $179 (MEDVi for your first month; its site says refills are locked in at $299), and Sprout Health at $199; all are compounded programs, not FDA-approved and not reviewed by the FDA for safety, effectiveness, or quality. Before choosing purely on the headline number, verify three things that change the real ranking. First, the steady-state price after the first month and after dose escalation, because programs differ in how much refills and higher doses cost. Second, what the subscription actually includes: a low monthly rate that bills labs and follow-ups separately can end up costing more than it looks. Third, plan length, refill flexibility and cancellation terms, since the lowest rates at HealthRx and Shed require a 12-month plan. The cheapest program is the one with the lowest six-month total for your dose, not the lowest first-month banner price.
Why do compounded semaglutide prices vary so much between programs?
Prices span $99 to $199 at entry, and more after the first month at some programs, for a few reasons: which compounding pharmacy the program contracts with; how much clinical service is bundled, from bare prescription renewal up to responsive providers, dose management, and side effect support; plan length, since HealthRx and Shed charge less per month on a 12-month plan; and dose, since some programs price higher doses above the starting rate. What price does not reliably signal is medication quality. A $99 program and a $199 program may use equally reputable pharmacies, and a mid-priced program may use a weaker one. None of these compounded products is FDA-approved, so judge quality directly: ask which licensed US pharmacy fills the prescription, confirm its state license, and evaluate how the program handled your intake questions. Pay more only for service you will actually use, not for the assumption that expensive means safer.
How much does a year of compounded semaglutide cost?
Annual totals at 12 monthly payments of the entry price, before any dose-based price changes: $1,188 at Strut Health or HealthRx on its 12-month plan ($99/month), $1,791 at SkinnyRx ($149.25/month), $1,908 at Shed on a 12-month term ($159/month), $2,148 at TrimRx ($179/month), $2,388 at Sprout Health ($199/month), and $3,468 at MEDVi ($179 for the first month, then 11 refills at the $299 its site lists). All of these are compounded programs; compounded medications are not FDA-approved and are not reviewed by the FDA for safety, effectiveness, or quality. The branded comparison: Novo Nordisk defines a Wegovy month as one box of 4 weekly pens, so a year of treatment takes 13 boxes. At the $349 NovoCare price that is $4,537 a year ($4,237 if your first two fills are at $199), and $5,187 at the $399 Wegovy HD price. Covered commercial insurance with the savings offer can cost as little as $25 per box. Two things belong in an honest annual budget. First, monitoring: ask whether your program bills labs or follow-up visits separately. Second, duration: the STEP 1 extension study reported that participants regained much of their lost weight within a year of stopping semaglutide, so budget for the possibility of multi-year treatment if you and your provider continue it, and compare on that basis against the branded routes or intensive lifestyle programs, not as a single-year expense that simply ends.
Is oral compounded semaglutide cheaper than injectable?
We have no verified prices for oral or sublingual compounded semaglutide in our September 2026 checks, so we cannot tell you it is cheaper. For an FDA-approved oral option, the Wegovy pill costs $149 per month for 1.5mg, $199 for 4mg and $299 for 9mg and 25mg through NovoCare. The clinical tradeoff matters more than the price difference. Oral semaglutide absorbs far less efficiently than injection: FDA-approved oral semaglutide such as Rybelsus (approved for type 2 diabetes) uses a specialized absorption enhancer and still delivers a small fraction of an injected dose, and compounded sublingual drops and troches, which are not FDA-approved, lack the absorption data behind the approved tablets. Published weight loss evidence, including the 14.9% STEP 1 result, comes overwhelmingly from once-weekly subcutaneous injection. If needle aversion is the obstacle, ask your provider to compare the FDA-approved Wegovy pill and an injectable before you consider a compounded sublingual with limited evidence, and weigh the evidence gap more heavily than a small monthly price difference.
Sources & References
Our comparisons are informed by official sources and regulatory guidelines. We encourage readers to verify information with authoritative sources.
- FDA Drug InformationGLP-1 medication approvals and safety
- NIH National Institute of DiabetesWeight management research
- CDC Obesity InformationObesity statistics and health impacts
- Obesity Medicine AssociationClinical obesity treatment guidelines
Editorial Note: Researched and edited by our editorial team. AI tools assist with initial research and drafting; all content is fact-checked and edited by humans before publication. Learn more about our editorial standards
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Disclaimer: Pricing information is based on publicly available data and may change without notice. Actual costs depend on your specific treatment plan, insurance coverage, and provider. Always verify current pricing with providers before purchasing. This article is for informational purposes only and is not financial or medical advice. We may receive compensation through affiliate links, which helps support our research.
Regulatory noticeRegulatory note (verified August 22, 2026): On February 20, 2026 the FDA issued MEDVi, LLC a warning letter (MARCS-CMS 721455) citing misbranding under sections 502(a) and 502(bb) of the FD&C Act. Reviewing medvi.io in December 2025, the FDA said labels bearing "MEDVi" implied MEDVi compounds the drugs when it does not, and that "Same active ingredient as Wegovy and Ozempic" and "Same active ingredient as Mounjaro and Zepbound" implied an FDA approval compounded drugs do not have. We found no close-out letter, so the matter appears open. MEDVi states medvi.io is affiliate-operated rather than company-operated; we could not verify that, and the letter is addressed to MEDVi, LLC. Read the FDA letter
Regulatory noticeRegulatory note (verified August 22, 2026): The FDA reviewed struthealth.com in December 2025 and, on February 20, 2026, issued Strut Health, LLC a warning letter, MARCS-CMS 721448. It raises two separate problems. Pictured product labels carry the "Strut" name, which the agency said represents Strut as the compounder of the semaglutide and tirzepatide products when it is not. Three site claims are also quoted, among them "Generic Zepbound, Mounjaro" and "Semaglutide is the active ingredient in the brand medications." Because compounded drugs hold no FDA approval, the FDA said wording of that kind implies one, and it cited misbranding under sections 502(a) and 502(bb) of the FD&C Act. FDA’s warning letter index shows no response letter and no close-out letter, so we treat the matter as open. Read the FDA letter
Regulatory noticeRegulatory note (verified August 22, 2026): Eden Health International Inc. was sent FDA warning letter MARCS-CMS 728279 on June 8, 2026, following an agency review of tryeden.com in March 2026. The letter lists two findings. The first is the "Eden" name on pictured labels for compounded semaglutide and tirzepatide, which the FDA said represents Eden as the compounder when it is not. The second is the site’s description of its sourcing as "FDA-licensed 503(a) outsourcing facilities," a designation the agency says does not exist, because the FD&C Act creates no FDA approval or license for pharmacies or outsourcing facilities. Both were cited as misbranding under sections 502(a) and 502(bb). FDA has posted no close-out letter, so the matter reads as open. Read the FDA letter
Verification limitationVerification note (checked August 23, 2026): we could not identify the legal entity behind HealthRx through public records. Its website does not name an operating company, its domain registration is privacy-shielded, and we could not confirm a listing in any business registry or accreditation database we checked. This is not a finding of wrongdoing. It means our usual checks, including our search of FDA enforcement records, could only be run against the brand name and domain rather than a confirmed company.
Regulatory noticeRegulatory note (verified August 22, 2026): One sentence is all that FDA warning letter MARCS-CMS 715879 quotes. Sent to Sprout Health Partners LLC on September 9, 2025 after an August 2025 review of joinsprouthealth.com, it cites the line "GLP-1 medications are FDA-approved and backed by extensive clinical research..." Appearing on pages offering compounded semaglutide and tirzepatide, that statement implied to the agency that the compounded products themselves are FDA-approved, which they are not, and it was cited as misbranding under FD&C Act 502(a) and 502(bb). A search of FDA’s warning letter index turns up no close-out letter, so the matter appears open. Read the FDA letter
Regulatory noticeRegulatory note (verified August 22, 2026): Skinny.Rx operates as SkinnyRx, but the legal entity is Lean Rx, Inc., and that is the name on FDA warning letter MARCS-CMS 717989, dated February 20, 2026. Following a December 2025 review of skinnyrx.com, the agency objected to the "SkinnyRx" name on pictured labels, saying it implies SkinnyRx compounds the drugs itself, and to three marketing lines, including "Get access to the same active ingredient as name-brand GLP-1 medications" and "It contains the same active ingredient as FDA-approved medications." Compounded semaglutide and tirzepatide are not FDA-approved, so the FDA read those lines as implying an approval that does not exist and classed the products as misbranded. No close-out letter is posted; read the matter as unresolved. Read the FDA letter
Regulatory noticeRegulatory note (verified August 22, 2026): Hers is a brand of Hims & Hers Health, Inc., and the FDA wrote to that company twice on September 9, 2025, once for each brand. The Hers letter, MARCS-CMS 716825, went to chief executive Andrew Dudum after an August 2025 review of forhers.com. It quotes two claims made for compounded semaglutide: "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." The agency’s position is that compounded products carry no FDA approval, so claims like these imply a sameness with approved medicines that has not been established, making the products misbranded. FDA’s index lists neither a response nor a close-out letter, so the matter stands open. Read the FDA letter
Regulatory noticeRegulatory note (verified August 22, 2026): On September 9, 2025 the FDA sent Hims & Hers Health, Inc. a warning letter covering the Hims brand, MARCS-CMS 716567, drawn from a review of hims.com the previous month. Two lines about compounded semaglutide are quoted in it: "Same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients." Compounded drug products are not FDA-approved, and the agency said phrasing of this sort suggests otherwise, which is what makes the products misbranded under FD&C Act sections 502(a) and 502(bb). A companion letter went to the same company that day for its Hers brand. No close-out letter appears in FDA’s index; treat this as open. Read the FDA letter