Compounded semaglutide is semaglutide prepared by a compounding pharmacy for an individual prescription, rather than manufactured by Novo Nordisk under an FDA approval.
What you are getting
A compounding pharmacy mixes semaglutide into vials, or sometimes tablets or drops, for a named patient. The product is not Wegovy or Ozempic, is not FDA-approved, and has not been through FDA review [1]. FDA has repeatedly cited telehealth companies for describing compounded semaglutide as having the "same active ingredient as Ozempic and Wegovy," because that implies FDA review it never had [5] [6].
Three ingredient issues FDA has flagged:
- Salt forms. Semaglutide sodium and semaglutide acetate are different active ingredients from the approved drugs, and FDA knows of no lawful basis to compound with them [1].
- Add-ins. FDA's Sept 18, 2026 letter to Empower Pharmacy called its semaglutide-with-cyanocobalamin (vitamin B12) products "essentially copies" of the approved drug [7].
- Bulk sources. Since Sept 5, 2025, GLP-1 ingredients from plants not on FDA's green list can be detained at the border [8].
Legal status, step by step
| Date | Event | Source |
|---|---|---|
| Feb 21, 2025 | FDA declares the semaglutide injection shortage resolved for all presentations | [2] |
| April 24, 2025 | Tolerance for 503A pharmacy compounding ends when a court denies an injunction | [2] |
| May 22, 2025 | Tolerance for 503B outsourcing facilities ends | [2] |
| Sept 9, 2025 | FDA warning letters to Hims, Hers and other telehealth firms over compounded semaglutide claims | [5] [9] |
| Feb 6, 2026 | FDA says it will restrict GLP-1 ingredients used in non-approved compounded drugs, naming Hims & Hers | [10] |
| March 3, 2026 | 30 more telehealth warning letters announced | [11] |
| March 9, 2026 | Hims & Hers and Novo Nordisk announce Hims will offer brand Wegovy and Ozempic and stop most marketing of compounded GLP-1s | [12] |
| April 1, 2026 | FDA restates 503A and 503B limits | [2] |
| June 8, 2026 | 25 more telehealth warning letters | [13] |
| Aug 27, 2026 | Fifth Circuit upholds FDA (No. 25-10758, semaglutide) | [14] |
| Sept 18, 2026 | Warning letter to Empower Pharmacy over semaglutide blends | [7] |
What the law allows today
A 503A pharmacy may compound semaglutide for an individual patient's prescription. It may not make copies of an approved drug unless the prescriber decides and documents that a change makes a significant difference for that patient. FDA says it will not act against a pharmacy filling four or fewer copy prescriptions a month, but may act against unsafe or substandard products. A 503B outsourcing facility cannot compound semaglutide from bulk at all [2].
Will it be banned?
It is already restricted rather than banned outright. FDA has said it intends to take action against non-approved GLP-1 ingredients and warned of seizures and injunctions "without further notice" [10]. No end date has been announced. Watch our FDA warning letter tracker.
Safety: what FDA has seen
- 990 adverse event reports for compounded semaglutide as of May 31, 2026, likely an undercount because 503A pharmacies do not have to report [1].
- Dosing errors. FDA has reports, some needing hospital care, from patients mismeasuring doses from vials and clinicians miscalculating them; some patients were prescribed doses higher than the label or raised doses faster than labeled [1].
- Counterfeits. FDA warns of counterfeit Ozempic in the US [1], and the Justice Department charged two people on Sept 29, 2026 over a counterfeit Ozempic scheme [15].
Does it work?
We found no trial of compounded semaglutide products in the sources we reviewed, so how well a given vial works is unknown. Brand Wegovy 2.4 mg averaged 14.9% weight loss at 68 weeks in STEP 1 [16]; that result belongs to the approved product. FDA bars sellers from claiming compounded drugs are clinically proven to give the same result [6].
Pills and drops
FDA's main page on unapproved GLP-1s does not address oral compounded semaglutide [1]. The ad watchdog NAD found Willow's claims for compounded semaglutide tablets unsubstantiated; Willow refused to comply and NAD referred it to regulators [17]. The FDA-approved oral option is the Wegovy pill, $149 to $299 a month [18].
Handling, storage and how long it lasts
We do not give doses or mixing steps for compounded vials. Units depend on the concentration printed on your pharmacy label; follow your prescriber and that label, and ask the pharmacist about anything unclear. For reference, brand Wegovy starts at 0.25 mg weekly for 4 weeks and steps up every 4 weeks to 1.7 or 2.4 mg, with 7.2 mg the label maximum for adults [19].
- After 28 days: FDA says to discard compounded multi-dose vials 28 days after first use [1].
- Needles: new sterile needle and syringe for each dose [1].
- Warm on arrival: do not use it [1].
- Refrigeration: follow the pharmacy label. The 28-day room-temperature allowance in the Wegovy label applies to brand pens only [20]. More on semaglutide storage.
- Where to inject: the Wegovy label lists the abdomen, thigh or upper arm, rotating sites [19].
- How long it stays in your system: the Wegovy label says to stop at least 2 months before a planned pregnancy because semaglutide has a long half-life [19].
Prices, checked Oct 17, 2026
| Program (verdict) | Price | Terms | Source |
|---|---|---|---|
| IVIM (caution) | $65 a month | 12-month program; waitlist note; $75 membership | [3] |
| OrderlyMeds (caution) | $74 intro, then $149 a month | Same price every dose | [21] |
| Eden (caution) | $99 a month | Headline price | [22] |
| bmiMD (clean) | As low as $119 a month | Plan length not shown | [23] |
| Found (clean) | $169 to $289 per 28 days | Visits included; labs extra | [24] |
| FancyMeds (caution) | $249 per 4 weeks at 0.25 mg | One-time purchase | [25] |
| Direct Meds (caution) | $297 a month | Visit, supplies, shipping | [4] |
We may earn a commission if you sign up through some links on this page. It never changes a verdict. How we make money
Compounded semaglutide programs (clean or caution)
- Clean
- Price
- Compounded semaglutide plan, medication included, per 28 days in cash: $289 (1-month plan), $249 (3-month), $219 (6-month), $169 (12-month). First month on the 1-month plan $179. Checked Oct 17, 2026 [24].
- What you get
- Compounded semaglutide and tirzepatide, brand GLP-1s, and non-GLP-1 drugs. Accepts insurance for visits.
- FDA record
- No FDA warning letter found as of Oct 17, 2026.
- BBB
- BBB profile not checked as of Oct 17, 2026.
- Note
- Billing every 28 days means 13 charges a year. Labs are extra. Membership is refundable only within 3 days or before the first consult. Verdict: clean (provisional). Found review
- Clean
- Price
- Compounded semaglutide "as low as $119/mo"; plan length not shown. Checked Oct 17, 2026 [23].
- What you get
- Compounded semaglutide and tirzepatide, including microdose plans. Pharmacy not named.
- FDA record
- No FDA warning letter found as of Oct 17, 2026.
- BBB
- BBB profile not checked as of Oct 17, 2026.
- Note
- Refund policy page could not be read. Trustpilot reviewers report warm deliveries and repeat charges. Verdict: clean (provisional). bmiMD review
- Use caution
- Price
- Compounded semaglutide $74 a month as a new-customer intro ($149 for 2 months), then $149 a month; a 2-month offer is $224. Same price at every dose. Checked Oct 17, 2026 [21].
- What you get
- Compounded semaglutide and tirzepatide from named 503A pharmacies (SmartPharmaRx, Casa, PerfectRx), plus brand drugs at list-level prices.
- FDA record
- FDA warning letter dated June 8, 2026 [26] for its logo on compounded vial labels and an "FDA-licensed pharmacy" claim. That claim was gone from the main pages on Oct 17, 2026; vial images were not confirmed.
- BBB
- BBB profile not checked as of Oct 17, 2026.
- Note
- Trustpilot average 3.5, with warm deliveries and refused refunds among complaints. The price doubles after the intro. Verdict: caution (provisional). OrderlyMeds review
- Use caution
- Price
- Compounded semaglutide $99 a month headline price, "same price at every dose" with exceptions. Checked Oct 17, 2026 [22].
- What you get
- Compounded semaglutide, brand GLP-1s and other compounded products.
- FDA record
- FDA warning letter dated June 8, 2026 [27] for "Eden" on vial labels and an "FDA-licensed" pharmacy claim. The text claim was gone on Oct 17, 2026; GLP-1 vial images were not confirmed.
- BBB
- BBB profile not checked as of Oct 17, 2026.
- Note
- Refund policy not linked from the pages we read. Verdict: caution (provisional). Eden review
- Use caution
- Price
- Compounded semaglutide $297 a month including the physician visit, supplies and shipping; no contract. Checked Oct 17, 2026 [4].
- What you get
- Compounded semaglutide and tirzepatide; pharmacy not named.
- FDA record
- FDA warning letter dated Sept 9, 2025 [28] for "same active ingredient" claims. Those phrases were not on its home or pricing page on Oct 17, 2026.
- BBB
- BBB profile not checked as of Oct 17, 2026.
- Note
- Dose tiers are not shown. Verdict: caution (provisional). Direct Meds review
FancyMeds
Use caution- Price
- Compounded semaglutide at 0.25 mg a week: $249 per 4 weeks standard, promo from $108.99. Checked Oct 17, 2026 [25].
- What you get
- One-time purchases of compounded semaglutide and tirzepatide; no membership and no auto-renew.
- FDA record
- FDA warning letter dated Sept 9, 2025 [29] for "same active ingredient" and "FDA-monitored" claims. The site now says compounded drugs are not FDA-approved.
- BBB
- BBB profile not checked as of Oct 17, 2026.
- Note
- Full refund before shipment, none after. Pharmacy not named. Verdict: caution (provisional).
Compounded semaglutide sellers we rate avoid
- MedVi: BBB rating F with 751 complaints, 135 unanswered [30]; FDA warning letter dated Feb 20, 2026 [31]. Read our MedVi review
- TrimRx: BBB rating F and a BBB "pattern of complaints" alert: 2,598 complaints in 3 years about billing and cancellations [32]. Read our TrimRx review
- Fridays: BBB rating F; 65 complaints in the last 12 months, 63 unanswered, mostly billing and refunds [33]. Read our Fridays review
- Shed (ShedRx): 257 BBB complaints in 3 years about undelivered orders, refused refunds and blocked cancellations [34]. Read our Shed (ShedRx) review
- Mochi Health: Washington regulators issued a Notice of Immediate Jeopardy to its compounding partner, Aequita Pharmacy [35]; Eli Lilly is suing Mochi [36]. Read our Mochi Health review
Semaglutide safety facts
The semaglutide label has a boxed warning for thyroid C-cell tumors in rodents; do not use it with a personal or family history of medullary thyroid carcinoma or MEN 2 [19]. Seek care for severe stomach pain that will not go away (possible pancreatitis) or signs of an allergic reaction; low blood sugar is more likely with insulin or a sulfonylurea [19]. The Wegovy label says to stop when pregnancy is recognized [19]. Call 911 in an emergency.
Related: getting semaglutide online, Ozempic vs Wegovy, compounded tirzepatide, research-use-only GLP-1s.
Questions people ask
Is compounded semaglutide safe?
Is compounded semaglutide legal?
In limited cases. Since April 24, 2025, a 503A pharmacy may compound it for an individual patient, and copies of approved semaglutide are barred unless the prescriber documents a significant difference for that patient. 503B facilities may not compound it from bulk [2].
Can you still get compounded semaglutide?
Is compounded semaglutide FDA-approved?
No. Compounded semaglutide is not FDA-approved, FDA does not review it for safety, effectiveness or quality, and FDA says salt forms such as semaglutide sodium and acetate have no lawful basis in compounding [1].
Does compounded semaglutide expire after 28 days?
FDA advises discarding compounded multi-dose GLP-1 vials 28 days after first use, even if medicine is left [1]. Also follow any discard date printed on your pharmacy label.
How much weight can you lose on compounded semaglutide?
Unknown: we found no trials of compounded products. Brand Wegovy 2.4 mg averaged 14.9% weight loss at 68 weeks in STEP 1 [16].
What is the maximum dose of compounded semaglutide?
Sources
37 cited
- FDA's concerns with unapproved GLP-1 drugs used for weight loss. US Food and Drug Administration, Oct 1, 2026.
- FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. US Food and Drug Administration, Apr 1, 2026.
- IVIM Health home page and prices. Ivim, Oct 17, 2026.
- DirectMeds pricing. DirectMeds, Oct 17, 2026.
- Warning letter: Hims & Hers Health, Inc. dba Hims. US Food and Drug Administration, Sep 9, 2025.
- For telehealth companies: what to know when promoting compounded drugs. US Food and Drug Administration, Jun 15, 2026.
- Warning letter: Empower Clinic Services, LLC dba Empower Pharmacy. US Food and Drug Administration, Sep 18, 2026.
- FDA launches green list to protect Americans from illegal imported GLP-1 drug ingredients. US Food and Drug Administration, Sep 5, 2025.
- Warning letter: Hims & Hers Health, Inc. dba Hers. US Food and Drug Administration, Sep 9, 2025.
- FDA intends to take action against non-FDA-approved GLP-1 drugs. US Food and Drug Administration, Feb 6, 2026.
- FDA warns 30 telehealth companies against illegal marketing of compounded GLP-1s. US Food and Drug Administration, Mar 3, 2026.
- FDA warning letters, Hims and Novo Nordisk: compounded GLP-1 update. Frier Levitt, Mar 9, 2026.
- FDA compounded GLP-1 telehealth marketing warning letters. Spakinect, Jun 18, 2026.
- Fifth Circuit upholds FDA GLP-1 shortage decisions. Clark Hill, Sep 10, 2026.
- Two Indian nationals charged in connection with transnational counterfeit Ozempic scheme. US Department of Justice, Sep 29, 2026.
- Once-weekly semaglutide in adults with overweight or obesity (STEP 1). New England Journal of Medicine (PubMed), Feb 10, 2021.
- NAD decision: Willow Health. BBB National Programs, Dec 4, 2025.
- Wegovy self-pay offer. Novo Nordisk (NovoCare), Oct 17, 2026.
- Wegovy (semaglutide) injection and tablets prescribing information. DailyMed, NLM/NIH, Jun 2026.
- Wegovy Medication Guide. DailyMed, NLM/NIH, Jun 2026.
- OrderlyMeds pricing. OrderlyMeds LLC, Oct 17, 2026.
- Eden home page and prices. Eden, Oct 17, 2026.
- bmiMD home page and prices. bmiMD, Oct 17, 2026.
- Found offer terms. Found Health, Inc., Oct 17, 2026.
- FancyMeds home page and prices. FancyMeds, Oct 17, 2026.
- Warning letter: OrderlyMeds LLC dba OrderlyMeds. US Food and Drug Administration, Jun 8, 2026.
- Warning letter: Eden Health International Inc. dba Eden. US Food and Drug Administration, Jun 8, 2026.
- Warning letter: directmeds.com, Inc. dba DirectMeds. US Food and Drug Administration, Sep 9, 2025.
- Warning letter: Fancy Meds, LLC dba Fancy Meds. US Food and Drug Administration, Sep 9, 2025.
- MedVi BBB profile. Better Business Bureau, Oct 17, 2026.
- Warning letter: MEDVi, LLC dba MEDVi. US Food and Drug Administration, Feb 20, 2026.
- TrimRx BBB profile. Better Business Bureau, Oct 17, 2026.
- Thrive Health Group (Fridays) BBB profile. Better Business Bureau, Oct 17, 2026.
- Shed BBB profile. Better Business Bureau, Oct 17, 2026.
- Mochi Health weight loss drugs under scrutiny. NBC Bay Area, Jun 4, 2026.
- Eli Lilly lawsuit against weight loss drug seller gets another shave. Courthouse News Service, Sep 8, 2026.
- Compounding and the FDA: questions and answers. U.S. Food and Drug Administration, 2025-09-16 (accessed 2026-10-17).
This page is general information, not medical advice. Talk with a licensed clinician about your own care.