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Not FDA-approved

Compounded GLP-1s: what they are, what changed and how to choose

Lower-cost semaglutide and tirzepatide prepared by licensed pharmacies for individual prescriptions. Not FDA-approved.

Small unlabeled glass vial on a warm limestone surface

By the RxLineup editorial team · Fact-checked against provider sites and FDA labels · Updated

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Active ingredient
Semaglutide or tirzepatide
Made by
State-licensed compounding pharmacies
Form
Injection (vial) or tablet
Self-pay price
Not published by the programs we track.

What a compounded GLP-1 is

A compounded GLP-1 is semaglutide or tirzepatide prepared by a state-licensed compounding pharmacy for an individual patient’s prescription. It is not Wegovy or Zepbound, and not a generic of either. A compounding pharmacy prepares it, and compounded drugs are not FDA-approved: the FDA does not review them for safety, effectiveness or quality before they are sold.

What changed in 2025 and 2026

During the GLP-1 shortages, the FDA allowed pharmacies to make copies of the brand drugs. That ended once the shortages were declared over.

DateWhat happened
Dec 19, 2024FDA confirms the tirzepatide shortage is resolved.
Feb 21, 2025FDA declares the semaglutide shortage resolved.
Apr–May 2025Grace periods for pharmacies end; courts decline to block the FDA.
Sep 2025FDA sends more than 50 warning letters, largely over claims that compounded drugs are the same as approved ones.
Mar 3, 2026FDA warns 30 more telehealth companies; over 70 warned in six months.
Apr 30, 2026FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B bulk list.

Today, a 503A pharmacy can still compound for an individual patient with a prescription, but it may not regularly make what are essentially copies of a commercially available drug. A prescriber can document a significant clinical difference for a specific patient, such as a dose the brand does not offer.

How to choose a compounded program carefully

  • Ask which pharmacy fills your prescription, and check that it is state-licensed. Some programs name the pharmacy before you pay.
  • Be wary of “same as Wegovy” claims. The FDA has warned companies for saying compounded drugs are generic or equivalent to approved drugs.
  • Look for a real clinical review and a clinician who adjusts your dose over time.
  • Check LegitScript certification and read the refund terms before you prepay.

For what it costs, read How much does compounded tirzepatide cost per month?. For the steps, read How to get the Wegovy pill online.

Common side effects

Stomach-related side effects are the most common, especially while the dose is going up. Compounded versions have no trials of their own; these are the brand labels’ rates, people on the medication vs placebo.

Scroll sideways to see the full table

Side effect Wegovy 2.4 mg Zepbound 5–15 mg Foundayo
Nausea 44% vs 16% 25–29% vs 8% 26–35% vs 10%
Diarrhea 30% vs 16% 19–23% vs 8% 21–25% vs 11%
Vomiting 24% vs 6% 8–13% vs 2% 13–24% vs 4%
Constipation 24% vs 11% 11–17% vs 5% 20–27% vs 9%
Abdominal pain 20% vs 10% 9–10% vs 5% 13–14% vs 7%
Fatigue 11% vs 5% 5–7% vs 3% 6–9% vs 4%
Hair loss 3% vs 1% 4–5% vs 1% 4–5% vs 2%

Source: Wegovy (rev. 06/2026), Zepbound (rev. 08/2026) and Foundayo (rev. 07/2026) prescribing information.

Safety: GLP-1 medications carry a boxed warning for thyroid C-cell tumors and are not for people with a personal or family history of medullary thyroid carcinoma or MEN 2. Labels also warn about pancreatitis, gallbladder problems, low blood sugar with some diabetes drugs, kidney problems from dehydration and severe stomach problems. Talk to a licensed clinician about your history.

Legal status: Prescription only; compounded and not FDA-approved.

Questions, answered

How much do compounded GLP-1s cost without insurance?

None of the programs we track publishes a compounded price. Some charge more as your dose rises.

Are compounded GLP-1s FDA-approved?

No. Compounded GLP-1s are not FDA-approved, and the FDA does not review them for safety, effectiveness or quality.

How do you take compounded GLP-1s?

Usually as a weekly injection from a vial; some programs also offer tablets. Your prescriber sets the dose for you individually.

How much weight do people lose on compounded GLP-1s?

Compounded versions were not part of the clinical trials behind the brand-name drugs. Individual results vary.

Can I get compounded GLP-1s online?

Yes, from licensed online programs that work with state-licensed compounding pharmacies. A licensed clinician must decide they are right for you.

Sources

  1. FDA: policies for compounders as national GLP-1 supply stabilizes (updated Apr 1, 2026)
  2. FDA: what telehealth companies should know when promoting compounded drugs (Jun 15, 2026)
  3. FDA warns 30 telehealth companies over compounded GLP-1 marketing (Mar 3, 2026)