What compounding means
A compounded drug is made by a pharmacy for a specific patient or purpose, outside the FDA approval process. Compounding has legitimate uses, such as making a version without an ingredient someone is allergic to.
Compounded drugs are not reviewed by the FDA for safety, effectiveness or quality before they're sold.
Why compounded GLP-1s spread, then shrank
When a drug is on the FDA shortage list, federal law gives pharmacies more room to make copies. Semaglutide and tirzepatide were in shortage from 2022, and compounded versions became widespread.
| Ingredient | FDA said the shortage was resolved | Grace periods for pharmacies |
|---|---|---|
| Tirzepatide | Late 2024 (reaffirmed December 2024) | Ended in early 2025 |
| Semaglutide | February 2025 | Ended in spring 2025 |
After those dates, making copies that are essentially the same as the approved drugs became much more limited. Rules and enforcement keep shifting, so check the FDA compounding page for what is in effect as of your reading.
What the FDA has warned about
- Dosing errors. Compounded versions often come in multi-dose vials, and people have measured the wrong number of units. See the titration glossary entry for why dose steps matter.
- Different salt forms. Some products used semaglutide sodium or acetate, which are not the form in approved drugs.
- Unknown quality. Products from unregistered or overseas sources may contain the wrong amount of drug or none at all.
Approved and compounded at a glance
| FDA-approved drug | Compounded version | |
|---|---|---|
| FDA review of safety and effectiveness | Yes, before approval | No |
| Manufacturing checks | FDA-inspected facilities, approved process | Varies; 503B outsourcing facilities have more oversight than 503A pharmacies |
| Form | Prefilled pen, approved vial or tablet | Often a multi-dose vial measured with a syringe |
| Dose units | Milligrams on a fixed device | Often units on a syringe, which must be converted |
| Label and Medication Guide | Yes | No FDA-approved label |
| Savings cards | Available for some patients | Not applicable |
Units and milligrams are not the same thing. A dose in units depends on how concentrated the vial is, which is why confusion between them has led to overdoses.
Questions to ask before using one
- Is there a clinical reason I can't use the FDA-approved version?
- Is the pharmacy state-licensed, and is it a 503A or registered 503B facility?
- Exactly which ingredient and salt form is in the vial?
- Who shows me how to measure the dose, and in what units?
- What do I do if I think I took too much?
Sunny Weigh does not list, rank or link to compounding sellers. See our editorial policy.
Cheaper approved options may exist
Drug makers now sell some approved GLP-1s directly at cash prices, and savings cards can cut costs for people with commercial insurance. Compare them in the cost index or with the cost calculator. Details for each ingredient: compounded semaglutide and compounded tirzepatide.
When to call your doctor
- Severe nausea or vomiting after a dose, which can signal an overdose
- Dizziness, fainting or signs of low blood sugar
- You're not sure how many units your dose should be
For a suspected overdose, call Poison Control at 1-800-222-1222.
Run the numbers
Read next
Common questions
Is compounded semaglutide legal?
Compounding is legal in limited circumstances. Since the FDA declared the semaglutide shortage over in February 2025, making copies essentially the same as Wegovy or Ozempic is much more restricted.
Is compounded tirzepatide the same as Zepbound?
No. Compounded versions are not FDA-approved and haven't been reviewed for safety, effectiveness or quality.
What is the biggest risk with compounded GLP-1s?
The FDA has highlighted dosing errors with multi-dose vials, along with products of unknown quality or the wrong salt form.
Sources
Clinician review pending. Drafted from primary sources and waiting for sign-off by a licensed clinician (MD, DO or PharmD) before launch. Every number is checked against its source. Drug facts are re-checked quarterly, prices monthly and whenever a label changes. How we review · Report an error