Compounded semaglutide and tirzepatide. What you need to know.
Compounded GLP-1 products are not FDA approved and are not generic versions of the brand medicines. Some may meet an individual patient need under the law, but the vial, concentration, syringe, storage, and beyond use date must all be checked. This guide shows you how to stay safe.
This guide is here to teach you. It is not medical advice, and it does not replace your doctor or pharmacist. Always do what your doctor tells you, and ask a pharmacist before you change how you take any medicine.
Print this guide for your fridgeRead this before using any compounded GLP-1 product
- Compounded semaglutide and tirzepatide are not FDA approved drugs and are not FDA approved generic versions of Ozempic, Wegovy, Mounjaro, or Zepbound. They do not undergo FDA premarket review for safety, effectiveness, quality, manufacturing, or labeling.
- Units measure syringe volume, not milligrams of medicine. Never copy a unit dose from another vial or concentration. FDA has received reports of overdoses, some requiring hospitalization, related to measurement and calculation errors with compounded injectable semaglutide.
- Do not use a product that cannot be verified. Contact the pharmacy printed on the label to confirm it made or dispensed the product. If you think you injected too much, call Poison Control at 1-800-222-1222 and your clinician promptly, and call 911 for severe symptoms.
Your 60 second compounded GLP-1 safety checklist
- It is not a generic.Compounded products are not FDA approved and are not FDA approved generics of the brand medicines.
- Units are volume, not medicine.On a U-100 syringe, 100 units equals 1 mL of volume. That does not mean 100 units of semaglutide or tirzepatide.
- Never copy units from an old vial.When the vial concentration changes, the same milligram dose needs a different syringe mark. Have the pharmacist write the exact mark to use.
- Verify the source.Use a valid prescription filled by a state licensed pharmacy. Contact the pharmacy on the label to confirm it dispensed the product.
- Follow the label for storage.There is no universal storage rule. Follow the dispensing label exactly, and do not use past the beyond use date.
- Use a new sterile syringe every time.Never share. Put used needles and syringes directly into an FDA cleared sharps container.
FDA approved versus compounded. What is the difference?
FDA approved products go through premarket review for safety, effectiveness, quality, manufacturing, and labeling. Compounded drugs do not. Compounding is not the same as generic manufacturing.
Current federal rules generally restrict routine compounding of products that are essentially copies of commercially available approved drugs. A compounded product may sometimes be legally appropriate for an identified patient whose medical need cannot be met by an available approved product, but the prescriber and dispensing pharmacy must determine that under current law.
- Vial versus pen. Approved GLP-1 pens have product specific Instructions for Use. Compounded medicine often comes in a multi dose vial with a separate syringe. That means extra steps: identify the concentration, choose the correct syringe, clean the stopper, draw the exact volume, remove air bubbles without losing the dose, inject under the skin, and track the beyond use date. A patient trained on a pen still needs separate vial and syringe training.
- Salt forms. FDA approved semaglutide products contain semaglutide base. Semaglutide sodium and semaglutide acetate are different salt forms. FDA has stated it does not have information showing these salts have the same chemical and pharmacologic properties as the active ingredient in approved products, and it is not aware of a lawful basis for their use in compounding. Ask the dispensing pharmacy to identify the exact active ingredient. The word semaglutide on an advertisement is not enough.
The simple version: a compounded GLP-1 is a custom made preparation, not a reviewed and approved drug. It can only be used safely when the source, ingredient, concentration, syringe, and directions have all been verified by a pharmacist.
Milligrams, milliliters, and units. Why the words matter.
Milligrams, written mg, describe the amount of active drug. Milliliters, written mL, describe liquid volume. Syringe units describe marked volume on a particular syringe.
On a U-100 insulin syringe, 100 units equals 1 mL. That does not mean 100 units of semaglutide or tirzepatide. Units are a measure of volume, not a measure of medicine.
Here is why that matters. The number of syringe units needed for a prescribed milligram dose changes when the vial concentration changes. The same milligram dose may need a different volume with a new vial. Do not calculate the conversion yourself. Fairview or the dispensing compounder must inspect the label, the concentration, and the syringe together, and write down the exact mark to use.
Common dosing mistakes, and how to avoid them
FDA has received reports of overdoses, some requiring hospitalization, related to measurement and calculation errors with compounded injectable semaglutide. The most common mistakes are simple ones.
Drawing to the wrong syringe line, or confusing 5 units with 50 units. Copying units from a previous vial that had a different concentration. Confusing mg per mL with the total mg in the vial. Using a larger syringe that makes a small volume hard to measure. Increasing the dose faster than prescribed, or dosing more often than weekly. Repeating a dose after vomiting. Using a kitchen or oral syringe for an injection. Following a telehealth portal instruction that does not match the dispensed label.
Before your first dose, the pharmacist should place the actual syringe beside the actual vial and point to the prescribed line. Use a new sterile syringe and needle each time. Never share. Clean the vial stopper as directed and let it dry. Confirm the medicine is the expected color and free of unexpected particles. Inject only by the route and site on the label. Place used needles and syringes directly into an FDA cleared sharps container.
Storage, beyond use dates, and when to call
There is no universal storage rule for compounded GLP-1 products. Refrigeration, light protection, room temperature limits, and the beyond use date depend on the formulation, the container, sterility information, and the pharmacy data. Follow the dispensing label exactly.
The beyond use date is not a manufacturer expiration date. It is the date after which that compounded preparation should not be used. Write the first puncture date on a multi dose vial if instructed. Do not freeze, heat, shake, or use the product past the labeled beyond use date unless the dispensing pharmacy gives product specific written directions.
If you miss a dose:
- Do not repeat a dose after vomiting.
- Do not increase the dose faster than prescribed or dose more often than weekly.
- If the vial arrived warm, do not guess. Keep it as directed and call the dispensing pharmacy with the time and temperature details before using it.
- Do not use old directions with a new vial until the concentration and syringe have been checked.
- If you are not sure what to do, call Fairview at 601-544-4871.
Warning signs. When to call and when to get help.
Check the product before every use:
- A label, concentration, syringe, or direction that differs from the last fill.
- Unexpected particles, cloudiness, color change, leakage, broken seals, or temperature exposure.
- Missing pharmacy information, spelling errors, an address that does not match the pharmacy, loose supplies, damaged seals, or a product sold as research use only.
Call your pharmacist or doctor promptly if you notice:
- Repeated vomiting or diarrhea, dizziness, reduced urination, or inability to keep fluids down.
- Severe constipation, abdominal swelling, or gallbladder symptoms.
- A possible dosing error of any kind.
Get urgent help or call 911 if you have:
- Trouble breathing, face or throat swelling, fainting, loss of consciousness, or a seizure.
- Severe low blood sugar when the person cannot swallow.
- A suspected large overdose. Also call Poison Control at 1-800-222-1222 and keep the vial, syringe, and label available.
- Severe, steady abdominal pain, severe dehydration, or uncontrolled vomiting.
Product source and counterfeit warning signs
Use a valid prescription filled by a state licensed pharmacy. The label should identify the patient, the prescriber, the dispensing pharmacy, the active ingredient, the concentration, the directions, lot or control information, storage, and the beyond use date as required.
Be cautious about missing pharmacy information, spelling errors, an address that does not match the pharmacy, loose supplies, damaged seals, particles, discoloration, or a product sold as research use only.
Contact the pharmacy printed on the label to confirm it made or dispensed the product. Do not use a product that cannot be verified.
No legitimate patient specific compounded prescription drug should be sold to you without an appropriate prescription.
Be careful with added ingredients too. Added vitamins are not automatically helpful. They change the formulation and may add risks or uncertainty. Ask why each ingredient is present and whether it was prescribed for an individual need.
What it costs
The cost is different for every person, because every insurance plan is different.
Here is the honest way to find your price. If you pay cash, call Fairview and we will give you a price for your situation. If you have private insurance, there may be a coupon or a savings program from the maker of the drug that helps lower your cost, and we will check if one is available for you. The best step is to let a pharmacist look at your plan. We do this for every patient.
Do not let cost make you skip doses. Call us first. There is almost always something we can do.
Availability and insurance coverage can change. Fairview will check whether an FDA approved lower cost alternative, a manufacturer savings program, an insurance exception, or another cost saving option is available for your specific prescription.
What should be checked
With a compounded product, the checking falls on you and your pharmacist. Here is what a careful review looks like.
Your prescriber should confirm:
- That a patient specific medical need exists that an available FDA approved product cannot meet.
- That current federal and state requirements are satisfied. Availability, shortage status, and legal conditions change, so this must be checked at the time of dispensing.
- Your dose in clear milligrams, not just syringe units.
Your pharmacist should inspect, with the product in hand:
- The source, active ingredient, concentration, and total volume.
- The prescribed milligrams and the matching milliliters and syringe mark.
- The storage directions and beyond use date.
- Whether the written directions match the dispensed label.
Bring the vial, the carton or bag, the dispensing label, your syringes, the written directions, and any portal message. A photograph may miss fine print or the syringe scale. The physical product is best.
Special situations
A new vial arrives.
Do not use your old directions until the concentration and syringe have been checked. The same milligram dose may require a different volume. Have the pharmacist confirm the exact mark before the first injection from any new vial.
The vial arrived warm or looks wrong.
Do not guess. Keep it as directed and call the dispensing pharmacy with the time and temperature details before using it. Do not use a product with unexpected particles, cloudiness, discoloration, leakage, or broken seals.
Your dose is written only in units.
The syringe is marked in volume units. Your dose should also be clear in milligrams and milliliters so the pharmacist can verify the conversion. Ask for it in writing.
You think you injected too much.
Call Poison Control at 1-800-222-1222 and your clinician promptly. Call 911 for severe symptoms. Keep the vial, syringe, and label available.
How Fairview helps with compounded GLP-1 questions
Products that sound similar may have different ingredients, strengths, directions, and storage. That is why we ask you to bring the actual product in.
When you bring the product in:
- We inspect the vial, label, concentration, and syringe together.
- We confirm the prescribed milligrams and write the exact syringe mark to use.
- We check the storage directions and beyond use date.
- We help verify the dispensing pharmacy on the label.
For syringe education:
- We place the actual syringe beside the actual vial and point to the prescribed line.
- We review sterile technique, injection site, and sharps disposal.
Any time something changes:
- Contact us before switching, converting a dose, or using a product you do not recognize.
- Ask Dr. Mike a question through our website, or call 601-544-4871.
Questions patients ask about compounded GLP-1 products
No. It is not FDA approved and is not an FDA approved generic.
Related guides
Have a question about a compounded GLP-1 product?
Fairview can review the actual prescription, package, device, dose, insurance requirements, and other medicines with you. Personalized counseling matters because products that sound similar may have different approved uses, strengths, timing rules, and storage. Contact us before switching, converting a dose, or using a product you do not recognize.