A licensed clinic, a licensed doctor and a licensed pharmacy can all stand behind a compounded, or pharmacy-mixed, weight medicine priced far below the brand-name product, and it is still not that product with a cheaper label on it. A brand-name weight medicine is an approved drug, and consumers and health care professionals rely on FDA's drug approval process to verify its safety, effectiveness and quality. Compounded drugs are not FDA approved, which means the agency does not review their safety, effectiveness or quality before they are marketed.
Who is allowed to compound a medicine
Compounding is, generally, a licensed pharmacist or a licensed physician combining, mixing or altering the ingredients of a drug to make a medication tailored to one patient's needs. At an outsourcing facility, a kind of compounder that registers with FDA, a person working under the supervision of a licensed pharmacist does it. Compounding commonly happens in pharmacies, and whoever makes a compounded product is its compounder.
Among the weight medicines compounded this way are GLP-1 drugs, a group that includes semaglutide and tirzepatide. Semaglutide is the active ingredient in Wegovy, a brand-name weight medicine that comes as an injection and as a tablet, and tirzepatide is the active ingredient in Zepbound.
A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as someone allergic to a dye who needs the medicine made without it, or an older person or a child who cannot swallow a tablet or capsule and needs a liquid. A compounded drug might be appropriate for one of two reasons: a patient's medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available.
A lower price is not one of those two reasons. Ask the doctor prescribing it what need of yours the compounded version meets that an approved product cannot, and whether the approved product is available to you.
Nor is a compounded drug a generic. A generic drug is approved by FDA under its own section of federal law, which includes showing therapeutic equivalence to a brand-name drug, and a compounded drug is not approved by FDA.
What can go wrong in a drug FDA has not reviewed
A drug FDA has not reviewed can go wrong in how it is made: poor compounding practices can result in serious drug quality problems, such as contamination or a drug that holds too much or too little active ingredient, and those problems can lead to serious injury and death.
The active ingredient itself can differ from the one in the brand-name product. Some of the semaglutide that compounders sell may be a salt form, including semaglutide sodium and semaglutide acetate, and those are different active ingredients from the one used in the approved drugs. FDA is not aware of any lawful basis for their use in compounding. Read the ingredient name on the vial's label against the one on your prescription, and if the label adds a salt, such as sodium or acetate, after the word semaglutide, ask the pharmacy that filled it why, and tell the prescriber, before you inject from that vial (see Check a vial or pen that doesn't match your prescription).
Dosing mistakes may also have caused harm. Some reports of adverse events, a number of them needing hospital care, may be related to dosing errors with injectable compounded semaglutide, in which patients measured and gave themselves the wrong amount, and in some cases health care professionals miscalculated it. Before your first injection, talk with the prescriber or the compounder about how to measure and administer the intended dose.
Injectable GLP-1 drugs are meant to be kept refrigerated, as their package inserts state, and there have been complaints of compounded ones delivered warm or packed with too little ice. Do not use an injectable GLP-1 drug that reaches you warm or short of refrigeration, whoever made it, since arriving that way can affect the drug's quality; contact the pharmacy that sent it before you do anything else with it.
After an injection of either version, slurred speech, trouble breathing or swallowing, or swelling in the face, eyes or tongue can be signs of anaphylaxis, a life-threatening allergic reaction that medicine allergies commonly cause; phone 911 immediately, or your local emergency number, or head straight to the nearest emergency room (see Hives with trouble breathing after an injection mean 911).
How a compounding pharmacy is inspected
How a compounding pharmacy is inspected depends on how it is registered, as a state-licensed pharmacy under section 503A of federal law or as an outsourcing facility under section 503B:
| What applies | State-licensed pharmacy, section 503A | Outsourcing facility, section 503B |
|---|---|---|
| Day-to-day oversight | The state board of pharmacy, generally | FDA, mainly |
| FDA inspections | Surveillance and for-cause | On a risk-based schedule |
| Federal manufacturing-quality rules, called current good manufacturing practice | Do not apply | Apply |
| FDA review of the drug before it is sold | None | None |
A state-licensed pharmacy that is not an outsourcing facility has no federal duty to report adverse events to FDA, so adverse events from compounded semaglutide and tirzepatide are likely underreported.
Ask the clinic for the name of the pharmacy that will make yours, and whether it is a 503A pharmacy or a 503B outsourcing facility. People who buy compounded drugs online or through a telehealth platform may not know the identity of the compounder, or whether it is appropriately licensed and regulated. Deep discounts, prices that look too good to be true and a company claiming its compounded drug matches an approved one are all among the warning signs to look for in a telehealth company, so a large price gap is a reason to ask these questions before you pay.
For a 503A pharmacy that ships to you, look its name up in your state board of pharmacy's license database, and if it is not listed there, do not use it. For a 503B facility, check the registered outsourcing facilities table, updated weekly. Each entry shows the facility's last FDA inspection, and a facility whose entry reads "Not yet inspected" is waiting for a risk-based FDA inspection whose timing can vary. For any state enforcement action against a facility, check with the board of pharmacy in the state where it is located.
When you buy a medicine online, buy only from state-licensed pharmacies. A seller who cannot name a licensed pharmacy at all leaves you nothing to look up, and buying from one carries risks of its own (see Is a cheap injection from a private seller safe to buy?).
Pregnancy, breastfeeding and the pill in the brand-name labels
Pregnancy, breastfeeding and the pill are covered in the brand-name labels, the prescribing information Wegovy and Zepbound were approved with, and the label on a compounded version never went through that approval.
According to the Wegovy label, animal studies point to possible risks to a fetus, and weight loss offers no benefit to a pregnant patient and may cause fetal harm, so once a pregnancy is recognized, the patient is to be told of the risk, and Wegovy is to be stopped if it is being used for weight reduction. Whether Wegovy raises the risk of major birth defects, miscarriage or other harm to mother or fetus has not been established, because the data from pregnant patients are insufficient. Wegovy is also to be stopped at least two months before a planned pregnancy, because semaglutide stays in the body a long time, so tell whoever prescribes for you as soon as a pregnancy is in your plans.
Under the Wegovy label, patients on Wegovy tablets are to be advised not to breastfeed during that treatment. For the injection, no data exist on injected semaglutide in human milk, on its effects on a breastfed infant, or on its effects on milk production, and the benefits of breastfeeding are to be weighed against how much the mother needs the medicine and against any possible harm to the infant, from the medicine or from her own condition. That weighing is for you and the prescriber to do together.
According to the Wegovy label, semaglutide delays stomach emptying, which could change how well medicines taken by mouth are absorbed, a birth control pill among them. In studies with semaglutide tablets, ethinyl estradiol and levonorgestrel, hormones used in many birth control pills, showed no clinically significant difference in how the body handled them, and the effects of oral medicines taken alongside Wegovy are still to be monitored, so name your pill when you talk to the prescriber.
According to the Zepbound label, pregnant patients are to be advised that weight loss is not recommended during pregnancy and to stop tirzepatide once a pregnancy is recognized, and the data from pregnant patients are insufficient to evaluate its risk of major birth defects, miscarriage or other harm. Under the Zepbound label, tirzepatide may make birth control pills less effective, so patients taking them are to be advised to switch to a method not taken by mouth, or to add a barrier method, for four weeks from the start of treatment and for four weeks after every step up in dose (see Can a weekly weight injection make the pill less reliable?). According to the Zepbound label, a single-dose study found the concentration in breast milk undetectable or low compared with the dose the mother took, and no data are available on how it affects a breastfed infant or milk production.
Each label was written for its own product, so before you start a compounded version, ask the prescriber which of these positions they want you to follow. If you find out you are pregnant while taking either version, tell the prescriber that day.
Through NicoCares, the medicine a physician may prescribe is compounded semaglutide or tirzepatide, prepared by a state-licensed pharmacy, so the license and label checks above apply to it as well, and so does the question of need: ask your care team what need of yours the compounded version meets that Wegovy or Zepbound cannot, and which pharmacy makes it, in Spruce, the messaging app where they answer you. For you, telling the prescriber about a pregnancy that day starts with writing to your care team there, and since no turnaround is stated for their answers, phone your own doctor's office that day as well.
