Compounded semaglutide is semaglutide prepared by a compounding pharmacy for an identified patient under a prescription. It is not a generic Ozempic or Wegovy, and the exact preparation has not gone through the review attached to those brand products. Through Promise, semaglutide is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here — semaglutide with vitamin B12 — is not FDA-approved.
That distinction matters more in 2026. The national shortage of semaglutide injection has been resolved, FDA has warned specifically about semaglutide salt forms, and dosing errors have exposed how much can be lost when a label moves unclearly between milligrams, milliliters, and syringe units.
What compounded semaglutide actually is
Compounding is the preparation of a medication for a particular prescription. Under section 503A of the Federal Food, Drug, and Cosmetic Act, it is done by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician. FDA's 503A and 503B comparison says a 503A prescription must identify an individual patient.
A compounded drug is not a generic. A generic has its own FDA approval and must establish requirements including therapeutic equivalence. A compounded preparation is made under a different framework and does not receive premarket review for safety, effectiveness, or quality. How compounded medications are made explains the pharmacy process in more detail.
| Question | Ozempic or Wegovy | Compounded prescription |
|---|---|---|
| Who supplies it? | A drug manufacturer | A compounding pharmacy |
| What is reviewed? | The marketed product and its label | The exact preparation is not reviewed before marketing |
| How is it supplied? | Standardized branded presentations | The container and concentration can vary by pharmacy |
| Is it a generic? | No; these are brand products | No; compounding is a separate category |
| Who is it for? | People who fit the product's labeled uses | An identified patient with a prescription |
Promise's semaglutide product contains vitamin B12. FDA's April 2026 update says adding another active ingredient such as B12 does not by itself settle whether a preparation is essentially a copy of a commercially available product. Route, strength, and a documented patient-specific difference still matter. FDA also says the safety and effectiveness of combining semaglutide with added ingredients have not been established.
Ozempic and Wegovy are evidence, not equivalents
Ozempic and Wegovy are brand names with different labels. The current Ozempic prescribing information covers adults with type 2 diabetes, including specified cardiovascular and chronic-kidney-disease outcomes. The current Wegovy prescribing information includes weight management, cardiovascular-risk reduction in a defined population, and MASH treatment for its injection, with separate indications for its tablets.
The clinical evidence belongs to the formulation and protocol that were studied. In STEP 1, published in the New England Journal of Medicine in 2021, 1,961 adults with overweight or obesity and without diabetes received semaglutide 2.4 mg or placebo alongside lifestyle intervention for 68 weeks. Mean body-weight change was −14.9% with semaglutide and −2.4% with placebo (Wilding et al., STEP 1). In SELECT, published in the same journal in 2023, a major cardiovascular event occurred in 6.5% of the semaglutide group and 8.0% of the placebo group among 17,604 adults with established cardiovascular disease and overweight or obesity but no diabetes (Lincoff et al., SELECT).
Those results describe the trial products, populations, and dosing protocols. They do not establish that every compounded preparation is equivalent.
The semaglutide salt form matters
The active ingredient in the approved products is semaglutide base. FDA says semaglutide sodium and semaglutide acetate are different active ingredients. The agency says it lacks information showing that the salts have the same chemical and pharmacologic properties as the active ingredient in the approved drugs and is not aware of a lawful basis for using those salts in compounding. That language appears in FDA's current GLP-1 concerns.
This is not a technicality a consumer should have to infer from a glossy product name. A prescription, dispensing label, and pharmacy record should identify what was prepared. The word "semaglutide" alone does not answer whether a seller used the base form or a salt.
Why milligrams, milliliters, and units get confused
Milligrams describe the amount of drug. Milliliters describe liquid volume. "Units" are markings on a syringe, so their drug amount depends on the concentration in the vial. They are not interchangeable names for one dose.
FDA received reports of people administering five to 20 times the intended amount after confusion involving multiple-dose vials, varying concentrations, syringe sizes, and conversions. Some needed medical care or hospitalization. The agency's dosing-error alert also describes clinician calculation errors. A 2023 poison-center case series reported three compounded-semaglutide administration errors; two involved tenfold doses, with nausea, vomiting, and abdominal pain (Lambson et al., Journal of the American Pharmacists Association).
The actual dose is set by the prescriber. The prescription, concentration, volume, syringe markings, and pharmacy directions need to agree without requiring the patient to perform a fresh conversion. For context on how published label schedules are structured, see the semaglutide dosage guide.
Where compounding rules stand in August 2026
FDA determined on February 21, 2025 that the national shortage of semaglutide injection was resolved. The shortage-based enforcement-discretion period for 503A pharmacies ended after a federal court decision on April 24, 2025; the 503B period ended May 22, 2025. FDA's April 1, 2026 compounding update also lists semaglutide on neither the 503B bulks list nor the drug-shortage list and reminds compounders that section 503A generally restricts regular or inordinate production of products that are essentially copies.
The shortage ending did not erase patient-specific compounding. FDA's framework recognizes a documented prescriber determination that a change produces a significant difference for an identified patient. It also says a pharmacy must satisfy the other applicable conditions; a marketing claim about customization is not enough. A licensed provider may still prescribe a compounded formulation when the legal and clinical conditions are met — that decision is between the patient and the doctor.
What a legitimate prescription route makes clear
The meaningful comparison is not simply brand versus vial. It is an accountable prescription path versus an unknown product sold online without clinical screening. A legitimate route identifies the prescriber, the licensed dispensing pharmacy, the ingredient, the concentration, and the instructions tied to that exact container. Grey-market vials sold without a prescription provide none of that chain.
At Promise, a licensed provider reviews every request and not everyone qualifies. The review considers medical history, current medications, and class-specific issues such as a personal or family history of medullary thyroid carcinoma or MEN 2, pregnancy, prior pancreas or gallbladder problems, kidney risk during dehydration, and medicines that can increase hypoglycemia risk. If prescribed, the partner pharmacy dispenses the preparation and follow-up stays connected to the clinical relationship.
FDA reported 990 adverse-event reports associated with compounded semaglutide as of May 31, 2026. The agency also cautions that a report does not establish that the product caused the event, while reporting from many state-licensed pharmacies is not mandatory. That is useful context, not a verdict on an individual prescription. Nausea, vomiting, diarrhea, abdominal pain, and constipation also appear in semaglutide labeling; the semaglutide side-effects overview separates common effects from reasons to contact a clinician promptly.