Compounded GLP-1s, explained

What compounding is

Compounding is an old part of pharmacy practice that predates modern drug manufacturing. The FDA describes it as a practice in which "a licensed pharmacist, a licensed physician or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient."

The classic uses are unglamorous: a liquid version of a tablet for someone who cannot swallow, a preservative-free formulation for a patient with an allergy, a dose that no manufacturer makes. In each case the point is that the approved product does not fit that particular person.

For GLP-1s the process looks like this. The pharmacy buys the active ingredient — semaglutide or tirzepatide — as a raw powder from a supplier, dissolves it to a chosen concentration, fills multi-dose vials under sterile conditions, and ships them against a prescription. The patient draws each dose out of the vial with an insulin syringe, measured in units rather than milligrams.

That last detail is the origin of most of the documented harm in this category, and it is covered in is compounded semaglutide safe? and is compounded tirzepatide safe?.

The FDA's own summary, which telehealth marketing rarely quotes: "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed."

503A pharmacies and 503B outsourcing facilities

Which kind of facility made your medicine determines who inspects it and to what standard. The names come from the sections of the federal Food, Drug, and Cosmetic Act that each operates under, and the difference is not cosmetic.

• Most telehealth providers use a 503A partner; a minority use a 503B facility, and a few use both depending on the product.
• Neither route produces an FDA-approved drug. A 503B facility is inspected more like a manufacturer, but its output is still an unapproved product.
• The practical consequence of the reporting difference: when the FDA counts adverse events for compounded GLP-1s, the agency itself notes the totals are likely to be undercounts, because state-licensed pharmacies are not required to report to it.

Which GLP-1s are compounded, and which cannot be

Two molecules dominate the market. [Compounded semaglutide](/learn/compounded-semaglutide) is the pharmacy-made counterpart of Wegovy and Ozempic; [compounded tirzepatide](/learn/compounded-tirzepatide) is the counterpart of Zepbound and Mounjaro. Liraglutide, the older molecule in Saxenda and Victoza, is compounded much less often.

Beyond the injection, providers sell oral tablets, sublingual drops and "microdose" programmes. These forms exist partly for convenience and partly for legal reasons: an oral version of an injectable drug is easier to argue is not a copy of the approved product.

Additives are common. Vitamin B12 (cyanocobalamin) is the most frequent, marketed as easing nausea; glycine and niacinamide also appear. In April 2026 the FDA stated that adding B12 to a product that otherwise matches an approved strength by the same route does not by itself make it a lawful "different" drug.

Some things cannot lawfully be compounded at all. The FDA has said plainly that retatrutide and cagrilintide — experimental molecules sold widely online as "research peptides" — cannot be used in compounding under federal law. Products labelled "for research purposes only" or "not for human consumption" but sold with dosing instructions are outside the system entirely, and the agency sent warning letters to several such sellers in March 2026.

Ingredient form matters as much as ingredient identity. The FDA has warned that semaglutide salt forms — semaglutide sodium and semaglutide acetate — are "different active ingredients than are used in the approved drugs", and that it is not aware of any lawful basis for their use in compounding.

How the law got to where it is

Compounded GLP-1s became a mass-market product because of a shortage, and the legal question ever since has been what happens when the shortage ends.

Federal law allows a compounder to make what would otherwise be a copy of an approved drug while that drug is on the FDA's shortage list. Both GLP-1s were on it for years. Then the FDA declared the tirzepatide shortage resolved on 2 October 2024, reaffirming it on 19 December 2024, and the semaglutide shortage resolved on 21 February 2025.

Enforcement discretion — the grace period during which the agency said it would not act — ended on 18 February 2025 for 503A pharmacies and 19 March 2025 for 503B facilities on tirzepatide, and on 22 April and 22 May 2025 respectively on semaglutide.

The compounding industry sued. A federal court in Texas sided with the FDA in 2025, and on 27 August 2026 the Fifth Circuit Court of Appeals affirmed, so the shortage removals stand. Separately, on 30 April 2026 the FDA proposed removing semaglutide, tirzepatide and liraglutide from the 503B bulks list altogether, saying it "did not identify a clinical need" for outsourcing facilities to compound them from bulk. No final decision on that proposal had been published as of this article's date.

So why is it still being sold?

Because of a narrow exception that survived all of the above. Section 503A allows a compounded version of an approved drug where a prescriber determines that a change, made for an identified individual patient, will produce a significant difference for that patient. A non-standard dose, a different route, a documented clinical reason — that is the doorway.

The FDA has also said it does not intend to act against a compounder that fills four or fewer prescriptions a month for a given compounded product. Taken together, those two things are the legal architecture behind every "personalized" GLP-1 sold online in 2026.

What makes a version genuinely patient-specific is where the arguments are. The FDA's test for "essentially a copy" looks at the same active ingredient, the same or an easily substitutable strength, and the same route of administration; its April 2026 guidance said that strengths within 10% of an approved product's, by the same route, remain essentially copies even with vitamin B12 added. Law firms tracking the area note the agency has not said how much documentation a prescriber must keep.

State boards of pharmacy add their own rules. Ohio's board, for example, has stated that post-shortage copies are prohibited and that adding B12 alone is not sufficient to make a product lawfully different.

A provider selling a compounded GLP-1 in 2026 should be able to say which pharmacy makes it, why your prescription is patient-specific, and should never describe the product as "the same as" Wegovy or Zepbound. That last claim is precisely what the FDA's warning letters cited.

What the FDA and the manufacturers have actually done

Enforcement has tightened steadily, and it has focused on marketing as much as on manufacturing.

• September 2025 — the FDA sent warning letters to a first group of compounded-GLP-1 sellers, including Hims & Hers, citing claims that implied the products were the same as approved drugs. The same month it launched a broader crackdown on deceptive drug advertising.
• September 2025 — the "Green List" of acceptable GLP-1 active-ingredient suppliers, with Import Alert 66-80 allowing detention of shipments from unlisted sources. The announcement cited dosing errors, unapproved salt forms and hospitalisations.
• 20 February 2026 — warning letters to 30 telehealth companies, for claims implying sameness with approved products and for "obscuring product sourcing by advertising drug products branded with the telehealth firm's name or trademark without qualification". The FDA did not publish the recipients' names.
• Manufacturer litigation — Eli Lilly has sued a series of telehealth compounders over "personalized" claims, with mixed outcomes: cases against Mochi Health and Henry Meds are proceeding, the case against Willow was dismissed with prejudice. Novo Nordisk reported 132 complaints across 40 states and 44 permanent injunctions as of August 2025.
• Where this lands on a profile — every regulatory action we can verify against a provider we track is recorded on its profile, with the source, in the "Is it legit?" section. The directory is the index.

Why it is cheaper, and by how much

Compounded products are cheaper for a structural reason: nobody paid for the trials, the FDA review or the brand. The saving is real, and so is what is being given up.

Across the providers we track, advertised compounded semaglutide runs roughly $60 to $179 a month and compounded tirzepatide roughly $90 to $216 a month — almost always at the lowest dose, often on a prepaid multi-month term, and usually with a separate membership fee of $39 to $149 a month. Ongoing prices after the introductory period cluster higher: about $149–$299 for semaglutide and $279–$349 for tirzepatide.

The comparison has narrowed sharply. The manufacturers now sell direct: Wegovy tablets and Foundayo from $149 a month, Wegovy injections at $199 for a new patient's first two fills then $349, Zepbound vials from $299. At maintenance doses, a compounded product with a membership on top is sometimes no cheaper than the approved drug.

Our price tables are dated and sourced to the page each figure was read on: cheapest GLP-1 without insurance, cheapest compounded tirzepatide, and the per-drug cost without insurance pages.

Six things to check before you buy one

These are the questions our provider profiles answer, and they are the ones worth asking whether or not a provider appears on this site.

• Who is the pharmacy? It should be named, and you should be able to find it with your state board of pharmacy or, for a 503B facility, on the FDA's register of outsourcing facilities.
• Is the ingredient the base form, from a listed supplier? Semaglutide base rather than a sodium or acetate salt, with the raw ingredient from a supplier on the FDA's Green List.
• Who writes the prescription? A clinician licensed in your state, after an actual evaluation. "Instant approval" is a warning sign, not a feature.
• How is the product described? Any claim that it is "the same as" or "equivalent to" an approved drug, or that it is FDA-approved, is the exact language the FDA's warning letters targeted.
• What is the all-in monthly price at the dose you will reach? Medication plus membership, after the introductory period, and what happens when your dose increases.
• How do you cancel, and what happens to a prepaid plan? Several providers require the remaining months of a multi-month plan to be paid out on cancellation.