Compounded Semaglutide and Tirzepatide: Is It Still Legal at Med Spas?

A compounded GLP-1 is semaglutide or tirzepatide made by a pharmacy rather than a finished, FDA-approved product from Novo Nordisk or Eli Lilly.

FDA has a name for a compounded GLP-1 that matches an approved drug: when it uses the same active ingredient in a similar strength and route as an approved drug, the agency treats it as an "essentially a copy" of that drug.

The agency's position on those copies is blunt.

Compounded drugs are not FDA-approved, FDA does not review them for safety, effectiveness or quality before they are marketed, and the agency says they should only be used in patients whose medical needs cannot be met by an FDA-approved drug.

Both molecules spent years on FDA's drug shortage list.

FDA records tirzepatide injection as having been in shortage since 2022, and semaglutide injection products as in shortage since 2022 as well, the latter due to increased demand.

When each shortage ended, FDA set wind-down deadlines: fixed dates after which 503A pharmacies and 503B outsourcing facilities had to stop making essentially-copy products.

Med spas and wellness centers appear in the enforcement record too — the manufacturers' lawsuits discussed below, as reported by trade press and a law-firm alert, name medical spas and wellness centers among the sellers and defendants.

FDA declared the tirzepatide shortage resolved on October 2, 2024, re-evaluated that determination during litigation, and reaffirmed it on December 19, 2024.

The semaglutide injection shortage was declared resolved on February 21, 2025.

Once each shortage ended, FDA set end dates for making essentially copies: first for 503A pharmacies, then for 503B outsourcing facilities.

The dates stood after two preliminary-injunction challenges were denied in federal court.

In the tirzepatide case, the district court denied the plaintiffs' preliminary injunction motion on March 5, 2025, which ended FDA's enforcement grace period for 503A pharmacies; the 503B grace period ran until March 19, 2025.

In the semaglutide case, the 503A deadline had been set for April 22, 2025; when the court denied the preliminary injunction on April 24, 2025, FDA said the 503A enforcement-discretion period had ended, and the 503B period ran until May 22, 2025.

Both suits were brought as Outsourcing Facilities Association v. FDA in the Northern District of Texas.

The current state, per FDA's April 1, 2026 update: neither tirzepatide nor semaglutide appears on the drug shortage list or on the 503B bulks list, so 503B outsourcing facilities generally may not compound them from bulk drug substance.

Only through narrow exceptions.

FDA's April 2026 update restates the main one: under 503A, a compounded GLP-1 with the same active ingredient in a similar strength and route as the approved drug is an essentially copy, unless the prescriber determines and documents that a change produces a significant difference from the commercially available drug for an identified individual patient.

Compounding was not banned outright — what ended in 2025 was shortage-based mass production.

The exception is easy to overstate, and FDA's own example shows how narrow it is: adding another ingredient does not automatically avoid the essentially-copy rule, and semaglutide combined with vitamin B12 at strengths within 10% of approved products may still be considered an essentially copy.

The agency has also said it does not intend to act against a 503A compounder compounding essentially copies “regularly or in inordinate amounts” when it fills four or fewer prescriptions of that compounded product in a calendar month.

For 503B outsourcing facilities the route is narrower still: per FDA's April 1, 2026 update, neither drug appears on the 503B bulks list or the shortage list, so those facilities generally may not compound them from bulk drug substance.

And manufacturers have policed the med spa channel directly: trade press reported in September 2023 that Lilly sued medical spas, wellness centers and compounding pharmacies, including six med spas and wellness centers in Arizona, Florida, Georgia, Minnesota, South Carolina and Utah, alleging compounded tirzepatide was marketed as Mounjaro.

A law-firm alert reports that Novo Nordisk sued nine medical spas, clinics and pharmacies on May 30, 2024 over unauthorized semaglutide products, after earlier 2023 suits.

These cases come from press and law-firm reports rather than court records, we name no individual defendant, and we make no claim about suits after May 2024.

FDA separates compounders into two categories, and each sits differently under the current rules.

A 503A pharmacy compounds for individual prescriptions; the clinical-difference exception and the four-prescriptions-a-month enforcement discretion both belong to that category.

A 503B outsourcing facility is the other category; whether it may compound a given drug from bulk substance turns on FDA's 503B bulks list, which neither semaglutide nor tirzepatide currently appears on.

That split gives you two questions worth asking before you pay for any compounded program:

A program that cannot name its compounder has answered the most important question anyway.

The next section takes up FDA's red-flag list, which includes a pharmacy name you suspect is fraudulent and labels naming pharmacies that do not exist.

FDA's file on unapproved GLP-1 drugs names several product-level red flags, and each is concrete enough to check yourself:

• Salt forms. FDA says semaglutide sodium and semaglutide acetate are different active ingredients from the one used in approved drugs, and that it is not aware of any lawful basis for using them in compounding.
• Research-use-only vials. FDA has warned companies selling semaglutide, tirzepatide, retatrutide, survodutide or mazdutide falsely labeled “for research purposes” or “not for human consumption,” and urges consumers not to buy these products.
• Ingredients that cannot legally be compounded. FDA says retatrutide and cagrilintide cannot be used in compounding under federal law and are not components of any FDA-approved drug.
• A pharmacy you cannot verify. FDA is aware of fraudulent compounded semaglutide and tirzepatide whose labels name pharmacies that do not exist, or licensed pharmacies that did not actually make the product.

FDA's broader red-flag list for telehealth GLP-1 offers adds: claims that a compounded drug is the same as an FDA-approved drug; deep discounts that seem too good to be true; no screening and no prescription by a licensed doctor; no doctor available for questions; and label spelling errors or wrong pharmacy addresses.

Broader warning signs about a clinic itself are covered in med spa red flags.

The agency has also established a “green list” import alert (66-80) to help stop GLP-1 active ingredients with potential quality concerns from entering the US supply chain.

The approved products have published cash prices, which makes comparison possible.

Zepbound (tirzepatide, Eli Lilly) is FDA-approved, with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight plus at least one weight-related condition, and to treat moderate to severe obstructive sleep apnea in adults with obesity.

Wegovy (semaglutide, Novo Nordisk) is FDA-approved for weight reduction and maintenance in adults and children 12 and older with obesity, among other indications.

For what each drug is approved for, its results and its monthly cost from the maker, see our semaglutide guide and tirzepatide guide.

Lilly's self-pay prices, as published and read on October 16, 2026, were $299 for a one-month (28-day) supply of Zepbound at 2.5 mg (single-patient-use KwikPen or four vials), $399 for 5 mg, $499 for 7.5 mg and $699 for 10, 12.5 and 15 mg, with a $449 offer for 7.5–15 mg if each refill is bought within 45 days of the previous one.

Novo Nordisk's self-pay price for Wegovy injection was $349 per month for 0.25–2.4 mg and $399 for Wegovy HD 7.2 mg, with new patients paying $199 per month for the first two fills of 0.25 mg and 0.5 mg through December 31, 2026.

Manufacturers can change these offers at any time.

There is no equivalent published number on the compounded side.

We could not confirm a national price for compounded semaglutide or tirzepatide, and a clinic's program price is its own; if a monthly total sits far below the makers' cash prices, that is one of FDA's red flags.

Wegovy and Zepbound are prescription-only drugs: they need a valid prescription from a licensed prescriber, and FDA tells patients to fill prescriptions at state-licensed pharmacies.

A program built on a compounded product should be able to meet the same standard — a named pharmacy, a real prescriber and paperwork where the rules require it.

The steps below are how to check.

FDA's own framing is the honest summary: compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.

If you are still deciding whether a med spa program makes sense at all, start with our medical weight loss guide.