Compounded vs branded GLP-1s

What is compounded semaglutide or tirzepatide?

Compounded semaglutide or tirzepatide is a version made by a pharmacy or outsourcing facility rather than by Novo Nordisk or Eli Lilly. Compounded drugs are not FDA approved, so FDA doesn't review them for safety, effectiveness or quality before they're marketed². FDA says they should only be used when a patient's needs can't be met by an FDA-approved drug².

US law has two routes for compounding¹:

• 503A: a state-licensed pharmacy or physician compounds for an individual patient, based on a prescription.
• 503B: an outsourcing facility compounds in larger amounts. It can only use a bulk ingredient if that ingredient is on FDA's 503B bulks list or the drug is on FDA's shortage list.

Is the semaglutide and tirzepatide shortage over?

Yes. FDA decided the tirzepatide injection shortage was resolved on December 19, 2024, and the semaglutide injection shortage on February 21, 2025¹. Both had been in shortage since 2022 because of demand¹.

That matters because a drug on FDA's shortage list can be copied more freely by compounders. When a shortage ends, FDA generally treats the drug as commercially available again¹. FDA gave compounders grace periods, which have now ended¹.

We couldn't confirm a final FDA decision on the April 2026 proposal when this page was checked. FDA said it would consider comments before deciding⁴.

Can pharmacies still compound semaglutide and tirzepatide?

Only within narrow limits. FDA says outsourcing facilities (503B) can't compound these drugs from bulk ingredients, because neither is on the bulks list or the shortage list¹. State-licensed pharmacies (503A) can't compound copies of an available approved drug "regularly or in inordinate amounts"¹.

• FDA treats a compounded product as "essentially a copy" if it has the same active ingredient in the same, similar or easily substitutable strength, given the same way¹.
• Adding another ingredient doesn't automatically change that. FDA's example is semaglutide plus vitamin B12, which it may still treat as a copy¹.
• The exception is when a prescriber decides and documents that a change makes a significant difference for an identified patient¹.
• FDA has said it doesn't intend to act if a pharmacy fills four or fewer prescriptions of a copy in a calendar month¹.

FDA also says retatrutide and cagrilintide can't be used in compounding under federal law. Neither is in an approved drug². See the retatrutide page for its status.

What dosing errors has the FDA seen with compounded GLP-1s?

FDA has reports of overdoses with compounded semaglutide, some needing hospital care. Most involved people drawing up more than the prescribed dose from a multi-dose vial, and some took 5 to 20 times the intended dose³.

• Several people were told to draw 5 units (0.05 mL) on a 1 mL syringe and drew 50 units instead³.
• Prescribers also made errors converting mg to units or mL. One meant to prescribe 0.25 mg (5 units) but wrote 25 units, and the patient had severe vomiting³.
• FDA says confusion between mL, mg and "units", and syringes much larger than the dose, may have contributed³.
• Reported effects included nausea, vomiting, stomach pain, fainting, headache, migraine, dehydration, acute pancreatitis and gallstones³.

FDA has also received reports linked to compounded semaglutide or tirzepatide prescribed above label doses, taken more often, or stepped up faster than the label schedule². As of May 31, 2026, FDA had 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide. FDA says the real numbers are likely higher, because state-licensed pharmacies that aren't outsourcing facilities don't have to report adverse events to it².

What are semaglutide sodium and semaglutide acetate?

They are salt forms of semaglutide that some compounders have used. FDA says they are different active ingredients from the base semaglutide in the approved drugs, and it isn't aware of any lawful basis for compounding with them^2–3.

FDA says it has no information on whether the salts have the same chemical and pharmacologic properties as the approved active ingredient². It has also warned about other quality problems:

• Products that arrived warm or with too little ice. FDA says not to use an injectable GLP-1 that arrives warm².
• Multi-dose vials: FDA recommends throwing them away 28 days after first use, even if the compounder's instructions say longer².
• Fake labels naming pharmacies that don't exist, or that didn't make the product².
• Semaglutide and tirzepatide sold as "for research purposes" or "not for human consumption", which FDA calls illegal².

Are compounded GLP-1s banned in Australia and the UK?

In Australia, yes. From 1 October 2024, medicines containing GLP-1 receptor agonists were removed from the exemption that lets pharmacists compound medicines. The change applies to GLP-1 medicines dispensed or compounded on or after that date⁵.

• The change was made by amending Schedule 5, table item 6 of the Therapeutic Goods Regulations 1990⁵.
• The government said online weight loss clinics with their own pharmacy services had supplied compounded GLP-1s to at least 20,000 patients⁵.
• Its reasons: these are sterile injectables with high-risk active ingredients, and the TGA doesn't evaluate compounded versions or the raw ingredients imported to make them⁵.

In the UK, the MHRA says licensed GLP-1 medicines come only as pre-filled pens or tablets, and products supplied as powder in vials to be mixed before injection "are not authorised and pose significant health risks"⁶. It says the only way to be sure of a genuine product is a legitimate pharmacy with a prescription⁶.

If you're using a compounded product now, check with your prescriber or pharmacist about what you have and how to measure it. For the branded options, see Ozempic vs Wegovy and Mounjaro vs Zepbound.