Compounded GLP-1 Legal Status in 2025: What Patients and Prescribers Need to Know

How the legal rules differ

State-licensed pharmacies and outsourcing facilities follow different federal compounding rules. A state-licensed pharmacy or physician compounds a drug for an identified patient after receiving a prescription. An outsourcing facility is restricted from compounding with a bulk drug substance unless the substance appears on FDA's list of bulk substances for which there is a clinical need, or meets another condition FDA sets [1]. FDA states that tirzepatide and semaglutide do not currently meet those conditions [1].

Compounders challenged FDA's position in Outsourcing Facilities Association v. FDA. A district court denied the preliminary injunction motion on tirzepatide on March 5, 2025, and on semaglutide on April 24, 2025 [1]. FDA then said that the period of enforcement discretion for state-licensed pharmacies compounding semaglutide injection had ended, and that for outsourcing facilities it did not intend to act on certain violations until May 22, 2025 [1].

What a state-licensed pharmacy can still compound

On April 1, 2026, FDA restated the conditions a compounded drug must meet [1]:

• It is compounded for an individual patient based on a prescription.
• The compounder does not compound, regularly or in inordinate amounts, products that are essentially copies of a commercially available drug.

FDA may treat a compounded product as essentially a copy of a commercially available product when it uses that product's API (active pharmaceutical ingredient) in the same, similar or easily substitutable strength and the product can be used by the same route, unless the prescriber documents a significant difference for the individual patient [1]. FDA's own example: a product combining semaglutide with cyanocobalamin (vitamin B12) can be essentially a copy when the amounts of semaglutide and vitamin B12 fall within 10% of the strengths of the marketed products given the same way [1].

FDA also said it does not intend to take action against a compounder that fills four or fewer prescriptions for such a copy during a calendar month [1].

What about outsourcing facilities and the bulk substances list

On April 30, 2026, FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the outsourcing-facility bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances; comments were due June 29, 2026, and FDA said it would consider them before making a final determination [3].

Retatrutide and cagrilintide

FDA states that retatrutide and cagrilintide cannot be used in compounding under federal law, that they are not components of FDA-approved drugs, and that they have not been found safe and effective for any condition [2].

What FDA says about the safety of compounded versions

Compounded drugs are not FDA approved, which means the agency does not review them for safety, effectiveness or quality before they are marketed [2]. As of May 31, 2026, FDA had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide, along with reports of dosing errors [1].

FDA recommends that vials of sterile medication containing multiple doses be discarded 28 days after first use, even if medicine remains, and that a new sterile needle and syringe be used for each dose [2]. FDA states that compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug [2].

Do the published trial results apply to compounded versions?

The weight-loss figures usually quoted come from clinical trials. STEP 1 randomized 1,961 adults with obesity or overweight and no diabetes to semaglutide 2.4 mg or placebo for 68 weeks: mean weight change was -14.9% versus -2.4% [4]. SURMOUNT-1 randomized 2,539 adults to tirzepatide 5, 10 or 15 mg or placebo for 72 weeks: mean weight change was -15.0%, -19.5% and -20.9% versus -3.1% [5]. FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed [2].