Semaglutide: FDA status, 503A compounding, and where we stand

Semaglutide is approved by the FDA and marketed as Ozempic and Rybelsus for type 2 diabetes and as Wegovy for chronic weight management. Approved products are commercially available.

FDA declared the semaglutide shortage resolved in February 2025. With no shortage in effect and an approved product on the market, the compounding allowances that applied during the shortage no longer apply.

On April 1, 2026, FDA clarified how it applies the "essentially a copy" test under section 503A. A compounded product is considered essentially a copy when it contains the same active pharmaceutical ingredient as a commercially available product by the same route of administration. FDA's own published example is a semaglutide and vitamin B12 combination: where each active ingredient falls within 10 percent of the commercially available strength, adding a second ingredient does not by itself move the product outside the restriction.

On April 30, 2026, FDA proposed permanently excluding semaglutide, tirzepatide and liraglutide from the 503B bulk drug substances list, having found no sufficient clinical need for outsourcing facilities to compound them from bulk.

On September 18, 2026, FDA issued a Warning Letter to a large compounding pharmacy over semaglutide and tirzepatide combination products. FDA's position was that the added ingredients were pretextual. It pointed to significant-difference language repeated verbatim across patient records, and to third-party platforms presenting pre-selected combination options, as evidence that individualized determinations were not genuinely being made.

This is the question we are asked most, so we will answer it plainly. Combining semaglutide with another substance is not a general compounding pathway. Section 503A permits a compounded product that would otherwise be a copy only where the prescriber determines and documents that a change produces a significant difference for an identified individual patient. That determination is clinical, it is specific to one person, and it belongs in that person's chart. A standing formulation offered from a menu is not an individualized determination.

Our physicians prescribe compounded semaglutide where section 503A provides for it: as a patient-specific preparation, dispensed pursuant to a prescription for an identified individual patient, where the prescriber has determined and documented that the change produces a significant difference for that patient. A documented excipient allergy meets that standard. So does a strength that is not commercially available. Cost does not — price is not a clinical difference, and the standard does not recognize it as one. What we do not do is present it for selection. There is no listing to browse, because the determination comes first: the preparation is compounded for one identified patient after a prescriber documents the clinical reason, and a licensed 503A pharmacy dispenses it. It appears on your order at that point. The prescription originates the order, never the reverse.

Whether such a prescription can actually be filled depends on more than the prescriber's judgment. FDA applies a second, separate limit on compounding a product regularly or in inordinate amounts, and has said it does not currently intend to act against a compounder filling four or fewer prescriptions of the same compounded product in a calendar month, with each refill counted separately. That limit sits alongside the documentation requirement rather than being satisfied by it. State boards of pharmacy also retain independent authority regardless of FDA's position, and several states are stricter than the federal standard. Because we are licensed nationwide, the answer depends on the state you are treated in and on the pharmacy filling the prescription.

If GLP-1 therapy is clinically appropriate for you, the FDA-approved products are available by prescription, and our physicians prescribe them.