FDA restates compounding limits for semaglutide and tirzepatide copies

On April 1, 2026, the FDA restated the conditions that compounded GLP-1 drugs must meet, saying that semaglutide and tirzepatide appear on neither the 503B bulks list nor the agency's drug shortage list ^[1]. The agency also said it does not intend to act against a pharmacy that fills four or fewer prescriptions a month for a compounded product that is essentially a copy of an approved drug ^[1].

The FDA described the notice as a reminder of the exemptions under sections 503A and 503B of the Food, Drug, and Cosmetic Act ^[1]. Under section 503A, a compounded drug must be made for an individual patient based on a prescription, and the compounder must not compound an essentially-a-copy product regularly or in inordinate amounts ^[1]. The agency said a compounded product is essentially a copy when it has the same active ingredient as an approved product in the same, similar, or easily substitutable strength, and the approved product can be used by the same route of administration ^[1]. A prescriber can document that a change produces a significant difference for an identified patient ^[1].

The FDA gave vitamin B12 as an example. A compounded injectable that combines semaglutide with vitamin B12 (cyanocobalamin) may still be treated as essentially a copy if it is given the same way as the approved products and the amounts of semaglutide and vitamin B12 are each within 10% of the strengths of the respective commercially available products ^[1].

On volume, the agency said it "does not intend to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug product during a calendar month" ^[1].

For outsourcing facilities under section 503B, compounding with bulk drug substances is restricted unless the substance is on the 503B bulks list or the compounded drug is on the FDA's shortage list at the time of compounding, distribution, and dispensing ^[1]. The FDA said tirzepatide and semaglutide currently appear on neither list ^[1].

That follows earlier shortage decisions. The FDA determined the tirzepatide injection shortage was resolved on December 19, 2024, and the semaglutide injection shortage on February 21, 2025 ^[1]. Enforcement discretion tied to the shortage list ended for 503A compounders of tirzepatide on February 18, 2025, and of semaglutide on April 22, 2025; for 503B outsourcing facilities it ran to March 19, 2025, for tirzepatide and May 22, 2025, for semaglutide ^[1]. On April 28, 2025, the FDA noted that a district court denied a preliminary injunction motion in Outsourcing Facilities Association v. FDA concerning compounded semaglutide ^[1].

Why it matters for patients

People who get compounded semaglutide or tirzepatide depend on the pharmacy that makes their product, and the FDA's stated position ties that pharmacy's room to operate to how many prescriptions of that specific compounded product it fills each month ^[1]. At four or fewer prescriptions a month, the agency has said it does not intend to act on the copy question; above that, that stated discretion would not apply ^[1].

The FDA also said it may still act on other statutory or regulatory violations, such as findings that a product may be of substandard quality or otherwise unsafe ^[1]. The statement addresses compounders, not patients. It does not say patients who received compounded drugs did anything wrong, and it does not address the price of FDA-approved semaglutide or tirzepatide products ^[1]. Whether individual pharmacies will change what they offer or how they price it has not been reported ^[1].

The April 1 notice restates existing conditions rather than setting a new compliance deadline, and no further FDA step on this issue has been announced ^[1].