FDA sets four-prescriptions-a-month threshold for compounded semaglutide and tirzepatide copies

The Food and Drug Administration said on April 1, 2026 that it does not intend to take action against a compounder that fills four or fewer prescriptions in a calendar month of a drug that is essentially a copy of a commercially available product, and it restated that tirzepatide and semaglutide appear on neither its drug shortage list nor its 503B bulks list ^[1].

Under section 503A of the Food, Drug, and Cosmetic Act, a compounded drug qualifies for the law's exemptions only if it is compounded for an individual patient based on a prescription, and only if the compounder does not compound, regularly or in inordinate amounts, products that are essentially copies of a commercially available drug ^[1].

The agency said it considers a compounded product essentially a copy when it contains the same active ingredient as an approved product in the same, similar, or easily substitutable strength and the approved product can be given by the same route of administration, regardless of how it is labeled ^[1]. There is an exception when a prescriber determines and documents that the compounded product contains a change producing a significant difference for an identified individual patient ^[1]. FDA added that a compounded product can also be essentially a copy of two or more commercially available products under the same kind of test ^[1].

FDA gave an example that applies directly to GLP-1 drugs: a compound that combines semaglutide with vitamin B12 (cyanocobalamin) may be considered essentially a copy when it is given by the same route as the approved products and the amounts of semaglutide and vitamin B12 are within 10% of the strengths of the respective approved products ^[1].

The agency also restated the rules for outsourcing facilities under section 503B. Those facilities may not compound using bulk drug substances unless the substance is on the 503B bulks list or the compounded drug is on FDA's shortage list at the time it is compounded, distributed, and dispensed ^[1]. Neither tirzepatide (sold as Mounjaro and Zepbound) nor semaglutide (sold as Ozempic, Wegovy, and Rybelsus) is on either list, FDA said ^[1]. The agency noted it can still act on other violations, such as products found to be of substandard quality or otherwise unsafe ^[1].

Both brand-name shortages have already been declared resolved. FDA said the tirzepatide injection shortage was resolved on December 19, 2024, and the semaglutide injection shortage on February 21, 2025 ^[1]. The enforcement discretion periods tied to those shortages have since run out: for tirzepatide, until February 18, 2025 for 503A compounders and March 19, 2025 for 503B outsourcing facilities; for semaglutide, until April 22, 2025 for 503A and May 22, 2025 for 503B ^[1]. Those dates followed court rulings that denied preliminary injunctions sought by compounding groups ^[1].

Why it matters for patients

The practical effect is that compounded semaglutide and tirzepatide now sit in a narrower lane than they did during the shortages. A patient-specific prescription with a documented clinical difference from the approved product is the path FDA describes for 503A compounding, and the agency has said it will not prioritize enforcement against compounders filling four or fewer prescriptions a month of a copy ^[1].

The four-prescription figure is a stated enforcement intention, not a license to sell copies at scale. It is also tied to a single compounded drug product per calendar month, so it does not describe a total across a pharmacy's whole business ^[1].

For people receiving a compounded GLP-1, the sourcing question matters more than the label. FDA's 503B position means outsourcing facilities cannot rely on the shortage list or the bulks list to make these products, and the agency says it can still pursue quality or safety problems in any compounded product ^[1]. Details such as whether a particular pharmacy is operating under 503A or 503B, and what a prescriber has documented, are not visible on a vial.

What happens next

No new compliance deadline was announced with the April 1, 2026 statement. FDA said it does not intend to take action on the four-or-fewer-prescription scenario "at this time," language that leaves the position open to change ^[1]. It has not been reported whether the agency plans to put the four-prescription threshold into formal guidance, and no date for that has been disclosed ^[1].