FDA sets four-prescription cutoff for compounded semaglutide and tirzepatide copies
The clarification tells pharmacies how few copies they can make without drawing FDA action, and shows that adding vitamin B12 may not be enough to set a compounded GLP-1 apart from the approved drug.
The Food and Drug Administration said on April 1, 2026 that it does not plan, at this time, to bring enforcement action against a state-licensed 503A compounder that fills four or fewer prescriptions of a given "essentially a copy" product in a calendar month [1].
The update restates the conditions a compounded drug must meet for the exemptions under sections 503A and 503B of the Food, Drug, and Cosmetic Act to apply [1]. For 503A, that includes making the product for an identified patient against a prescription, and not making essentially copies of a commercially available drug regularly or in inordinate amounts [1].
How the agency draws the line
Two tests define an essentially-a-copy product. The first applies when a compounded drug uses 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 route of administration the prescription calls for, regardless of how the approved product is labeled [1]. That finding does not apply if the prescriber determines and documents that the compounded drug contains a change producing a significant difference for one identified patient [1].
The agency uses the same framework when a compounded drug contains the active ingredients of more than one approved product [1].
The vitamin B12 example
That second test is where the B12 illustration lands. The FDA said it may treat a compounded product that combines semaglutide with vitamin B12 (cyanocobalamin) as essentially a copy when two things are true: both are given the same way — injectables, for instance — and the amounts of semaglutide and vitamin B12 in the compounded product fall within 10% of the strengths of the matching commercially available products [1].
Volume, and the 503B side
The agency's stated position is that it does not intend to act against a compounder for making an essentially-a-copy product regularly or in inordinate amounts when that compounder fills four or fewer prescriptions of the product in a calendar month [1]. How the agency would count or verify those prescriptions is not described in the notice [1].
Outsourcing facilities under section 503B face a separate restriction. They may not compound from bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on the FDA shortage list at the time it is compounded, distributed, and dispensed [1]. Neither tirzepatide nor semaglutide is on either list, the agency said [1].
The tirzepatide injection shortage was declared resolved on December 19, 2024, and the semaglutide injection shortage on February 21, 2025 [1]. The periods when the FDA said it would not act on shortage-related violations closed during 2025: February 18 for 503A tirzepatide, March 19 for 503B tirzepatide, April 22 for 503A semaglutide, and May 22 for 503B semaglutide [1].
Why it matters for patients
Compounded semaglutide and tirzepatide products are not FDA-approved, and the agency says it can still pursue violations of other requirements, including findings that a product is substandard in quality or otherwise unsafe [1]. Nothing in the April notice changes that.
Whether a patient's compounded prescription falls inside the enforcement position the agency described depends on how many prescriptions of that product the pharmacy dispenses in a month. Four or fewer is the figure given; above that, the pharmacy is outside it. The notice names no products or pharmacies, so it does not identify which compounded medicines are covered.
The B12 example speaks to ingredient blends specifically. Under the agency's approach, adding a vitamin is not by itself enough to avoid the essentially-a-copy finding when the strength is within 10% of the approved product and the injection route is the same [1].
What happens next
No new compliance date accompanied the April 1 notice. The discretion periods tied to the shortage listings ended during 2025 [1]. The FDA frames the four-prescription figure as its current intent rather than a change to the statutory conditions [1].
Sources
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