FDA restates compounding rules, says tirzepatide and semaglutide stay off shortage and bulk lists
The FDA repeated the conditions compounders must meet to copy GLP-1 drugs, a restatement that could affect where patients get compounded tirzepatide or semaglutide.
On April 1, 2026, the Food and Drug Administration restated the rules that let compounding pharmacies make copies of GLP-1 drugs, and confirmed that tirzepatide and semaglutide sit on neither of the two lists that would open a federal pathway for large-scale compounding [1]. Tirzepatide is the molecule in Mounjaro and Zepbound; semaglutide is the molecule in Ozempic, Wegovy and Rybelsus.
The conditions the FDA repeated
Section 503A lets a state-licensed pharmacy or physician compound a drug only when it is made for an identified patient against a prescription, and only when the compounder does not turn out essentially-a-copy products either regularly or in inordinate amounts [1]. The FDA said it reads "essentially a copy" to cover a compounded drug that carries the same active ingredient or ingredients as a commercially available product, in the same, similar or easily substitutable strength, and that can be given by the same route of administration — regardless of how the commercial product's label reads [1]. A prescriber can override that reading by documenting that the compounded version contains a change producing a significant difference for a specific patient [1].
The agency gave a concrete illustration: a compounded injection that pairs semaglutide with vitamin B12 (cyanocobalamin) may count as essentially a copy if it is injected like the brand products and if each ingredient lands within 10% of the strength of the corresponding commercially available product [1].
The FDA also spelled out a narrow enforcement boundary. It said that, at this time, it does not plan to pursue a compounder that produces an essentially-a-copy drug regularly or in inordinate amounts as long as the compounder fills no more than four prescriptions of that product in a calendar month [1]. That figure describes when the agency intends to look the other way. It is not a finding that such products are approved or interchangeable.
For outsourcing facilities operating under section 503B, the agency restated a separate restriction: these operations cannot compound from a bulk drug substance unless that substance is named on the 503B bulks list, or unless the finished drug appears on the shortage list at the moment it is compounded, distributed and dispensed [1]. Neither tirzepatide nor semaglutide meets either condition [1].
How both drugs got here
The FDA declared the tirzepatide injection shortage over on December 19, 2024, and the semaglutide injection shortage over on February 21, 2025 [1]. The grace periods tied to those listings have since lapsed — February 18, 2025 and March 19, 2025 for 503A and 503B compounders working with tirzepatide, and April 22, 2025 and May 22, 2025 for those working with semaglutide [1]. Those timelines followed court rulings: judges in the Northern District of Texas declined to grant preliminary injunctions in Outsourcing Facilities Association v. FDA on March 5, 2025 and April 24, 2025 [1].
Why it matters for patients
Anyone whose GLP-1 prescription is filled by a compounding pharmacy is affected by which list a drug appears on. With both molecules off the shortage list and off the 503B bulks list, large outsourcing facilities have no federal shortage-based cover for making copies [1]. The practical effect is that compounded tirzepatide and semaglutide rest on the narrower 503A patient-by-patient pathway and the four-prescription enforcement stance, rather than on a declared supply emergency.
The FDA kept its other authorities open. It said it can still act on violations of other statutory or regulatory requirements, including concerns that a product is substandard or unsafe [1].
The notice did not discuss pricing, insurance coverage, or whether compounded products can be substituted for FDA-approved ones. None of that has been reported in this action.
What happens next
No new compliance date, deadline or enforcement window came with the April 1 update [1]. The FDA said it continues to monitor drug availability [1]. Whether any compounder or trade group challenges the restated position in court has not been reported.
Sources
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