Is Compounded Semaglutide or Tirzepatide Still Legal in 2026?

Compounding pharmacies were allowed to make copies of semaglutide and tirzepatide while the brand drugs were on FDA’s shortage list. FDA declared the tirzepatide shortage resolved on December 19, 2024 and the semaglutide shortage resolved on February 21, 2025 (FDA).

As of FDA’s April 1, 2026 update, neither drug is on the shortage list or on the 503B bulks list (FDA). Routine copies are no longer permitted; narrow exceptions remain for individual patients. Regulatory facts are not graded; the FDA-approved versions rest on Evidence: A (large randomized trials, see the reference pages linked below).

Source: FDA’s compounder policy page and its semaglutide declaratory order (FDA; FDA order).

Under section 503A, a pharmacy may not regularly compound “essentially copies” of a commercially available drug. FDA treats a compounded product as a copy when it has the same active ingredient in the same, similar or easily substitutable strength and can be used by the same route, unless a prescriber determines and documents a change that makes a significant difference for an identified patient (FDA).

FDA’s April 2026 update says adding vitamin B12 does not by itself avoid this: a semaglutide-plus-B12 injection can still count as a copy when both amounts are within 10% of approved products. FDA also said it does not intend to act against a pharmacy that fills four or fewer prescriptions of such a copy in a calendar month (FDA).

Outsourcing facilities may compound from bulk ingredients only if the ingredient is on the 503B bulks list or the drug is in shortage. On May 1, 2026, FDA proposed not to add semaglutide, tirzepatide or liraglutide to that list, finding no clinical need (Federal Register). FDA extended the comment period in June 2026; as of October 9, 2026 we found no final decision in the Federal Register.

FDA-approved versions are the default route: see semaglutide and tirzepatide. For how compounded products differ from the brand drugs, see compounded semaglutide vs Wegovy vs the pill and 503A vs 503B pharmacies.