In narrow circumstances, yes, but the shortage-era latitude to copy the approved product ended in March 2025. FDA declared the tirzepatide injection shortage resolved on December 19, 2024, and said it would hold off on enforcement for 60 days for state-licensed pharmacies and 90 days for outsourcing facilities [1]. A pharmacy may still compound tirzepatide for an individual patient’s prescription, within limits FDA spelled out again on April 1, 2026.
Compounded tirzepatide was never FDA-approved, in the shortage or after it, and that has not changed [3]. What changed is how much of it the law allows, and who may make it. The practical question for a buyer is whether the product on offer fits one of the remaining routes. The post-shortage market is described in the 75-clinic study of where compounded supply comes from now. What follows is FDA’s stated position, not legal advice.
Two kinds of compounder, two sets of rules
Federal law recognizes two routes. A licensed pharmacist in a state-licensed pharmacy, or a physician, compounds under section 503A of the Federal Food, Drug, and Cosmetic Act, with day-to-day oversight from the state board of pharmacy [3].
An outsourcing facility registers with FDA under section 503B, is inspected by FDA on a risk-based schedule, and must meet current good manufacturing practice requirements that 503A pharmacies do not [3]. The two routes lost their shortage-era latitude on different terms, which is why the dates below come in pairs.
How the shortage ended, date by date
On October 2, 2024, FDA determined that the tirzepatide injection shortage, in place since 2022 because of increased demand, had been resolved [1]. On October 22, 2024, it reported that the decision had been remanded to the agency for reevaluation as part of litigation.
On December 19, 2024, FDA issued a new decision that the shortage was resolved [1]. To avoid disrupting treatment, it said it did not intend to take action against 503A pharmacies until February 18, 2025, or against 503B outsourcing facilities until March 19, 2025.
On February 11, 2025, FDA tied those dates to a pending court decision in Outsourcing Facilities Association v. FDA, whichever came later [1]. The district court denied the preliminary injunction on March 5, 2025. FDA then stated that the enforcement grace for 503A compounding had ended, and that for outsourcing facilities it ran until March 19, 2025.
What a 503A pharmacy may still do
FDA restated the conditions on April 1, 2026 [1]. A 503A drug must be compounded for an individual patient on receipt of a prescription. The compounder may not make, regularly or in inordinate amounts, products that are essentially copies of a commercially available drug.
FDA treats a compounded product as essentially a copy when it has the same active ingredient in the same, similar or an easily substitutable strength. The second condition is that the approved product can be used by the same route [1]. The exception is a prescriber who determines and documents that a change makes a significant difference for an identified patient.
FDA also stated that it does not intend to take action where a compounder fills four or fewer prescriptions of an essentially-copy product in a calendar month [1]. That is an enforcement intention stated by the agency, not a quantity written into the statute.
Adding an ingredient does not automatically make a product different. FDA’s own example is a semaglutide injection combined with vitamin B12, which it may treat as essentially a copy when both amounts are within 10% of approved products given the same way [1]. Why sellers add B12 in the first place is covered in why compounded semaglutide is mixed with B12.
What an outsourcing facility may still do
A 503B facility may compound from a bulk drug substance only if that substance is on the 503B bulks list. The other route is for the finished drug to be on FDA’s shortage list when it is compounded, distributed and dispensed [1]. FDA stated on April 1, 2026 that tirzepatide appears on neither list.
On April 30, 2026, FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, after finding no clinical need for outsourcing facilities to compound them from bulk [2]. It invited comments through June 29, 2026 and said it would consider them before a final determination.
What the market looked like after the change
Compounding did not stop when the shortage ended. A search of compounding websites in February and March 2025 identified 33 semaglutide or tirzepatide products that differed from the approved ones, and one-third of them contained tirzepatide [4].
Nearly half, 48%, combined the drug with other ingredients such as cyanocobalamin, glycine, niacinamide, docusate or ondansetron [4]. The reviewers found little justification for adding nutrients or docusate, and concluded that safety and efficacy evidence for these products is lacking.
One combination has been tested for quality. Authors affiliated with Eli Lilly, which makes Zepbound and Mounjaro, analyzed compounded tirzepatide with B12 bought in the U.S. market [5]. They reported a widespread impurity formed by a reaction between tirzepatide and certain B12 analogs, whose clinical effects are unknown.
Why the record matters to a patient
During the shortage years, compounded use often sat outside the patient’s regular care. In a primary care database of 153,044 patients on semaglutide or tirzepatide from 2021 through 2024, 8.2% had compounded use documented in their records [6].
Surveys had put the share receiving these drugs from compounders at about 23%, and the authors concluded that many patients may be getting them outside coordinated care [6]. A physician who does not know which product a patient uses cannot judge its dose, and dosing is where the harms in the overdose reports on compounded semaglutide arose. The reporting-odds data are in the FAERS analysis of compounded GLP-1 reports.
A legal review written for compounders put the exposure plainly. Both compounders and clinical practices face significant legal risk from compounding and selling analogs of branded products, and that risk varies by jurisdiction and changes quickly [7]. The authors advised jurisdiction-specific counsel for anyone considering it.
For a buyer, the questions that follow are practical. Which pharmacy made the product, is it a 503A pharmacy or a 503B facility, and how does the product differ from Zepbound or Mounjaro? Whether the approved drug is worth its price over semaglutide is covered in whether tirzepatide is worth the extra cost.