For about three years, a line item on a government database was the reason a compounded GLP-1 could be produced for a national market at all. That line item is gone, and the legal ground under most of the sellers whose prices sit on the semaglutide board moved with it. Nothing about the chemistry changed on either date. What changed was a permission.
The list is a legal switch
The FD&C Act requires the agency to maintain an up-to-date list of drugs it determines to be in shortage, and defines a shortage as a period when demand or projected demand for the drug within the United States exceeds supply.[1] The assessment is national and across the whole market rather than local, which is why a resolved shortage and an empty pharmacy shelf are not a contradiction.
Two compounding restrictions hang off that list. Under section 503A, a pharmacy may not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product — and for those purposes the agency does not consider a drug on the shortage list to be commercially available.[1]Under section 503B, an outsourcing facility may compound from a bulk drug substance where the drug appears on the shortage list at the time of compounding, distribution and dispensing, and may not compound a drug that is essentially a copy of an approved drug.[3] While the listing stood, both restrictions were switched off for these molecules.
The dates
Wegovy was added to the shortage list on March 31, 2022 and Ozempic on August 23, 2022.[1] Tirzepatide injection products were first added on December 15, 2022.[2] Those three dates are the beginning of the compounded GLP-1 market as anyone buying today would recognize it.
The agency determined the tirzepatide shortage resolved on October 2, 2024, and the semaglutide shortage resolved on February 21, 2025.[1][2] Each determination rested on data from the manufacturer covering quantities supplied and demanded, inventory held in stock, projected supply and demand, and wholesaler inventory. The semaglutide order records that the agency also weighed material from telehealth companies, pharmacy compounders and their associations, and concluded that it had important limitations that did not outweigh the manufacturer’s data.[1]
The agency has published the factors it weighs before calling a shortage resolved: the company’s ability to meet current and historical demand, the amount in the manufacturer’s stock, affected market share, the ability of alternate manufacturers to cover demand, and confirmed market stabilization.[3] Every one of those is a question about a factory’s output. None of them is a question about what anybody pays, which is why a reader whose own cost did not move on February 21, 2025 was not misreading the announcement.
The tirzepatide decision was made twice
The October 2024 determination did not survive contact with the courts. On October 7, 2024 the agency was sued in the Northern District of Texas by the Outsourcing Facilities Association and a compounding company, and on October 11, 2024, on the agency’s own motion, the court remanded the decision for reevaluation.[2]
On December 19, 2024 the agency issued a new declaratory order that revoked and replaced the October 2 decision and reached the same conclusion: the tirzepatide injection shortage is resolved.[2]A market that had already begun adjusting to the first decision spent eleven weeks in a state where the answer was formally undecided, which is worth remembering whenever a seller describes the regulatory position as settled.
The clocks, and what the courts did to them
Each resolution came with a wind-down. For tirzepatide, the agency stated it did not intend to act against 503A compounding until February 18, 2025, or against outsourcing facilities until March 19, 2025. For semaglutide the equivalent dates were April 22, 2025 and May 22, 2025.[3] Why the second period is longer in both cases is a judgment about the two categories set out in the article on 503A and 503B.
Litigation stretched the first of each pair. The agency tied the 503A end date to the later of the stated date or a district court ruling on a preliminary injunction motion; the tirzepatide motion was denied on March 5, 2025 and the semaglutide motion on April 24, 2025, and the agency recorded that the 503A period had ended in each case.[3]The last of the four clocks expired on May 22, 2025.
What a 503A pharmacy may do now
The permission did not vanish; it narrowed to a determination made one patient at a time. The agency’s current statement sets out the test it applies. A compounded product is treated as essentially a copy where it has the same active ingredient as the commercially available product in the same, similar or an easily substitutable strength, and the commercially available product can be used by the same route of administration prescribed for the compounded product — unless a prescriber determines and documents that the compounded product contains a change producing a significant difference for an identified individual patient.[3]
Then the number that decides whether a business model fits. The agency states that it does not intend to take action against a compounder for compounding an essentially-a-copy product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that product in a calendar month.[3] Four a month is a compounding pharmacy serving the occasional patient an approved product does not suit. It is not a subscription sold to a national audience, and the gap between those two pictures is the whole commercial story of this market since 2025.
Three words in the test carry the weight, and they are easy to skate past. The change must produce a significant difference; the difference must be for an identified individual patient; and a prescriber must determine and document it.[3] A strength selected from a menu at checkout, or a product line described as personalized in marketing copy, is none of those three things on its own. Whether a given service’s intake produces that determination is a question about the consultation rather than about the vial, and it is the question a buyer is least equipped to audit from outside.
What an outsourcing facility may do now
Less, and the reason is arithmetic rather than judgment. A 503B facility may compound from a bulk drug substance only where the substance is on the list of substances for which there is a clinical need, or where the drug compounded from it is on the shortage list at the time. The agency states plainly that tirzepatide and semaglutide do not currently appear on the 503B bulks list or on the shortage list.[3] Neither door is open.
The workarounds, and where each one lands
The obvious response to a copies rule is to make the product different, and the agency has addressed the common attempts directly. A compounded product combining semaglutide with another active ingredient such as vitamin B12 may still be treated as essentially a copy where the route is the same and the amounts of each are within 10% of the strengths of the respective commercially available products, absent a documented prescriber determination.[3] Salt forms are a separate dead end: semaglutide sodium and semaglutide acetate are different active ingredients from the one in the approved drugs, and the agency says it is not aware of any lawful basis for their use in compounding.[4] That distinction is unpacked in the article on what a vial contains.
Newer molecules are barred outright rather than restricted. Retatrutide and cagrilintide cannot be used in compounding under federal law and are not components of approved drugs, and the agency has warned telehealth companies marketing retatrutide, active ingredient distributors selling it to compounders, and outsourcing facilities repackaging it.[4] At the border, a green list import alert covers GLP-1 active ingredients with potential quality concerns while leaving imports from apparently compliant manufacturers untouched, and the agency states it creates no new limits on lawful compounding.[4]
A 2026 clinical report describes where the pressure has gone instead: affordability barriers driving unsupervised strategies, including subtherapeutic microdosing and the purchase of illicit “research-grade” peptides from online sources, as the window for mass compounding closes.[5] The dosing half of that is in the microdosing article and the sourcing half in what testing has found in illicit-market product.
What the resolution did not change
It was a finding about supply, not about quality. Compounded drugs remain outside the approval system: they are not FDA-approved, and the agency does not review them for safety, efficacy or quality before they are dispensed — which is what that sentence is doing on every page here, as the article on the approval language sets out. A resolved shortage says the manufacturer can meet national demand. It says nothing about whether a given person can afford the approved product, and the agency itself allows that intermittent localized disruptions continue after a resolution.[1]
Nor does it settle the price question, which runs on patents rather than on shortages and is tracked in the article on patent expiry. What the last four years established is narrower and easy to state: for this drug class, the difference between a lawful national compounding industry and an unlawful one was a database entry, and the entry is no longer there.