A U.S. supply guide · Read on 27 October 2026
The shortage years had several turning points
The shortages began at different times. So did the decisions and wind-down periods that followed.
Why the shortage list mattered
The story has three parts: shortages began, compounding had more room, then shortages ended. The last part changed the rules again.
A shortage listing can relax some limits on compounded copies. Other conditions still apply, and compounded medicines are not FDA-approved. That distinction is the thread through this calendar.
2022 made supply a daily question
Semaglutide enters the record
Semaglutide injections sold as Wegovy entered the list in March; Ozempic, also semaglutide, followed in August. FDA’s later order records both dates. Even these two versions of the same medicine had different starting dates.
Tirzepatide joins the shortage story
FDA’s tirzepatide order dates the first listing to this day. Their later decisions and wind-down dates differed too.
The shortage findings change
A decision, then another look
FDA first declared the tirzepatide injection shortage resolved. On 22 October, during a court case, the decision went back to FDA for another look.
The replacement decision
FDA’s new order replaced the October decision and again found the shortage resolved. The shortage-based compounding exceptions would now wind down.
Semaglutide reaches its turning point
FDA found national supply could meet demand, including projected demand. It also acknowledged local delays could continue. A national finding couldn’t settle every household’s next week.
Plans kept moving around the dates
The numbers are sections of federal drug law. 503A covers compounding for individual prescriptions by licensed pharmacists or physicians. 503B covers registered outsourcing facilities that make batches of sterile (germ-free) medicines, with or without individual prescriptions.
FDA’s 2025 updates set out the transition dates. The initial 503A windows were 60 days: 18 February for tirzepatide and 22 April for semaglutide. FDA later confirmed those periods had ended after court rulings on 5 March and 24 April, respectively.
The 90-day 503B dates were 19 March for tirzepatide and 22 May for semaglutide. These windows covered specified shortage-related violations. FDA could still act over other problems, including unsafe medicines.
The 503B transition concerned batch compounding at outsourcing facilities. Other safety duties remained in place through the wind-down.
The later policy belongs to its own date
In its April update, FDA said neither medicine was on the shortage list or the 503B bulks list. That closed the 503B route for making them from raw ingredients.
Under 503A, a changed preparation isn’t treated as a copy if the prescriber determines and documents that the change makes a significant difference for that patient. Other conditions still apply; an ended shortage alone isn’t a reason for compounding.
Sources for this reading
- Declaratory Order: Resolution of Shortages of Semaglutide Injection Products
- Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products
- FDA’s shortage and compounding timeline
- Compounding when Drugs are on FDA’s Drug Shortages List
Read on 27 October 2026. All readings and their context.