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GLP‑1 supply & legality: what’s in shortage, what’s legal to compound

FDA shortage status per molecule and whether compounding it is lawful, with the date each grace period closed and what that means before you buy.

Is it in shortage — and is compounded legal? · Data: FDA shortage database · FDA compounding actions · Checked August 27, 2026
Pick a molecule
Status shown as of August 27, 2026.

“In supply” is FDA’s national designation — local stockouts still happen, which is why the cash programs that ship direct rarely miss fills.

Semaglutide (Wegovy, Ozempic, Rybelsus)
per FDA records, checked August 27, 2026
FDA shortage status
In supply
since Feb 21, 2025
Compounded copies
Copies not permitted
since May 22, 2025

FDA removed injectable semaglutide from the drug shortage list on Feb 21, 2025; supply has held through 2026. Grace periods for making copies of approved semaglutide ended Apr 22, 2025 (503A pharmacies) and May 22, 2025 (503B outsourcing facilities). Court challenges to the delisting did not restore them [VERIFY current appeals].

What this means if you’re buying

Brand is reliably fillable, and the cash programs ship direct. Compounded semaglutide is lawful only as a clinically necessary personalized formulation — a prescriber-documented change a brand product can’t satisfy — so volume sellers of near-copies operate in FDA enforcement territory. The safety register checks each program’s pharmacy posture.

Source: FDA drug shortage database · FDA compounding announcements · statuses re-verified on every site update
The timeline that decided today’s rules
FDA shortage database + compounding guidance
Dec 19, 2024
FDA declares the tirzepatide shortage resolved — the first domino
Feb 21, 2025
Semaglutide comes off the shortage list; grace periods start running
Mar–May 2025
Copy exemptions close: tirzepatide Mar 19, semaglutide May 22 (503B)
Aug 27, 2026
Both in supply; only personalized formulations lawful to compound
503A = state-licensed compounding pharmacies (patient-specific scripts). 503B = FDA-registered outsourcing facilities (bulk). During a listed shortage both may compound “essentially a copy” of the brand; once resolved, only clinically necessary personalized formulations remain lawful.

How this tracker works

Supply status is read from the FDA drug shortage database, the legal trigger everything else hangs on: while a drug is listed, federal law lets compounders make what is “essentially a copy” of it; when it delists, grace periods run out and the copy exemption closes. Compounding deadlines come from FDA’s own declined-enforcement announcements for each molecule.

What remains lawful after delisting is the personalized-formulation route: a prescriber documents why a modified strength, additive or dosage form is clinically necessary for a specific patient. FDA and state boards have pursued sellers of near-copies past the deadlines; litigation over the delistings failed to restore them. That is regulatory posture, not settled bright-line law — which is why the register grades each program’s pharmacy documentation rather than declaring anyone legal.

Limits: this page tracks federal status; a few states restrict GLP-1 compounding further. Statuses are re-verified on every site update and the as-of date is printed on every card. None of this is legal advice.

Reading a program’s legal posture — three checks
1
Named pharmacy, verifiable license
The program says which 503A/503B fills its scripts, and the license checks out with the state board.
2
A documented clinical rationale
Personalized dosing prescribed for a stated reason — not a brand copy at a discount with paperwork bolted on.
3
No FDA warning letters on file
The register cross-checks warning letters and import alerts — the provider safety checker automates this next.

Legality questions, answered directly

Copies of the brand are no longer permitted — that exemption died with the shortage listing in 2025. Personalized formulations a prescriber documents as clinically necessary remain lawful under federal compounding law. The distinction is documentation, which is exactly what the safety register grades.

This tracker summarizes public FDA records and is not legal advice; enforcement posture can change faster than any tracker. If your medication supply is interrupted, talk to your prescriber before switching sources.

Data sources · cited with retrieval dates

NADAC figures are pharmacy acquisition costs, not retail prices and not what you will pay. This content is educational and is not medical advice.

The data behind this tool · 8 pages