Which Telehealth Companies Can Legally Sell Compounded Tirzepatide in 2026?
Which telehealth companies legally sell compounded tirzepatide in 2026?
Published September 2, 2026
Key takeaways
- The FDA declared the tirzepatide shortage resolved on December 19, 2024, and the semaglutide shortage resolved on February 21, 2025 — both by formal Declaratory Order.
- Once a shortage is resolved, federal law restricts 503A pharmacies from compounding a drug that is 'essentially a copy' of the now-available commercial product.
- Legal compounding after a shortage resolves requires a documented, individualized clinical reason — a non-standard dose or formulation the commercial product doesn't offer — not just cost or availability.
- In February 2026, the FDA issued warning letters to roughly 30 telehealth companies over marketing that implied their compounded products were equivalent to FDA-approved medications.
- The FDA has separately proposed removing semaglutide, tirzepatide, and liraglutide from the substances 503B outsourcing facilities are permitted to compound in bulk.
Mazrek
Physician-reviewed GLP-1 care
- State-licensed compounding pharmacy partner
- Certificate of analysis provided per batch
- Every prescription reviewed by a licensed provider
- Unlimited care team messaging
Prescription required. Treatment is only provided if clinically appropriate, as determined by a licensed provider.
The rule that actually changed
For most of 2023 and 2024, compounded semaglutide and tirzepatide were widely available because both drugs were on the FDA's official drug shortage list — a status that lets compounding pharmacies fill the gap. That changed on two specific dates: the FDA issued a Declaratory Order resolving the tirzepatide shortage on December 19, 2024, and did the same for semaglutide on February 21, 2025.
Once FDA declares a shortage resolved, the underlying law — Section 503A of the Federal Food, Drug, and Cosmetic Act — restricts state-licensed pharmacies from compounding a version that is "essentially a copy" of the now-commercially-available product. In plain terms: a pharmacy can no longer compound a standard dose of tirzepatide or semaglutide just because it's cheaper or more available than the brand-name version.
What's still legal
Patient-specific compounding under 503A remains legal, but the bar is narrower than it was during the shortage. It requires a prescriber to document a real, individualized reason the commercial product doesn't work for that specific patient — for example, a dose or strength the manufacturer doesn't produce, or a formulation change needed for a documented allergy. "It's less expensive" or "it was easier to get" isn't that reason.
Separately, the FDA has proposed excluding semaglutide, tirzepatide, and liraglutide from the list of substances 503B outsourcing facilities can compound in bulk — a category of compounding that operates differently from patient-specific 503A pharmacies and doesn't require an individual prescription up front.
What this means for evaluating any provider
The FDA has been actively enforcing this line: in February 2026, it sent warning letters to roughly 30 telehealth companies over marketing language that implied compounded GLP-1 products were equivalent to the FDA-approved originals — a claim the agency considers misleading, since compounded drugs are not FDA-reviewed for safety, effectiveness, or quality.
Rather than treating "legal" as a fixed list of company names — which changes as enforcement continues — the more durable question to ask any provider is:
- Is my prescription being written for an individualized clinical reason, not just cost or convenience?
- Is the pharmacy filling it a 503A pharmacy compounding against my specific prescription, not a bulk 503B facility?
- Does the provider's marketing avoid claiming their compounded product is equivalent to the FDA-approved brand?
A provider that can answer all three clearly is operating inside the current legal framework. One that can't, or won't say, is the kind of marketing the FDA flagged in February 2026.
Frequently asked
Does the shortage being over mean compounded tirzepatide is illegal now?+
No — it means the legal basis narrowed. Routine compounding of a dose or formulation that's essentially a copy of the commercial product is no longer covered by the shortage exception. Patient-specific compounding under Section 503A remains legal when a prescriber documents an individualized clinical reason the commercial product doesn't meet that patient's needs.
What's the difference between a 503A and a 503B compounding pharmacy?+
A 503A pharmacy compounds against a specific prescription for a named, individual patient. A 503B outsourcing facility compounds in bulk batches without a patient-specific prescription and is regulated more like a manufacturer. The FDA has proposed excluding semaglutide, tirzepatide, and liraglutide from the list of substances 503B facilities can compound entirely.