Is compounded tirzepatide still available in 2026?
As of October 2026, compounded tirzepatide is still prescribed and dispensed in the U.S., but the legal ground under it has narrowed sharply since 2024.
What changed
- The shortage ended. FDA declared the tirzepatide shortage resolved on October 2, 2024. Shortage status was what allowed broad compounding of copies.
- Outsourcing facilities stopped. 503B outsourcing facilities, which make larger batches, had to stop compounding tirzepatide from bulk ingredients by March 19, 2025.
- A proposed permanent exclusion. On April 30, 2026, FDA proposed formally excluding tirzepatide, semaglutide, and liraglutide from the 503B bulks list. The comment period has closed; we have not seen a final rule.
- Marketing enforcement. FDA has sent well over 100 warning letters to GLP-1 telehealth marketers since September 2025, including 30 announced in early 2026 and 25 more in June 2026.
- Litigation. The brand manufacturer has sued multiple compounders and telehealth companies.
What is still allowed
A 503A pharmacy may compound a drug for an individual patient based on a prescription when the prescriber determines a compounded version is needed for that patient, for example a different dose or formulation. That patient-specific pathway is what licensed telehealth programs now use. It is narrower than “copies at scale,” and pharmacies and prescribers carry the responsibility to document the need.
What this means for you
- Expect prices and availability to keep moving. Our price table is re-checked daily.
- Choose providers that name their 503A pharmacy and use a real clinician visit.
- Avoid anyone selling tirzepatide “for research” or without a prescription. Those are unapproved drugs, and we do not list or link them.
Safety information
Compounded tirzepatide is not FDA-approved and has not been evaluated by FDA for safety, effectiveness, or quality. Tirzepatide carries risks including nausea, pancreatitis, gallbladder disease, and a boxed warning for thyroid C-cell tumors seen in rodents. Only a licensed clinician can decide whether it is appropriate for you.
Sources
- fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/altru-telehealth-llc-dba-altru-telehealth-728274-06082026
- healthlawalliance.com/blog/tirzepatide-compounding-enforcement
- mcdermottlaw.com/insights/fda-takes-aim-at-misleading-online-claims-for-compounded-glp-1-drugs/
Read next
-
503A vs 503B compounding pharmacies: what the difference means for you
Who makes compounded GLP-1s and peptides, how each type is regulated, and the questions to ask before you fill a prescription.
-
Can a naturopathic doctor prescribe semaglutide or tirzepatide?
In some states yes, in most no. How ND prescribing authority works, which states grant it, and how to keep your ND in charge of the protocol either way.