Every regulatory, legal and safety event that changes what compounded tirzepatide and semaglutide providers may sell, in date order, with its current status and source. Entries marked reported have not yet been checked against the primary document. FDA warning letters to specific providers or pharmacies will be listed in their own section as they are captured; none has been recorded yet.
Timeline
- March 31, 2022 — FDA adds semaglutide injection to the drug shortage list. Status: historical. Source: FDA drug shortage database.
- December 15, 2022 — FDA adds tirzepatide to the drug shortage list. Status: historical. Source: FDA drug shortage database.
- July 26, 2024 — FDA alerts on dosing errors with compounded injectable semaglutide (patients taking 5 to 20 times the intended dose). Status: current. Source: FDA safety communication.
- October 2, 2024 — FDA removes tirzepatide from the shortage list; compounders' association sues; FDA agrees to reconsider. Status: historical. Source: FDA; N.D. Tex. docket.
- December 19, 2024 — FDA confirms the tirzepatide shortage resolved; enforcement discretion to 2025-02-18 (503A) and 2025-03-19 (503B). Status: current. Source: FDA clarification.
- February 21, 2025 — FDA declares the semaglutide shortage resolved; grace periods to 2025-04-22 (503A) and 2025-05-22 (503B). Status: current. Source: FDA announcement.
- April 23, 2025 — Eli Lilly files suits against Mochi Health, Fella Health, Henry Meds and Willow over compounded tirzepatide marketing and 'personalized' dosing. Status: pending litigation. Source: Federal court filings.
- November 6, 2025 — Manufacturer pricing agreements announced: Medicare obesity pathway at $245, TrumpRx direct pricing, Zepbound and Wegovy cash-price cuts. Status: implementation ongoing. Source: White House; manufacturer statements.
- December 22, 2025 — Oral Wegovy (semaglutide tablets) approved; NovoCare self-pay pricing published. Status: current. Source: FDA approval; NovoCare.
- April 30, 2026 — FDA proposes removing tirzepatide from the 503B bulk drug substances list; comment period through 2026-06-29 (reported; not yet checked against the Federal Register). Status: reported; proposed rule. Source: Third-party comparison page, June 2026.
- May 31, 2026 — FDA reports 990 adverse-event reports associated with compounded semaglutide and more than 730 with compounded tirzepatide, as of this date. Status: current. Source: FDA: concerns with unapproved GLP-1 drugs (verified 2026-08-25).
FDA warning letters to GLP-1 providers and pharmacies
None recorded yet.
How to check a warning letter yourself
The FDA's warning-letter database is searchable by company name; search the pharmacy named by your provider and the provider's corporate name. A warning letter is an allegation that the company may answer; it is not a finding, but it is a fact worth knowing before paying. The legality article and the 503A/503B guide explain the rules the letters enforce.
Frequently asked questions
Is compounded tirzepatide legal in 2026?
Lawful when compounded for a specific patient with a documented clinical rationale for a product that differs from Zepbound; compounding copies has been unlawful since the shortage grace periods ended in February and March 2025. The timeline lists each step.
Is compounded semaglutide legal in 2026?
On the same basis: the semaglutide shortage was declared resolved on February 21, 2025, with 503A pharmacies given until April 22 and 503B facilities until May 22, 2025 to stop compounding copies. Patient-specific compounding with a documented rationale remains lawful; salt forms (semaglutide sodium or acetate) have no lawful basis per the FDA.
Is compounded GLP-1 FDA approved?
No. Compounded drugs are not reviewed by the FDA for safety, effectiveness or quality before they reach patients. The approved products are Zepbound, Mounjaro, Wegovy, Ozempic and oral Wegovy.
What does 'essentially a copy' mean?
A compounded drug with the same active ingredient, route, dosage form and strength as an approved product, or within 10% of its strength, unless the prescriber documents a significant clinical difference for the patient. Cost is not a qualifying difference; a documented allergy to an inactive ingredient can be.
Can pharmacies add B12 or glycine to tirzepatide to make it different?
The FDA has said an additive does not by itself take a product outside the copy rule if the active strength and route match, and Eli Lilly's 2025 suits allege that vitamin-added 'personalized' formulations are pretexts. A documented clinical reason for the addition is the standard; marketing is not.
Are personalized doses and microdoses legal?
A non-standard strength prescribed for a documented, patient-specific reason can be lawful; a microdose protocol sold from a homepage before any clinician has seen the patient is what the litigation contests. Neither has trial evidence.
Are oral or sublingual compounded GLP-1s FDA approved?
No, and there is no published absorption evidence for them. Oral Wegovy (semaglutide tablets) is the only approved oral GLP-1 for weight management.
Does the FDA inspect compounding pharmacies?
503B outsourcing facilities are FDA-registered and inspected. 503A pharmacies are state-licensed and inspected by state boards, with FDA involvement mainly through warning letters and referrals.
What is LegitScript certification, and does it mean a provider is safe?
A private certification that a telehealth or pharmacy website meets legal and transparency standards, used by advertising platforms to gate ads. It is a meaningful signal about legitimacy and disclosure, not a clinical quality assurance and not an FDA status.
How do I check for an FDA warning letter?
Search the FDA warning-letter database by the pharmacy's or company's name. A warning letter is an allegation the company may answer, not a finding, but it is worth knowing before paying. We will list letters to GLP-1 providers and pharmacies on this page as they are captured.
Has the FDA sent warning letters to GLP-1 telehealth providers?
We have not yet captured specific letters in this tracker; the FDA's database is searchable by company name and the page explains how to use it.
What changed in 2026?
A reported FDA proposal (April 30, 2026) to remove tirzepatide from the 503B bulk list, and FDA adverse-event counts of 990 (semaglutide) and more than 730 (tirzepatide) reports as of May 31, 2026.