Answer
Say that the drug is compounded, that compounded drugs are not FDA-approved, and that a licensed clinician decides whether it is right for the patient. Do not tie it to a brand such as Ozempic, Wegovy or Mounjaro, and do not give it or its pharmacy an FDA status. FDA posted 113 warning letters to telehealth companies in three batches (9 September 2025, 20 February 2026, 8 June 2026), and 153 of the 255 marketing lines they quote name a brand-name drug.
FDA posted 113 warning letters to telehealth companies about how they market compounded drugs, in 3 batches (9 September 2025 to 8 June 2026):
The letters quote 255 lines of marketing, counting a line each time a letter quotes it (235 different lines). 153 of them name a brand-name drug, and 46 give the drug, a pharmacy or a facility an FDA status (“FDA-approved”, “FDA-registered” and the like). Each line below is FDA’s quotation, with any company name taken out, and the date of the letter it is from.
FDA publishes every letter in its warning-letter index, where these carry “(Telehealth)” in the subject. We do not name the companies, so each quote links that index rather than the letter.
“The same active ingredient as Wegovy and Ozempic”FDA warning letter, 9 September 2025
“Same active ingredient as Ozempic and Wegovy”FDA warning letter, 9 September 2025
“The same active ingredient in Mounjaro and Zepbound”FDA warning letter, 9 September 2025
What FDA wrote in the same batch of letters (9 Sep 2025): “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.”
Example of wording that drops the claim: Compounded semaglutide, prescribed by a licensed clinician when appropriate. Compounded drugs are not FDA-approved and are not the same as any brand-name medicine.
“Mounjaro’s compounded version- Tirzepatide Prescription”FDA warning letter, 9 September 2025
“Ozempic’s compounded version- Semaglutide”FDA warning letter, 9 September 2025
“Semaglutide is the generic drug in Ozempic (injectable) and Rybelsus (oral) diabetes control medications, and Wegovy (injectable) weight loss medication.”FDA warning letter, 9 September 2025
What FDA wrote in the same batch of letters (9 Sep 2025): “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.”
Example of wording that drops the claim: Compounded tirzepatide (not a generic and not FDA-approved).
“Semaglutide (similar to Ozempic) 2.5 mg vial”FDA warning letter, 9 September 2025
“Tirzepatide (similar to Mounjaro) 10 mg vial”FDA warning letter, 9 September 2025
“5 mg of semaglutide comparable to Ozempic. [sic]”FDA warning letter, 9 September 2025
What FDA wrote in the same batch of letters (9 Sep 2025): “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.”
Example of the change: Remove the brand comparison. Describe the compounded drug by its own name, dose form and the fact that it is compounded.
“Ozempic (semaglutide) injection (4 weeks supply)”FDA warning letter, 9 September 2025
“Ozempic (semaglutide) injection (10 weeks supply)”FDA warning letter, 9 September 2025
“Tirzepatide (Zepbound)….”FDA warning letter, 9 September 2025
What FDA wrote in the same batch of letters (9 Sep 2025): “Compounded drug products are not FDA-approved. Your claim implies that your products are the same as an FDA-approved product when they are not.”
Example of wording that drops the claim: Compounded semaglutide injection, 2.5 mg vial.
“Though they contain the same active ingredient as branded Mounjaro and Zepbound, compounded versions are much more affordable, so you win!”FDA warning letter, 9 September 2025
“Though they contain the same active ingredient as branded Ozempic and Wegovy, compounded versions are much more affordable, so you win!”FDA warning letter, 9 September 2025
“Yes, Semaglutide is the active ingredient in Ozempic and Wegovy, a medication commonly used to manage type 2 diabetes and support weight loss. If you’re looking for an affordable alternative, consider trying our compounded Semaglutide. It offers the same effective ingredient as Ozempic and Wegovy, but at a fraction of the price.”FDA warning letter, 9 September 2025
What FDA wrote in the same batch of letters (9 Sep 2025): “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.”
Example of wording that drops the claim: Compounded options can cost less than brand-name medicines. They are not FDA-approved and are not interchangeable with them.
“FDA-Approved Medication”FDA warning letter, 9 September 2025
“FDA Approved”FDA warning letter, 9 September 2025
“FDA-Approved Active”FDA warning letter, 9 September 2025
What FDA wrote in the same batch of letters (9 Sep 2025): “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.”
Example of wording that drops the claim: Compounded drugs are not FDA-approved. Your clinician can explain how a compounded drug differs from an approved one.
“FDA approval: Semaglutide was approved by the U.S. Food and Drug Administration (FDA) in December 2017.”FDA warning letter, 9 September 2025
“FDA approval: Tirzepatide was approved by the U.S. Food and Drug Administration (FDA) in 2022.”FDA warning letter, 9 September 2025
“Compounded semaglutide was first introduced and patented in 2016, and FDA approved as a type 2 diabetes treatment in 2017. It wasn’t until 2021 that compounded semaglutide was approved as a treatment for obesity!”FDA warning letter, 9 September 2025
What FDA wrote in the same batch of letters (9 Sep 2025): “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.”
Example of wording that drops the claim: Semaglutide is the active ingredient in some FDA-approved medicines. The compounded product we prescribe is not one of them and has not been reviewed by FDA.
“FDA-licensed Facilities.”FDA warning letter, 8 June 2026
“FDA-licensed 503(a) outsourcing facilities.”FDA warning letter, 8 June 2026
“FDA-approved pharmacy.”FDA warning letter, 8 June 2026
What FDA wrote in the same batch of letters (8 Jun 2026): “Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities.”
Example of wording that drops the claim: Filled by a state-licensed pharmacy. (For a registered outsourcing facility: an outsourcing facility registered with FDA under section 503B. Registration is not FDA approval.)
“Compounding semaglutide involves creating small, customized batches of the medication in an FDA-monitored, state-licensed pharmacy, using FDA-approved ingredients….”FDA warning letter, 9 September 2025
“Compounding tirzepatide involves creating small, customized batches of the medication in an FDA-monitored, state-licensed pharmacy, using FDA-approved ingredients….”FDA warning letter, 9 September 2025
“Compounded Generic Semaglutide is a revolutionary FDA-inspected medication for rapid weight loss that is given once weekly.”FDA warning letter, 9 September 2025
What FDA wrote in the same batch of letters (9 Sep 2025): “Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not.”
Example of wording that drops the claim: Filled by a state-licensed pharmacy that follows USP compounding standards. (State only what is documented.)
“Proven to lose weight effectively”FDA warning letter, 8 June 2026
What FDA wrote in the same batch of letters (8 Jun 2026): “Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.”
Example of wording that drops the claim: Many patients lose weight on GLP-1 treatment with diet and activity. Results vary and are not guaranteed.
“Clinically shown to support 15-22% average body weight reduction.”FDA warning letter, 9 September 2025
What FDA wrote in the same batch of letters (9 Sep 2025): “Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.”
Example of the change: Remove the figure. If a figure stays, state the study, the drug studied, the population and that it was not a compounded product.
The safer wording comes from our draft telehealth rules, which are open for comment and not yet in force: read the draft rules. It is an example of wording that drops the claim, not a promise about what FDA or a platform will accept.
“This is a compounded drug. Compounded drugs are not FDA-approved and FDA does not review them for safety, effectiveness or quality. A licensed clinician decides whether it is right for you.”
Based on FDA’s page on unapproved GLP-1 drugs used for weight loss. It does not make a brand comparison safe to keep.
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