The word is on the page because the brand drug earned it.
Semaglutide and tirzepatide, under their brand names, are FDA-approved drugs. A compounded version of either is not, and the FDA says so in one sentence on its own site. The trouble is that most compounded GLP-1 pages were written from the brand's approval outward. "Tirzepatide is FDA-approved." "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy". Sourced from an "FDA-approved pharmacy". Each of those lines read as true to the person who wrote it. Each is a claim that LegitScript's eighth standard reaches by name, and each is a sentence the FDA has quoted back to a telehealth company in a public warning letter.
What does Standard 8 say?
LegitScript publishes its nine Healthcare Certification standards on its own site. The eighth is titled Transparency, and it reads in full:
"The applicant and its affiliates must ensure that all practices and offers are accurate, transparent, and not misleading to patients or the public, including but not limited to any material detail regarding the pharmacy, pharmacy staff, medical practitioners, drugs, treatments, or financial transactions. This includes claims that a product or service has purported benefits that have not been supported by a regulatory body, such as the FTC, FDA, etc."
"Failure to provide full and accurate information as requested, as determined by LegitScript's sole discretion, will result in denial. Applicants may undertake reasonable remedial action during the certification process without penalty."
"An applicant's business practices may not pose a reputational risk to LegitScript or the LegitScript Healthcare Certification program."
The standard does not only ask that a page be accurate. It names the FDA as a body whose support a benefit claim needs, and the FDA's support is the one thing a compounded drug does not have. The second paragraph carries the consequence and the door in consecutive sentences: denial, and remedial action during the process "without penalty".
The application checklist repeats the point under Patient Services: "Please ensure advertising claims are in line with current guidelines. For US merchants, this includes guidelines from the FDA and FTC." The next item asks: "Does your platform facilitate the sale of compounded medications? If so, please complete each applicable tab within our compounding addendum template." Compounded drugs are inside the program, and what a pharmacy may compound is the subject of our 503A and 503B explainer. The claim about them is what fails. The certification terms make it a warranty: "Applicant represents and warrants that all information provided to the public on its website or websites is and will be truthful, accurate, and not misleading."
LegitScript has also named this exact sentence. Its GLP-1 page from July 2024 lists what it considers violative content, and the fourth item is "Compounding pharmacies claiming that their GLP-1 drugs are FDA-approved". Its press release from the same month adds that "There are also no FDA-approved generic versions of these products."
What does the FDA say the word means?
The FDA's compounding questions and answers page asks "Are compounded drugs approved by FDA?" and answers: "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed." The next question, whether compounded drugs and generic drugs are the same, gets "No", because a generic is approved under section 505(j) of the Federal Food, Drug, and Cosmetic Act and a compounded drug is not approved at all.
The FDA's GLP-1 page, current as of 1 October 2026, lists telehealth red flags for consumers, and the first is a company that "makes claims such as the compounded drug is the same as an FDA-approved drug".
The pharmacy gets the same treatment. Warning letters the FDA issued in June 2026 say that compounding facilities, "including pharmacies and outsourcing facilities", are not FDA-approved or FDA-licensed entities, because the FD&C Act "does not establish" any such "designation for pharmacies or outsourcing facilities". The two terms "imply a formal authorization that FDA does not grant to such entities or their compounded products". On the 503B question specifically: "this registration does not constitute FDA approval or licensure of the facility or its compounded drug products."
Which sentences has the FDA already written letters about?
The FDA has been quoting GLP-1 landing pages back to their owners for over a year, and the letters are public.
September 2025. The FDA launched its crackdown on misleading direct-to-consumer drug advertising and sent telehealth firms the first group of warning letters about compounded GLP-1 claims. One dated 9 September 2025 quotes two lines from the company's site, "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy" and "Clinically proven ingredients", and concludes: "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."
6 February 2026. The Commissioner's statement set out what a page cannot say: "In promotional materials, companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA. They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient." Four claims, and most GLP-1 pages make at least two of them.
3 March 2026. The FDA announced 30 warning letters to telehealth companies "for making false or misleading claims regarding compounded GLP-1 products offered on their websites", the second group since the September crackdown. The announcement names the primary violations: "making claims implying sameness with FDA-approved products and obscuring product sourcing by advertising drug products branded with the telehealth firm's name or trademark without qualification, implying they are the compounder."
8 June 2026. Letters dated that day, following website reviews in March 2026, quote the sentences this post opened with. One site said "Tirzepatide is FDA-approved" and that its products were sourced from an "FDA-approved pharmacy". Another said "Compounded semaglutide combines the FDA approved active ingredient semaglutide with a body safe vitamin such as B12" and that "[o]ur compounding pharmacies are all FDA approved". The FDA's answer to the drug claims is the same two sentences in both letters: "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."
One line in those letters matters more than the rest for a copywriter. The June letter that said its compounding pharmacies were all FDA approved also lists "Semaglutide & Tirzepatide is the active ingredient used in FDA-Approved weekly injection Wegovy® and Mounjaro" among the claims about the compounded products. That sentence is true about the brand drugs. The FDA listed it among the claims about the compounded products anyway. Where a sentence lives decides what it claims.
The letters also pick up the label. One cites product images with the telehealth company's own name on the pictured vial, "suggesting" the company "is the compounder of those drugs when in fact it is not". Your logo on the vial is a sourcing claim.
Why does the letter come to you and not the pharmacy?
Because the letters are about the website. Each June letter opens with the violations "identified and documented during a review of" the company's website and the observation that "your website offers compounded drug products". The legal basis is section 502(bb) of the Federal Food, Drug, and Cosmetic Act, under which "a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular". The letters give fifteen business days to respond, and the first step they list for that response is identifying "the entities that produce the compounded drug products offered on your website". That is a disclosure LegitScript already requires twice: Standard 4 makes you disclose every affiliate and partner pharmacy to LegitScript, and the terms make the dispensing pharmacy's address, telephone and fax number reachable from the page where a patient can find them. Our partner pharmacy post covers both. A page that hides the compounder behind the telehealth brand fails both reviews for one reason.
What can the page say instead?
The fix is a set of replacements, not a disclaimer at the bottom. A footnote saying compounded drugs are not FDA approved under a headline saying they are is still the headline.
- FDA-approved semaglutide. Write compounded semaglutide, and put the FDA's own sentence next to it: compounded drugs are not FDA approved.
- Same active ingredient as Ozempic. Generic Wegovy. Clinically proven. Cut all three. They are the claims the FDA's February 2026 statement says companies cannot make, and LegitScript's own page says there are no FDA-approved generic versions.
- FDA-approved pharmacy. FDA-approved 503B facility. Write the pharmacy's status the way its own license reads: a state-licensed pharmacy, or an outsourcing facility registered with FDA under section 503B. Registered, inspected and licensed are different words with different owners, and none of them is approved.
- A true sentence about the brand drug on the compounded product's page. Move it or cut it. The June letter shows the FDA reads it as a claim about what you are selling.
- Your brand on the vial. Either the compounder's name is on the label image, or there is no label image. "Without qualification" is the phrase in the letter.
- The pharmacy, unnamed. Name it, with the address, telephone and fax number LegitScript's terms require.
What is left is shorter and more honest: what the drug is, that it is compounded and not FDA approved, who compounds it, that a licensed provider decides whether to prescribe it, and how to start the visit. That is also the page our Standard 7 post describes, where the medication page is an information page and the button starts the eligibility check rather than a cart.
Do it before you submit. Standard 8 says remedial action during the process is without penalty, and an FDA letter gives fifteen business days. The first is the cheaper deadline.
LegitScript decides certification in its own discretion, the FDA decides what is misbranded, and nothing here predicts either decision on your business; this is website and copy guidance, not legal, regulatory or medical advice. ToolBX Media is a LegitScript partner, and a search of every page, email and ad for "FDA", "approved", "generic", "same as", "clinically proven" and each brand name is the first pass we run on a compounded GLP-1 site before a submission. Score your own site with the LegitScript readiness score, work through the web developer's checklist, or have us read the storefront and the application together in a telehealth program fit review.
Common questions
Can I say FDA-approved on a page that sells compounded semaglutide?
No. The FDA's own compounding page says compounded drugs are not FDA-approved and that the agency does not verify their safety, effectiveness or quality before they are marketed. LegitScript's Standard 8 requires every offer to be accurate and not misleading, including claims that a product has benefits not supported by a regulatory body such as the FDA, and LegitScript's GLP-1 page lists compounding pharmacies claiming their GLP-1 drugs are FDA-approved as violative content. The FDA has quoted that kind of claim, such as Tirzepatide is FDA-approved, back to telehealth companies in warning letters dated as recently as June 2026. Semaglutide under its brand names is an FDA-approved drug. A compounded version of it is not, and the page is selling the compounded version.
Is a 503B outsourcing facility FDA approved?
No. In warning letters issued in June 2026 the FDA wrote that compounding facilities, including pharmacies and outsourcing facilities, are not FDA-approved or FDA-licensed entities, and that the Federal Food, Drug, and Cosmetic Act does not establish an FDA-approved or FDA-licensed designation for pharmacies or outsourcing facilities. A 503B facility registers with FDA, and the same letters say that registration does not constitute FDA approval or licensure of the facility or its compounded drug products. The accurate phrase is outsourcing facility registered with FDA under section 503B, or state-licensed pharmacy for a 503A pharmacy. Registered is not approved.
Can I say compounded semaglutide has the same active ingredient as Ozempic or Wegovy?
The FDA's February 2026 statement says companies cannot claim in promotional materials that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA, cannot state that compounded drugs use the same active ingredient as the FDA-approved drugs, and cannot state that compounded drugs are clinically proven to produce results. A September 2025 warning letter quoted the line weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy and said the claim implied the product was the same as an FDA-approved product. A June 2026 letter listed a sentence that was true about the brand drugs among the claims about the compounded products anyway.
Does LegitScript actually read website copy about compounded drugs?
Its standards and checklist say it does. Standard 8 covers any material detail regarding drugs and treatments and names the FDA and FTC as the regulatory bodies whose support a benefit claim needs. The application checklist tells US applicants to ensure advertising claims are in line with guidelines from the FDA and FTC, and asks any platform that facilitates the sale of compounded medications to complete a compounding addendum. The certification terms warrant that all information on the applicant's websites is truthful, accurate and not misleading. Standard 8 also says that failure to provide full and accurate information will result in denial, and that applicants may take reasonable remedial action during the certification process without penalty.
What has the FDA done about FDA-approved claims on compounded GLP-1 sites?
In September 2025 the FDA launched its crackdown on misleading direct-to-consumer drug advertising and sent telehealth firms the first group of warning letters about compounded GLP-1 claims. On 6 February 2026 the Commissioner's statement set out the claims companies cannot make. On 3 March 2026 the agency announced 30 warning letters to telehealth companies for false or misleading claims about compounded GLP-1 products on their websites, naming claims implying sameness with FDA-approved products and advertising drug products under the telehealth firm's own name without qualification among the primary violations. Letters dated 8 June 2026, following website reviews in March 2026, quote lines such as Tirzepatide is FDA-approved and sourced from an FDA-approved pharmacy. The letters cite sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act and give fifteen business days to respond.
My company does not make the drug. Why would the FDA write to me?
Because the letters are about the website. Each June 2026 letter says the violations were identified during a review of the company's website and that the website offers compounded drug products. The legal basis is section 502(bb) of the Federal Food, Drug, and Cosmetic Act, under which a compounded drug product is misbranded if its advertising or promotion is false or misleading in any particular, and section 502(a) on labeling. The FDA's compounding Q&A says prescription drug promotion disseminated by or on behalf of drug manufacturers, including compounders, must be truthful, non-misleading and accurate. The letters list identifying the entities that produce the compounded drugs offered on the site as the first step a response may include, which is the same pharmacy LegitScript's Standard 4 requires you to disclose and its terms require you to identify to patients.
Sources
- LegitScript, Healthcare Certification, the nine certification standards including Standard 8, Transparency checked 2026-11-04
- LegitScript, Healthcare Certification Application Checklist, document CHM-CE202-CHE-03, Patient Services and Affiliates sections checked 2026-11-04
- LegitScript, Healthcare Merchant Certification Terms and Conditions, Accuracy of Information checked 2026-11-04
- LegitScript, GLP-1 Sales Online, What You Need to Know, 17 July 2024, the list of violative content checked 2026-11-04
- LegitScript press release, LegitScript's Data Reveals 1200% Increase in Violative and Problematic Advertisements for GLP-1 Medications, Warning to Consumers checked 2026-11-04
- U.S. FDA, Compounding and the FDA, Questions and Answers checked 2026-11-04
- U.S. FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, content current as of 1 October 2026 checked 2026-11-04
- U.S. FDA, statement, FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs, 6 February 2026 checked 2026-11-04
- U.S. FDA, press announcement, FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s, 3 March 2026 checked 2026-11-04
- U.S. FDA, warning letter MARCS-CMS 716825, 9 September 2025 checked 2026-11-04
- U.S. FDA, warning letter MARCS-CMS 728274, 8 June 2026 checked 2026-11-04
- U.S. FDA, warning letter MARCS-CMS 728284, 8 June 2026 checked 2026-11-04
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