Sample report
FDA Letter Match: a sample report
This is a sample.It is built from lines FDA quoted in its telehealth warning letters, one for each kind of wording the check looks for. It is not a client’s report. No seller is named. It is unsigned.
Strong matches: 6
Wording FDA quoted again and again, such as a compounded drug tied to a brand name.
Strong matchSays a compounded drug has the same active ingredient as a brand
Match 1As FDA quoted it
“Same active ingredient as Ozempic®”
FDA telehealth warning letter, 8 Jun 2026 batch
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.”
What FDA said“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.”
The ruleA compounded drug must not be described as containing the same active ingredient as, or the same ingredient as, a named FDA-approved brand. Source: FD&C Act 502(bb), 21 U.S.C. 352(bb).
Strong matchTies a compounded drug to a brand ("found in", "the drug in")
Match 2As FDA quoted it
“Tadalafil (commonly known as Cialis) is a compound medication.”
FDA telehealth warning letter, 9 Sep 2025 batch
Wording that drops the claim
“Compounded tadalafil. Compounded drugs are not FDA-approved.”
What FDA said“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.”
The ruleThe brand name of an approved drug must not name, label or bracket a compounded product, in menus, cart lines, SKUs, page titles or ads. Source: FD&C Act 502(i)(3), 21 U.S.C. 352(i).
Strong matchCalls a compounded drug a generic or a version of a brand
Match 3As FDA quoted it
“Generic Zepbound, Mounjaro”
FDA telehealth warning letter, 20 Feb 2026 batch
Wording that drops the claim
“Compounded tirzepatide (not a generic and not FDA-approved).”
What FDA said“Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.”
The ruleA compounded drug must not be called a generic, a generic version, an equivalent or a compounded version of a brand-name drug. Source: FD&C Act 502(bb), 21 U.S.C. 352(bb).
Strong matchLikens a compounded drug to a brand
Match 4As FDA quoted it
“Tirzepatide (similar to Mounjaro) 10 mg vial”
FDA telehealth warning letter, 9 Sep 2025 batch
Wording that drops the claim
“Compounded tirzepatide, 10 mg vial. Compounded drugs are not FDA-approved.”
What FDA said“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.”
The ruleA compounded drug must not be likened to a brand by similarity, comparability, bioidentity or family resemblance. Source: FD&C Act 502(bb), 21 U.S.C. 352(bb).
Strong matchGives a pharmacy or facility an FDA status FDA does not grant
Match 5As FDA quoted it
“FDA-licensed pharmacy.”
FDA telehealth warning letter, 8 Jun 2026 batch
Wording that drops the claim
“Filled by a state-licensed pharmacy.”
Say this only if you hold the pharmacy’s state licence on file.
What FDA said“Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities.”
The ruleA compounding pharmacy or outsourcing facility must not be called FDA-approved, FDA-licensed or FDA-certified. Source: FDA telehealth warning letter, 8 Jun 2026 batch.
Strong matchOffers a drug FDA says cannot be compounded
Match 6As FDA quoted it
“Compounded Retatrutide [--] Active Ingredient in Mounjaro and Zepbound”
FDA telehealth warning letter, 9 Sep 2025 batch
No wording to offer
No rewording. The problem is the product and not the sentence: FDA says retatrutide cannot be used in compounding.
What FDA said“your compounded retatrutide drug products are unapproved new drugs and misbranded drugs”
The ruleThe site, ads and emails must not offer, describe dosing for, or link to an API that is not eligible for compounding under 503A or 503B. Source: FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.
Weaker matches: 4
Wording FDA also quoted, but which lawful pages use too. These are listed apart, and a person decides each one.
Weaker matchPuts "FDA-approved" beside a drug the site also sells compounded
Match 7As FDA quoted it
“All our treatments use FDA-approved active ingredients….”
FDA telehealth warning letter, 8 Jun 2026 batch
Wording that drops the claim
“Compounded drugs are not FDA-approved. Your clinician can explain how a compounded drug differs from an approved one.”
What FDA said“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.”
The ruleA compounded drug, its dosing schedule or its API must not be described as FDA-approved or FDA-cleared. Source: FD&C Act 502(bb), 21 U.S.C. 352(bb).
Weaker matchBorrows clinical proof ("clinically proven", "clinically studied")
Match 8As FDA quoted it
“clinically proven ingredients”
FDA telehealth warning letter, 20 Feb 2026 batch
Wording that drops the claim
“The active ingredient was studied in clinical trials of medicines FDA has approved. Our compounded product was not the product in those trials and is not FDA-approved.”
Name the ingredient. Say this only where FDA has approved the ingredient in another product.
What FDA said“Compounded drug products are not FDA-approved. Your claim implies that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.”
The ruleClinical-proof language must not be applied to a compounded drug, because the trials were run on the approved product, not on the compounded one. Source: FD&C Act 502(bb), 21 U.S.C. 352(bb).
Weaker matchUses "FDA-approved" or an FDA approval date on a page selling a compounded drug
Match 9As FDA quoted it
“FDA approval: Semaglutide was approved by the U.S. Food and Drug Administration (FDA) in December 2017.”
FDA telehealth warning letter, 9 Sep 2025 batch
Wording that drops the claim
“Semaglutide is the active ingredient in some medicines FDA has approved. The compounded semaglutide we prescribe is not FDA-approved, and FDA has not reviewed it.”
What FDA said“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.”
The ruleA compounded-drug page must not borrow the approval date, approved indication or prescribing information of a brand drug. Source: FD&C Act 502(bb), 21 U.S.C. 352(bb).
Weaker matchNames a brand beside the compounded drug
Match 10As FDA quoted it
“Ozempic (semaglutide) injection (4 weeks supply)”
FDA telehealth warning letter, 9 Sep 2025 batch
Wording that drops the claim
“Compounded semaglutide injection, 4 weeks supply.”
What FDA said“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.”
The ruleThe brand name of an approved drug must not name, label or bracket a compounded product, in menus, cart lines, SKUs, page titles or ads. Source: FD&C Act 502(i)(3), 21 U.S.C. 352(i).
In a client’s file, each match shows the sentence from your page, the page address, the closest line FDA quoted and a link to that letter.