Reading the offer · 8 company examples
FDA Letters About Pharmacy Approval Claims
A pharmacy credential is not drug approval
A seller can describe the pharmacy behind a prescription accurately and still leave an important question unanswered: has FDA approved the finished medication? These letters address a different problem: pharmacy descriptions using an FDA approval or licensing designation that the agency says it does not grant.
For someone comparing prices, a claimed pharmacy credential can make a lower quote appear to come with the same regulatory review as a branded medicine. It does not establish that. Read the exact credential, identify the dispensing pharmacy and distinguish a facility registration from approval of a product.
Some letters below also address vial labels or drug comparisons. Those additional concerns remain in the company sections; grouping a letter here does not reduce it to a single allegation.
An FDA warning letter is a public regulatory communication stating the agency's view. It is not a recall, a fine, a criminal charge, an injunction, or a finding that a company has broken the law.
This guide was organized in October 2026. Each company’s source-check date below is kept separately; the guide date does not mean its letter status was checked again.
Altru Telehealth
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
FDA listed two violations and quoted no label finding at all. The first collects three claims, one of which reaches past the active ingredient to the price: "Compounded semaglutide & tirzepatide offers the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & Wegovy." The others describe the compound as combining "the FDA approved active ingredient semaglutide with a body safe vitamin such as B12" and as "the active ingredient used in FDA-Approved weekly injection Wegovy® and Mounjaro". The second violation is about the supply chain rather than the drug: the site said "[a]n FDA approved, regulated & sterile compounding pharmacy mixes the formula" and "[o]ur compounding pharmacies are all FDA approved", and FDA answered that no such designation exists for pharmacies or outsourcing facilities.
What it means for the offer
Most of these letters argue about a sentence describing a drug. This one quotes a sentence describing a bargain — the same results at a fraction of the cost — and that is a different kind of claim to weigh, because it is the one a price comparison actually rests on. "Same active ingredient" is a chemistry statement you can check. "Same results" is a claim about outcomes in people, and compounded versions have not been through the trials that would establish it, which is precisely FDA's point. The savings may still be real; what the letter disputes is the promise that nothing is given up in exchange for them. The second finding matters for a related reason. Told that a pharmacy is "FDA approved, regulated & sterile", a reader reasonably stops asking who mixes the drug. FDA's response is that there is no such approval to have. Neither finding says the medication is unsafe, and neither says the price is wrong — they say the two reassurances offered alongside that price were not the agency's to give.
Quoted passages and recorded context
Violations were identified and documented during a review of Altru Telehealth’s website, [Altru Telehealth's website], FDA Establishment Identifier (FEI) 3044020130, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products. As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.
1. The following claims concerning compounded semaglutide and tirzepatide products appear on your website: “Compounded semaglutide combines the FDA approved active ingredient semaglutide with a body safe vitamin such as B12.” “Compounded semaglutide & tirzepatide offers the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & Wegovy.” “Semaglutide & Tirzepatide is the active ingredient used in FDA-Approved weekly injection Wegovy® and Mounjaro….“ 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.
2. Your website claims ”[a]n FDA approved, regulated & sterile compounding pharmacy mixes the formula based on the medical providers [sic] prescription” and “[o]ur compounding pharmacies are all FDA approved....” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an "FDA-approved" or "FDA-licensed” designation for pharmacies or outsourcing facilities. Therefore, representing a compounding pharmacy or outsourcing facility as “FDA-approved” or “FDA-licensed” is false and misleading, as these terms imply a formal authorization that FDA does not grant to such entities or their compounded products.
Altru Telehealth's website was live in August 2026, titled "Online Urgent Care in 2 Hours | Altru Telehealth" and selling urgent-care visits from $36.99. The compounded weight-loss line the letter concerns was not visible: the homepage contained no mention of "semaglutide", "tirzepatide" or "GLP-1", and its weight-loss page no longer exists. The company is plainly operating; what is not visible is the product the letter is about.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Clover Meds
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
FDA listed two numbered violations and quoted no brand-comparison copy. The first is the private-label finding: the compounded products shown on the site "identify “Clover Meds” on the pictured label, suggesting Clover Meds is the compounder of those drugs when in fact it is not." The second is about the supplier the site described rather than the product — the page said its compounded drug products are sourced from "FDA-licensed Facilities", and FDA answered that "Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities." Its footnote adds the part that matters most: a firm may register with FDA as a 503B outsourcing facility, but "this registration does not constitute FDA approval or licensure of the facility or its compounded drug products."
What it means for the offer
There is a specific reason this phrasing is worth pausing on. "FDA-licensed Facilities" is plural and anonymous — it does not name a pharmacy you could go and check, it gestures at a category and asks you to accept that the category has been vetted. FDA's footnote here is the clearest statement of why that fails anywhere in this dataset: a compounder can register with FDA as a 503B outsourcing facility, and registration is not approval or licensure of the facility or of anything it makes. Neither 503A compounders nor 503B outsourcing facilities go through premarket review. So the reassurance was doing two jobs — telling you the supply chain is supervised, and letting the supplier stay unnamed — and the letter removes the first without filling in the second. That is a gap in what you know about who fills your order, not a statement about the drug in the vial. Combined with the label finding, the honest read is simply that this page did not, at the time FDA looked, let you identify who compounded what you were paying for.
Quoted passages and recorded context
Violations were identified and documented during a review of Clover Meds’ website, [Clover Meds' website], FDA Establishment Identifier (FEI) 3044175705, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.
1. The compounded semaglutide and tirzepatide products displayed on your website identify “Clover Meds” on the pictured label, suggesting Clover Meds is the compounder of those drugs when in fact it is not.
2. Your website claims that the compounded drug products it offers are sourced from “FDA-licensed Facilities.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an "FDA-approved" or "FDA-licensed” designation for pharmacies or outsourcing facilities.
While an entity may elect to register with FDA as an outsourcing facility under section 503B of the FD&C Act [21 U.S.C. § 353b], this registration does not constitute FDA approval or licensure of the facility or its compounded drug products. Neither compounders operating under section 503A nor outsourcing facilities operating under section 503B undergo FDA premarket review or approval of their compounded drug products.
Clover Meds' website returned a live site on 2026-08-09 titled "Virtual Weight Loss Clinic - Clover Meds™", carrying a new-patient promotion ("New patients use code SUMMER2026 for 10% OFF") and product routes for compounded semaglutide, compounded tirzepatide, testosterone therapy and NAD+; no price is posted on the landing page itself.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Harper Meds
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
The third violation is the one that does not appear in the earlier waves: the site said its products were sourced from "FDA-licensed 503A Outsourcing Facilities," and FDA replied that "compounding facilities, including pharmacies and outsourcing facilities, are not 'FDA-approved' or 'FDA-licensed' entities. The FD&C Act does not establish an 'FDA-approved' or 'FDA-licensed' designation for pharmacies or outsourcing facilities." FDA also cited "Same active ingredient as Ozempic™ & Wegovy™" and noted the pictured label identifies "Harper Meds" as the compounder when it is not.
What it means for the offer
By June 2026 FDA had started going after a different sentence, and this letter is the clearest example of it. The earlier waves were about what sellers said the medicine was; this one is about what they said the pharmacy was. "FDA-licensed" sounds like a credential you could look up, and it is not one — there is no such designation for a compounding pharmacy or an outsourcing facility. Registering as a 503B outsourcing facility does put a firm on an FDA list and subject it to inspection, but FDA's own footnote spells out that registration "does not constitute FDA approval or licensure," and that neither 503A nor 503B compounders undergo premarket review. The cited phrase also blends the two: 503A describes traditional compounders, while outsourcing facilities register under 503B. For price comparison this matters because supplier language is often the only quality signal a cheap listing offers. Treat it as a description of a business model, not a certification.
Quoted passages and recorded context
Violations were identified and documented during a review of Harper Meds’ website, [Harper Meds' website], FDA Establishment Identifier (FEI) 3044020867, in March 2026.
Your website claims that the compounded drug products it offers are sourced from “FDA-licensed 503A Outsourcing Facilities.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an “FDA-approved” or “FDA-licensed” designation for pharmacies or outsourcing facilities.
Therefore, representing a compounding pharmacy or outsourcing facility as “FDA-approved” or “FDA-licensed” is false and misleading, as these terms imply a formal authorization that FDA does not grant to such entities or their compounded products.
While an entity may elect to register with FDA as an outsourcing facility under section 503B of the FD&C Act [21 U.S.C. § 353b], this registration does not constitute FDA approval or licensure of the facility or its compounded drug products. Neither compounders operating under section 503A nor outsourcing facilities operating under section 503B undergo FDA premarket review or approval of their compounded drug products.
Harper Meds' website returned a live storefront when we checked in August 2026, running a five-minute eligibility quiz and showing semaglutide and tirzepatide as in stock, with customer testimonials on the homepage. We did not review every page on the site.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
HydraMed
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
FDA listed two violations and quoted no marketing claim about the medication itself. The first is the label: the products "identify “HydraMed” on the pictured label, suggesting HydraMed is the compounder of those drugs when in fact it is not." The second is the credential: the site said its compounded products are sourced from an "FDA-approved pharmacy", and FDA answered that compounding facilities "are not “FDA-approved” or “FDA-licensed” entities" and that representing one as such "is false and misleading, as these terms imply a formal authorization that FDA does not grant".
What it means for the offer
Strip out the sales copy and this letter is entirely about provenance: who made the drug, and who is supposed to have vouched for them. Both answers on the page were wrong in the same direction. The vial carried the seller's name rather than the compounder's, and the compounder was described as an "FDA-approved pharmacy" — a status FDA says does not exist for any pharmacy or outsourcing facility, because none of them undergo premarket review. Those two claims work together on a reader. One suggests the company you are buying from made the medicine; the other suggests a regulator signed off on whoever did. Together they close the question of sourcing entirely, which is the question worth keeping open when the same molecule is sold at very different prices by very different operators. The separate practical point is that when we checked, the site would not load at all. That is not evidence the business has closed and we have not recorded it as such — but it is a reason to confirm a seller can actually take and fulfill an order before paying one.
Quoted passages and recorded context
Violations were identified and documented during a review of HydraMed’s website, [HydraMed's website], FDA Establishment Identifier (FEI) 3044021141, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products. As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.
1. The compounded semaglutide and tirzepatide products displayed on your website identify “HydraMed” on the pictured label, suggesting HydraMed is the compounder of those drugs when in fact it is not.
2. Your website claims that the compounded drug products it offers are sourced from an “FDA-approved pharmacy.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an “FDA-approved” or “FDA-licensed” designation for pharmacies or outsourcing facilities. Therefore, representing a compounding pharmacy or outsourcing facility as “FDA-approved” or “FDA-licensed” is false and misleading, as these terms imply a formal authorization that FDA does not grant to such entities or their compounded products.
HydraMed's website was down in August 2026, showing only its own error page: "500 Something went wrong! While we fix the server, please reach out to us", above two staffed contact numbers. Its weight-loss and shop pages were also missing. A site that is temporarily broken is not evidence of closure — the error page itself invites contact — so this is recorded as unknown rather than ceased.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Medica Weight Loss
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
FDA listed three violations. The label finding turns on a lower-case wording: the products "identify “medica weight loss” on the pictured label, suggesting Medica Weight Loss is the compounder of those drugs when in fact it is not." The claim finding quotes two lines that state approval outright rather than implying it — "Clinical studies and FDA approval support [semaglutide’s] safety and effectiveness…." and "Tirzepatide is FDA-approved…." — with FDA answering that "Compounded drug products are not FDA-approved." The third concerns the supplier: the site said its compounded products are sourced from an "FDA-approved pharmacy", and FDA replied that the FD&C Act establishes no such designation for pharmacies or outsourcing facilities.
What it means for the offer
There is a real difference between a page that invites you to infer approval and a page that simply asserts it, and this one asserts it: "Tirzepatide is FDA-approved...." That sentence is true of Mounjaro and Zepbound, the branded products. It is not true of the compounded tirzepatide being sold beside it, and the letter's reply is one line with nothing left to interpret. The same goes for "Clinical studies and FDA approval support safety and effectiveness" — the studies exist, but they were run on the approved product. Borrowing their conclusion for a different, unapproved one is the move FDA objected to. That matters when a price is on the screen, because approval is the shortcut most people use to stop evaluating and start buying. The label finding is worth a second look as well: the vial read the company's name in lower case, and FDA still counted it as a claim to have compounded the drug. Typography does not create distance. None of this concerns whether the medicine is safe or whether $197 is a fair price — it concerns whether the strongest sentence on the page was one the company was entitled to write.
Quoted passages and recorded context
Violations were identified and documented during a review of Medica Weight Loss’ website, [Medica Weight Loss' website], FDA Establishment Identifier (FEI) 3044019522, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products. As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.
1. The compounded semaglutide and tirzepatide products displayed on your website identify “medica weight loss” on the pictured label, suggesting Medica Weight Loss is the compounder of those drugs when in fact it is not.
2. The following claims concerning compounded semaglutide and tirzepatide products appear on your website: “Clinical studies and FDA approval support [semaglutide’s] safety and effectiveness….” “Tirzepatide is FDA-approved….” 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.
3. Your website claims that the compounded drug products it offers are sourced from an “FDA-approved pharmacy.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an “FDA-approved” or “FDA-licensed” designation for pharmacies or outsourcing facilities. Therefore, representing a compounding pharmacy or outsourcing facility as “FDA-approved” or “FDA-licensed” is false and misleading, as these terms imply a formal authorization that FDA does not grant to such entities or their compounded products.
Medica Weight Loss' website returned a live site on 2026-08-09 titled "Semaglutide & Tirzepatide Weight Loss Injections | Medical", advertising "Plans starting at $197" with an eligibility check and a working account login — an operating storefront.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Momentum Health
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
FDA listed three numbered violations. The first is the private-label finding, extended here to liraglutide as well as semaglutide and tirzepatide: the pictured products "identify “Momentum Health” on the pictured label, suggesting Momentum Health is the compounder of those drugs when in fact it is not." The second quotes brand-equivalence copy including "Our platform provides seamless access to advanced GLP-1 medications, such as compounded Semaglutide (found in Ozempic® and Wegovy®) and Tirzepatide (found in Mounjaro® and Zepbound™)…". The third addresses the pharmacy rather than the product: the site described a "meticulously formulated [sic] FDA-licensed compounding facility", and FDA answered that no such designation exists.
What it means for the offer
This letter is worth reading because it puts all three of this market's misleading patterns on one page, and they work at different distances from the product. The label finding is about who made it. The equivalence claims are about what it is. The "FDA-licensed compounding facility" line is about who is vouching for it — and that last one is the reassurance most likely to make you accept a price without asking further, because it sounds like a regulator has been through the door. FDA's answer is unusually flat: there is no FDA-approved or FDA-licensed designation for compounding pharmacies or outsourcing facilities, so the phrase describes an authorization that does not exist. None of this says the medicine is unsafe. It says the three things a page offered you as grounds for confidence — the maker, the equivalence and the credential — are each softer than they were written to sound.
Quoted passages and recorded context
Violations were identified and documented during a review of Momentum Health's website […], FDA Establishment Identifier (FEI) 3043997131, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide, tirzepatide, and liraglutide products.
1. The compounded semaglutide, tirzepatide, and liraglutide products displayed on your website identify “Momentum Health” on the pictured label, suggesting Momentum Health is the compounder of those drugs when in fact it is not.
2. The following claims concerning compounded semaglutide and tirzepatide products appear on your website: “Same active ingredient in Mounjaro® and Zepbound™…” “Same active ingredient in Wegovy® and Ozempic®…” “Our platform provides seamless access to advanced GLP-1 medications, such as compounded Semaglutide (found in Ozempic® and Wegovy®) and Tirzepatide (found in Mounjaro® and Zepbound™)…”
3. Your website claims “Compounded Semaglutide refers to a medication meticulously formulated [sic] FDA-licensed compounding facility….” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an "FDA-approved" or "FDA-licensed” designation for pharmacies or outsourcing facilities.
Momentum Health's website was live in August 2026 with a working shop: it lists compounded semaglutide, tirzepatide and liraglutide among other products, and the compounded semaglutide page had a working add-to-cart button, which points to an operating storefront rather than a closed one.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
NOVARX
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
FDA listed three violations, each narrower than it first appears. The label finding turns on a spelling: the products "identify “NOVA RX” on the pictured label, suggesting NOVARX is the compounder of those drugs when in fact it is not." The claim finding covers semaglutide only and quotes a single line naming one brand — "…access to the same active ingredient found in Ozempic." — with FDA responding that "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 third concerns the supplier: the site said its products come from "FDA Approved Pharmacies", and FDA answered that no such designation exists for pharmacies or outsourcing facilities.
What it means for the offer
Two of these findings are small enough to be easy to miss and are worth naming anyway. The label read "NOVA RX" while the company is NOVARX, and FDA still treated it as a representation that NOVARX compounded the drug — so a space in the middle of a word does not create distance between a brand and a product it did not make. And the credential claim said "FDA Approved Pharmacies", not the "FDA-licensed" phrasing most of this market uses. Approved is the stronger word and the more wrong one: FDA does not approve or license compounding pharmacies at all, so the more confident version of the claim is no more true than the cautious one. The part that bears on a purchase is separate from all of that. When we checked, the site FDA reviewed was serving a maintenance page and the domain on the company's own contact address had become something else entirely. That is not evidence the business has closed, and we have not recorded it as such. It is a reason to confirm a seller is actually there before sending money — which is ordinary caution, and not something the warning letter itself says.
Quoted passages and recorded context
Violations were identified and documented during a review of NOVARX’s website, [NOVARX's website], FDA Establishment Identifier (FEI) 3044022416, in March 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products.
1. The compounded semaglutide and tirzepatide products displayed on your website identify “NOVA RX” on the pictured label, suggesting NOVARX is the compounder of those drugs when in fact it is not.
2. The following claims concerning compounded semaglutide products appear on your website: “…access to the same active ingredient found in Ozempic.” 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.
3. Your website claims that the compounded drug products it offers are sourced from “FDA Approved Pharmacies.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities.
NOVARX's website, the one FDA reviewed, was down for maintenance in August 2026, showing only a holding page: "Maintenance Mode. We're working a few things. We'll be back in some hours." Separately, the web address in the letter's contact email now leads to an unrelated third-party site titled "Togel Singapore: Keluaran SGP" with no NOVARX content. Neither is proof of closure — a holding page can come before a relaunch, and anyone can buy up a lapsed web address — so this is recorded as unknown.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.
Ready Med
Read FDA’s letter →Letter issued · Status last checked · Active at that check
What FDA cited
FDA listed three violations. The label finding is the only one in this dataset naming two alternative strings: the products "identify “Ready Med” or “Ready Med Medical Weight Loss Center” on the pictured label, suggesting Ready Med is the compounder of those drugs when in fact it is not." The claim finding quotes "The same active ingredient in Mounjaro® and Zepbound™" and "The same active ingredient in Ozempic® and Rybelsus®" — the second reaching past the injections to the oral tablet — which FDA held "represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not." The third addresses sourcing: the site claimed an "FDA licensed compounding facility", a designation FDA says the FD&C Act does not establish.
What it means for the offer
The detail that repays attention is the pairing of Ozempic® with Rybelsus®. Those two are not interchangeable in the way the phrase "the same active ingredient" suggests: one is a weekly injection and the other a daily tablet, and the dose, the absorption and the approved use differ accordingly. A compounded injection cannot be equivalent to both, so a line claiming kinship with each is borrowing credibility from products that are not even equivalent to one another. FDA's own response goes further than the softer letters on this list — it says the claims represent approval rather than merely imply it. The label finding is the other unusual piece: the vials carried two different versions of the seller's name, and neither was the compounder's. Reading the two findings together, a buyer was told who made the drug (wrongly, in two forms) and what it was equivalent to (in a comparison that does not hold), which between them cover most of what a person would check before paying. The letter says nothing about whether the medication is safe or what it should cost.
Quoted passages and recorded context
Violations were identified and documented during a review of Ready Med’s website, [Ready Med's website], FDA Establishment Identifier (FEI) 3044868483, in May 2026. FDA observed that your website offers compounded drug products, including semaglutide and tirzepatide products. As described below, your website’s false or misleading claims concerning compounded semaglutide and tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor quality drug products.
1. The compounded semaglutide and tirzepatide products displayed on your website identify “Ready Med” or “Ready Med Medical Weight Loss Center” on the pictured label, suggesting Ready Med is the compounder of those drugs when in fact it is not.
2. The following claims concerning compounded semaglutide and tirzepatide products appear on your website: “The same active ingredient in Mounjaro® and Zepbound™” “The same active ingredient in Ozempic® and Rybelsus®” 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.
Ready Med's website returned a live site on 2026-08-09 headed "Ready Med", printing the same Clearwater street address and Gmail contact address that appear on the FDA letter, and advertising a first-month weight-management offer with a $99 consultation and a booking flow — an operating clinic.
FDA response record checked : no company response was logged. That does not establish that the company did not respond.