GLP-1 Solution: What the FDA Letter Means for What You Pay

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://glp1solution.store in August 2025 and has observed that your website offers various compounded drug products, including retatrutide, semaglutide and tirzepatide.

1. 1

   “Drug products compounded using retatrutide are not eligible for the exemptions provided by section 503A, because retatrutide is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug, and does not appear on the 503A bulks list.”

2. 2

   “There are no FDA-approved applications on file for your compounded retatrutide drug products.”

3. 3

   ““Semaglutide is the generic drug delivered in Ozempic (injectable) and Rybelsus (oral) diabetes control medications, and Wegovy (injectable) weight loss medication.””

4. 4

   “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.”

1. 1

   Letter issued

   September 2025

2. 2

   15-working-day response window

   FDA gives the company 15 working days to respond in writing.

3. 3

   Close-out, if issued

   FDA may post one once it is satisfied the cited issues have been corrected.

The site FDA reviewed no longer trades. In August 2026 glp1solution.store returned an HTTP 301 redirect to a domain-marketplace listing offering the name for sale, with no storefront behind it, and glp1solution.com refused the connection. We found no replacement site under a comparable name. This is evidence the storefront has stopped, not a confirmed corporate dissolution.

Treat this page differently from the rest of the roster. Most of these letters are arguments about adjectives; this one includes an argument about whether a product could lawfully be compounded at all. Retatrutide is an investigational molecule with no approved product anywhere, and FDA's position is that because it sits on neither the 503A nor the 503B bulks list, the usual compounding exemptions simply do not reach it. The word to notice in the marketing half is "generic" — a category that exists for copies of approved drugs that have passed an FDA review. A compounded GLP-1 is not one, so the word imports a guarantee that was never issued, and it does it in the exact place a shopper is comparing prices. The practical point stands even though the storefront is gone: a price for a compound that no approved product corresponds to is not a discount on anything, because there is nothing to discount it from.

As of August 2026, FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence GLP-1 Solution failed to respond.