FDA warning letter · Drugs

Clover Meds LLC dba Clover Meds

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 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.

Passage 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.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.1(h)(2)
  • 21 CFR 201.1(a)