HydraMed IV LLC dba HydraMed
2 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
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.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The website labels falsely suggest HydraMed is the manufacturer of the compounded drugs, which is misleading under FDA regulations.
Supporting FDA text
Source excerpt · automated text-match checkThe 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.
The website falsely claims the products come from an FDA-approved pharmacy, implying FDA approval that does not exist for compounding facilities.
Supporting FDA text
Source excerpt · automated text-match checkYour 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.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Identify the entities that produce the compounded drug products offered on your website
- Provide a representative sample of labeling for such drug products
- Address other website claims that contain false or misleading representations about your compounded drug products or demonstrate that such claims have been modified or removed
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.