CRITICALPharmacy / CompoundingFDA Warning Letter · June 8, 2026

Public Health Solution LLC dba DrMedHealth

Atlas ID: 2026-06-fda-public-health-solution-llc-dba-drmedheal-uzxd9i

FDA issued a warning letter to Public Health Solution LLC dba DrMedHealth (Fredericksburg, VA) in June 2026 after reviewing their website and finding false or misleading claims about compounded semaglutide and tirzepatide products. The company's website stated these compounded products contained the 'Same active ingredient as Ozempic®' and 'Same active ingredient as Mounjaro®,' which FDA determined falsely implied FDA approval or evaluation for safety and effectiveness. These representations caused the products to be misbranded under FD&C Act sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 business days and warned that failure to comply could result in seizure or injunction.

Flagged claims (2)

Same active ingredient as Ozempic®

FDA trademark misuse · implied-fda-approval-via-brand-comparison

Same active ingredient as Mounjaro®

FDA trademark misuse · implied-fda-approval-via-brand-comparison

Required actions (2)

Send your written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance at [email protected] within fifteen (15) business days of receipt of this letter.

Response required · 15 days

Addressing other website claims that contain false or misleading representations about your compounded drug products or demonstrating that such claims have been modified or removed in light of FD&C Act §§ 502(a) and 502(bb) [21 U.S.C. §§ 352(a) and 352(bb)].

Claim removal

Source

www.fda.gov · FDA Warning Letter

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