OrderlyMeds LLC dba OrderlyMeds
FDA issued a warning letter to OrderlyMeds LLC (dba OrderlyMeds) in Decatur, GA, citing misbranding violations related to compounded semaglutide and tirzepatide products marketed on its website. The agency found two specific false or misleading representations: (1) the company's logo appeared on product labels implying OrderlyMeds was the compounder when it was not, and (2) the website falsely described the compounding source as an 'FDA-licensed pharmacy,' a designation that does not legally exist. These representations rendered the products misbranded under FD&C Act sections 502(a) and 502(bb), and FDA warned that failure to correct violations could result in seizure or injunction.
Flagged claims (2)
FDA-licensed pharmacy
compounded drug products displayed on your website feature OrderlyMeds' logo on the pictured label, suggesting OrderlyMeds is the compounder of those drugs when in fact it is not
Required actions (4)
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.
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)].
Identifying the entities that produce the compounded drug products offered on your website;
Providing a representative sample of labeling for such drug products;
Does your site contain similar claims?
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