Farmakeio Outsourcing LLC

Selected passages from the FDA letter

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

Passage 1

We remind you that for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information, including “the statement ‘This is a compounded drug.’ or a reasonable comparable alternative statement (as specified by the Secretary) that prominently identifies the drug as a compounded drug” (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]).] FDA acknowledges your statement that “FarmaKeio Outsourcing LLC will…add the phrase ‘This is a’ to our product labels in front of the statement ‘Compounded Drug’ which already exists on our product labels.”