Amazing Meds

Selected passages from the FDA letter

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

Passage 1

your claim concerning compounded semaglutide products is false or misleading under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)]

Passage 2

your compounded retatrutide drug products are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for its intended use. Consequently, their labeling fails to bear adequate directions for their intended use causing them to be misbranded under section 502(f)(1) of the FDCA

Passage 3

your compounded retatrutide drug products are unapproved new drugs and misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a), 502(f)(1), 301(a) and 301(d) of the FDCA