Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your 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 [21 U.S.C. §§ 355(a), 352(f)(1), 331(a) and 331(d)].
Passage 2your claims concerning compounded retatrutide, semaglutide, and tirzepatide drug products are false or misleading under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.115