MedClub by Dr. Jenn

Selected passages from the FDA letter

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

Passage 1

There are no FDA-approved applications on file for your compounded retatrutide drug products. Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 355(a) and 331(d)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug.

Passage 2

Furthermore, 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 their intended use.

Passage 3

The following claims regarding compounded semaglutide products appear on your website: • “FDA Approved” • “USA Compounded” or “Custom Compounded” • “Generic Ozempic”