Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1the representations on your website that WeightCare is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.1(h)(2)
- 21 CFR 201.1(a)