Rule CG-REG-006
Regulatory status: what rule CG-REG-006 checks
Rule CG-REG-006 is one of the checker's regulatory status rules. It cites FDCA 503A. The reason, source and safer wording are below.
CG-REG-006 · Blocks approval · Citation checked against stored text
Compounded drugs are not FDA approved and are not the same as, or generics of, the brand product. Telehealth sellers have received FDA warning letters for these claims.
Source: FDCA 503A and 503B; FDA warning letters to telehealth firms on compounded GLP-1 marketing; FTC Act section 5
Safer wording: Say the medication is compounded, that it is not FDA approved, and that a licensed clinician decides whether it is appropriate.
FDCA 503A · Needs counsel review
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