Rule CG-REG-007
Regulatory status: what rule CG-REG-007 checks
Rule CG-REG-007 is one of the checker's regulatory status rules. It cites FDCA 503A. The reason, source and safer wording are below.
CG-REG-007 · Blocks approval · Citation checked against stored text
FDA has sent warning letters to telehealth and online sellers over marketing of compounded GLP-1 drugs and unapproved peptides. Compounded drugs are not FDA approved, and these products raise misbranding and unapproved-drug issues.
Source: FDCA 503A and 503B; FDA warning letters to telehealth firms on compounded GLP-1 marketing
Safer wording: If you offer a compounded drug, say it is compounded and not FDA approved, that a licensed clinician decides if it is appropriate, and have counsel review the claims and the pharmacy relationship.
FDCA 503A · Needs counsel review
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