Rule CG-REG-052

Regulatory status: what rule CG-REG-052 checks

Rule CG-REG-052 is one of the checker's regulatory status rules. It cites 21 CFR 201.128. The reason, source and safer wording are below.

CG-REG-052 · Blocks approval · Citation checked against stored text
A product labeled "for research use only" but sold with dosing guides, stacks or shipping to consumers is a drug marketed for human use. FDA reads intended use from the circumstances of sale, not from the label disclaimer. Most of these peptides are not approved for any use, and several are on FDA's list of bulk substances that raise safety concerns for compounding.
Source: FDCA 201(g)(1); 21 CFR 201.128 (intended use is shown by the circumstances of sale); FDA bulk drug substances guidance for compounding (503A); FTC Act section 5
Safer wording: Do not sell or describe unapproved peptides for human use. If a peptide is a prescription drug that a licensed pharmacy compounds for a patient with a prescription, say that, and make no performance claims.
21 CFR 201.128 · Needs counsel review

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