Regulatory rules that determine how peptides can be approved, compounded, marketed, and enforced.
Section 503A exempts certain compounded drugs from FDA approval and manufacturing requirements if the drug is compounded for an identified patient, uses allowable bulk drug substances, and is not essentially a copy of a commercially available drug.
Section 503B allows FDA-registered outsourcing facilities to compound drugs without patient-specific prescriptions, but the bulk drug substance must be on the 503B bulk list or a component of an FDA-approved drug, and the product must not be essentially a copy of an approved drug.
When FDA determines a drug is in national shortage, certain compounding restrictions are relaxed. When the shortage resolves, those exceptions end after any announced transition period.
A drug must have an FDA-approved application in effect before it can be legally introduced into interstate commerce, unless a specific exemption applies. Approval is granted to a specific product, indication, route, strength, and dosage form.
Health claims for drugs must be supported by substantial evidence and must not misstate FDA approval status. The FTC requires adequate substantiation for health claims, and the FDA can act against false or misleading drug claims.
A 'research use only' label does not make an unapproved drug lawful for human use. FDA evaluates the seller's intended use, including website claims, to determine whether the product is a drug intended for human use.