Two ratings, kept separate on purpose.
Legality and evidence are different questions. A compound can be perfectly legal to compound and barely studied in humans — or heavily studied and not lawfully compoundable. So we grade both, and never let one stand in for the other.
THE TIER — WHERE IT STANDS
FDA-approved / recognized
Approved products, or substances with established human-trial support. Prescribe and compound within the normal rules.
22 compoundsCompoundable · emerging data
Lawfully compoundable under 503A/503B with a legitimate evidence base, but outside a full FDA approval. Use with informed consent.
6 compoundsInformation only
Research compounds with thin or preclinical-only human data, or an unsettled compounding status. Documented here for transparency — not a recommendation.
46 compoundsTHE GRADE — HOW GOOD THE HUMAN DATA IS
503A vs 503B — the two compounding lanes
Most of what makes a peptide lawfully available (or not) comes down to these two sections of the Food, Drug & Cosmetic Act. A compound can qualify for one and not the other.
503A pharmacies
Compound patient-specific prescriptions. To be made here legally, a bulk drug substance generally has to be the subject of an approved application, appear in the USP, or sit on FDA's 503A bulks list. We flag each compound's 503A standing.
503B outsourcing facilities
Register with FDA and compound larger batches under cGMP, often for office use without a patient-specific script — but only from substances on FDA's separate 503B list (or in shortage). Different list, different rules.
Status changes
FDA nominations, PCAC votes, and shortage listings shift which lane a compound fits. We note the standing as of each page's date — always verify current status before prescribing or compounding.