Peptides (therapeutic)
Therapeutic peptides are short chains of amino acids used as drugs — a spectrum running from fully approved medications (GLP-1s are peptides) to investigational compounds like BPC-157 whose compounding status is actively being decided.
- Spectrum: approved drugs → compoundable-today catalog → compounds awaiting rulemaking
- NAD+, sermorelin, and oxytocin anchor programs running today
- BPC-157 and peers await FDA rulemaking after PCAC votes
- Research-use-only material is not a lawful clinical supply
One word, three regulatory realities
The category spans a spectrum — and the middle of it is a working market today. At one end sit approved peptide drugs: semaglutide, tirzepatide, insulin, oxytocin, tesamorelin. In the middle is the compoundable catalog behind today’s thriving peptide programs — substances that are components of approved drugs, carry USP monographs, or sit in Category 1 of the FDA’s bulks evaluation, with NAD+ and sermorelin among the best known. And a closely watched tail — BPC-157, TB-500, and peers — is now on a visible path to clarity after the July 2026 PCAC votes. The scrutiny in that tail concentrates on research-use-only material sold outside pharmacy and clinician channels entirely.
Where the category is heading
The July 2026 PCAC votes recommending six peptides for the 503A bulks list are the strongest signal yet that the category’s most popular compounds are headed for a clear, rulemaking-backed pathway. Rulemaking takes time — but demand hasn’t waited, and neither have operators: peptide care is one of the fastest-growing categories in DTC health, built on clinician-directed protocols, honest consent language, and diligent sourcing. That structure is exactly what turns each newly cleared substance into a same-week catalog addition.
The working catalog, by example
The middle of the spectrum is a real market today — these are the statuses that matter:
| Peptide | Status | Basis |
|---|---|---|
| Semaglutide / tirzepatide | Approved drugs | FDA-approved products (they are peptides) |
| Oxytocin | Compoundable | Component of a long-approved drug |
| NAD+ | Compoundable today | Category 1 of the FDA bulks evaluation |
| Sermorelin | Compoundable today | Category 1 of the FDA bulks evaluation |
| BPC-157 | Awaiting rulemaking | Favorable PCAC vote, July 2026 |
| TB-500 | Awaiting rulemaking | Favorable PCAC vote, July 2026 |
Sourcing quality: the questions that matter
Peptide quality lives in the supply chain. The questions that separate real programs from risk: Is the API from an FDA-registered supplier? Does every lot carry a certificate of analysis, and does the pharmacy verify it? Does the pharmacy run its own potency and sterility testing on finished preparations? Research-use-only material fails every one of those questions by definition — which is exactly why the pharmacy-and-clinician channel is the moat, not the obstacle.
Compliance handled, so you can build
Lithos runs the clinicians, pharmacies, and 50-state rules behind your care program — one API.
Frequently asked questions
Are peptide programs legal?
Yes — a real catalog is offerable today: NAD+, sermorelin, oxytocin, and other compoundable peptides, delivered through clinician review, pharmacy-based sourcing, and honest consent language. The risk in the category concentrates in research-use-only material sold outside pharmacy and clinician channels entirely.
Is BPC-157 legal now?
Its PCAC recommendation is advisory — until FDA rulemaking adds it to the bulks list and compliant supply exists, its compounding status is unchanged.
What should a peptide program do while rulemaking runs?
Grow on today’s catalog with clinician-directed protocols, keep sourcing and consent tight, and treat each future clearance as a same-week catalog addition. The category is moving — being mid-flight when it does is the whole advantage.