Educational scope and regulatory context

Information published on this website is provided for general educational and informational purposes only. It is not medical, diagnostic, prescribing or treatment advice, and it is not a substitute for consultation with a licensed U.S. healthcare professional. Nothing on this site creates a physician–patient relationship. If you have a medical question or concern, please contact a qualified provider licensed in your state.

This site does not promote, market, endorse, sell, offer for sale or recommend any drug, biologic, dietary supplement, medical device or clinical service. References to peptides, molecules, indications or research findings are made for scientific and educational discussion only. No content on this site should be read as an offer, solicitation or inducement to use any specific product.

In the United States, individual peptide products may be approved prescription drugs, investigational agents, compounded preparations, dietary-ingredient candidates, or substances that are not lawfully marketed for human use. Their legal status is determined by the U.S. Food and Drug Administration (FDA) and related federal and state authorities, and it can change over time. This site does not assert that any peptide discussed is approved, safe or effective for any particular use, and it does not distinguish regulatory status on a product-by-product basis. Readers should consult current FDA guidance and product labeling before drawing any clinical conclusion.

Some peptides in U.S. clinical use are prepared by compounding pharmacies operating under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. FDA has, from time to time, placed specific peptide substances on categorization lists that affect whether they may lawfully be compounded. This site does not certify the compounding status of any substance and does not direct readers to any compounder. Clinicians are responsible for verifying current FDA lists and state pharmacy-board rules before prescribing or dispensing.

Off-label prescribing of FDA-approved drugs is lawful in the United States when performed by a licensed practitioner within their scope of practice and based on sound medical judgment. Educational discussion of off-label use on this site is not a recommendation to prescribe. Practitioners remain solely responsible for informed consent, documentation and adherence to state medical-board expectations.

Materials sold in the United States as "research use only," "not for human consumption" or similar are not lawful for administration to people. This site does not condone or facilitate the human use of such materials, and any discussion of research-grade substances is confined to their scientific literature.

Certain peptides and adjacent compounds may be subject to the federal Controlled Substances Act enforced by the Drug Enforcement Administration (DEA), and to additional restrictions imposed by individual state legislatures, boards of medicine, boards of pharmacy and boards of nursing. Legal status varies by state and changes over time. Readers are responsible for determining the law that applies to them.

Peptide-containing products marketed in the United States as dietary supplements are regulated under a separate framework (DSHEA) and are not reviewed by FDA for safety or efficacy before sale. Statements about such products on this site — where they appear at all — are educational, are not evaluated by FDA, and are not intended to diagnose, treat, cure or prevent any disease.

Programmes offered or referenced by the Institute are postgraduate educational activities designed to strengthen scientific understanding, clinical reasoning and professional governance. They are compound-agnostic in orientation: they do not provide prescribing protocols, do not recommend specific products, and do not constitute clinical training in the administration of any therapy. Clinical decisions remain the responsibility of individual U.S.-licensed practitioners operating within their state scope of practice and applicable federal and state law.

The regulatory landscape for therapeutic peptides in the United States is evolving. Content on this site reflects the Institute's understanding at the time of publication and may not be current. The Institute makes no warranty, express or implied, regarding completeness, accuracy or fitness for a particular purpose, and disclaims liability for reliance on this information to the fullest extent permitted by law.

Suspected adverse events involving FDA-regulated products should be reported to the FDA MedWatch program. Suspected unlawful marketing or distribution of drugs may be reported to FDA or to the appropriate state authority. This site is not a channel for reporting adverse events.