Regulatory and legal notices

Product status. Biomolecular signaling vesicles (exosomes) supplied by ExaVeyra Sciences are not approved, cleared, or licensed by the United States Food and Drug Administration. No exosome product has been approved by the FDA for administration to humans for any indication. Statements on this page have not been evaluated by the FDA.

Intended use. This material is not intended for the diagnosis, cure, mitigation, treatment, or prevention of any disease or condition. ExaVeyra Sciences does not offer, recommend, or authorize its use for any such purpose, and makes no representation as to administration, route, frequency, or clinical outcome.

Who may purchase. ExaVeyra Sciences sells only to licensed healthcare practitioners and to the practices that employ them, following verification of an active professional license and National Provider Identifier. Nothing on this page is an offer to sell to a consumer or patient.

Professional responsibility. The purchasing practitioner is solely responsible for determining whether, how, and in what setting any material may lawfully be used, and for compliance with the law of the jurisdiction in which they practice. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. No practitioner-patient relationship is created by use of this website.

Jurisdiction. This website is directed to viewers in the United States and Puerto Rico. Federal law governs the regulatory status of this material throughout both, including Puerto Rico, which is subject to the Federal Food, Drug, and Cosmetic Act on the same terms as the several states. State and territorial law governs professional licensure, scope of practice, and what a practitioner may lawfully offer, and those rules differ. Availability and permitted use vary accordingly. Nothing on this page is legal or medical advice.

The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.

ExaVeyra Sciences publishes these guides as a reference for licensed practitioners. They summarize publicly available federal and state requirements as those requirements read on the review date shown above. The content is provided for general informational purposes only and does not constitute legal, medical, or regulatory advice, and it does not establish that any particular product or practice is compliant.

No attorney-client relationship, and no professional or clinical relationship of any kind, is created by accessing these materials. ExaVeyra Sciences is a supplier of research-use materials. It is not a law firm, it is not a regulatory consultant, and it takes no part in any diagnosis, treatment decision, or plan of care. Each practitioner is responsible for retaining their own legal counsel and for determining, with that counsel and the applicable state licensing boards, how the requirements described here apply to the services, staffing, and structure of their own practice.

Statutes, regulations, board rules, and agency positions are subject to amendment, supersession, and reinterpretation. ExaVeyra Sciences makes no representation or warranty as to the accuracy, completeness, timeliness, or applicability of this content to any particular practice. Citations and links to third-party sources are provided for convenience only and do not constitute an endorsement of their content.

The practitioner and the practice are solely responsible for compliance with all applicable licensing, scope of practice, supervision, ownership, facility, recordkeeping, and tax requirements, and for all clinical decisions, including the suitability of any material for a given patient. To the fullest extent permitted by law, ExaVeyra Sciences disclaims all liability for any action taken or not taken in reliance on this content.

This page is provided for informational purposes only. It is not medical advice, it is not intended to diagnose, treat, cure, or prevent any disease, and it is not a substitute for the judgment of a licensed practitioner. Consult a healthcare professional before acting on anything stated here.

The FDA has not approved GHK-Cu or any exosome product for hair loss or any form of alopecia. Compounded medications are not FDA-approved; they are prepared by a licensed 503A compounding pharmacy for an individual patient against that patient’s prescription, and they are supplied to NPI-verified licensed practitioners only. Where this page discusses an FDA-approved active such as oral finasteride or topical minoxidil, the approved product’s labeling governs and nothing here modifies it.

Exosome material is supplied for Research Use Only. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome.

ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. ExaVeyra Sciences does not supply controlled substances. Findings described on this page are attributed to the peer-reviewed literature and to the agencies cited, and a citation establishes that a question was studied, not that any product is suitable for a given patient. The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.