This guide is currently available in English. A Spanish version is in progress.
State ordering guide
Sourcing Exosomes in California
Licensed California practices order Kimera exosome material from ExaVeyra as research-grade product, shipped cold-chain from Miami Beach with a Certificate of Analysis and lot traceability on every vial. California buyers need their own professional license and NPI; the nonresident wholesaler license is the supplier’s obligation, not the purchaser’s.
California differs from most states in two respects worth knowing before you set up. Its stem cell law is a disclosure requirement rather than a permission, and it defines its subject by reference to the federal HCT/P category. Separately, California enforces the corporate practice of medicine doctrine more strictly than almost anywhere, so entity structure is decided early rather than late.
At a glance
| Question | Answer |
|---|---|
| Does ExaVeyra ship to California? | Yes. Cold-chain from Miami Beach, as we do to all 50 states |
| Cold-chain transit from Miami | 1 to 3 business days |
| State regenerative-medicine statute | SB 512 (2017) |
| Does that statute reach exosomes? | No. It covers cells and tissues; exosomes are governed federally |
| Physician delegation required to hand off medical acts | Yes |
| Who holds the wholesale distribution permit | The supplier, not the purchasing practice |
| Last reviewed | 9 August 2026 |
Ordering from California
ExaVeyra ships to licensed practices in all 50 states, California included. Distribution-side licensing is handled by us, so your practice orders against its own professional license and NPI. What varies state to state is not whether product can reach you, but the indications it may be used for under federal law and how California regulates who performs the procedure.
What your practice provides
- An active California professional license in good standing, verifiable through the relevant board.
- A valid NPI, which ExaVeyra verifies at account setup.
- A signed research-use acknowledgment on file for exosome material.
- A California resale certificate if the practice is purchasing for resale rather than for use in its own operations.
How the state permits wholesale distribution
California reaches further than most states here. Section 4161 treats anyone located outside California who ships, sells, mails, warehouses, distributes, or delivers dangerous drugs or dangerous devices into the state as a nonresident wholesaler, and requires a Board of Pharmacy license before doing so. Devices are inside the definition, where Florida for example requires no wholesale permit for devices. A separate license is required for each place of business, and the applicant maintains a valid license in its home state, with NABP Drug Distributor Accreditation available as an alternative route in some circumstances. The license sits with the distributor, not with the purchasing practice.
Cal. Bus. & Prof. Code § 4161 · California State Board of Pharmacy
California regenerative-medicine law
California enacted SB 512, codified at Cal. Bus. & Prof. Code § 684, effective 1 January 2018.
Health care practitioners licensed under division 2 of the Business and Professions Code who perform stem cell therapies not approved by the FDA. The required notice reads: “THIS NOTICE MUST BE PROVIDED TO YOU UNDER CALIFORNIA LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a stem cell therapy.” The section does not apply to a practitioner who has obtained FDA approval or clearance for an investigational new drug, or an investigational device exemption, for the use of HCT/Ps.
- Posted notice in the office entrance and a patient-visible area
- Written notice before the initial therapy
- Notice at least 8.5 by 11 inches in no less than 40-point type
“a therapy involving the use of HCT/Ps”
How this applies to exosomes
California is the clearest state in the country on this point, because section 684 defines its subject rather than leaving it to inference. It defines stem cell therapy as a therapy involving the use of HCT/Ps, the federal category of human cells, tissues, and cellular and tissue-based products regulated under 21 C.F.R. part 1271. Exosomes are acellular extracellular vesicles and are not HCT/Ps, so the section’s notice requirement is written around a category exosomes do not fall into. That is a statement about what the disclosure law covers, not a statement that exosome products sit outside regulation. They remain governed by federal law, under which no exosome product has been approved by the FDA for administration to humans. ExaVeyra supplies Kimera material for topical aesthetic use in clinics and for research applications, with full COA and lot documentation.
Who can handle product in a California practice
California runs on two documents rather than a single standing protocol. An authorized clinician performs a good faith examination of the individual patient, then issues a patient-specific order; only after that order exists may a delegated provider administer the treatment within their own scope. Documenting both steps per patient is the practical difference between California and states that rely on a general standing delegation order.
| Role | Scope under state law |
|---|---|
| MD / DO | Physicians licensed by the Medical Board of California may perform medical acts within their scope and are the source of any delegation. Aesthetic procedures that constitute the practice of medicine sit inside that framework. |
| NP / APRN | Nurse practitioners may perform the good faith examination, issue patient-specific orders, and delegate to registered nurses within their scope. Assembly Bill 890 established pathways under which qualifying NPs may practice without standardized procedures, subject to the transition-to-practice and certification requirements the statute sets. |
| PA | Physician assistants practice under a practice agreement with a supervising physician and may perform the good faith examination within that agreement. |
| RN | Registered nurses may administer a treatment only after an authorized clinician has performed the good faith examination and issued a patient-specific order, and then only within the RN scope of practice. An RN does not perform the examination or set the treatment plan. |
Good faith examination
California treats the good faith examination as a baseline requirement before any delegated medical aesthetic procedure. The examining clinician assesses the patient, confirms the treatment is appropriate, and rules out contraindications. Only a physician, nurse practitioner, or physician assistant may perform it. A registered nurse may not, because the examination involves diagnosis and treatment planning that fall outside the RN scope. The examination may be conducted in person or by compliant synchronous telehealth.
Ownership and clinic licensing
Entity structure is decided early in California. The medical side of a practice is owned and controlled by licensed clinicians rather than by investors or a lay company, and it takes the form of a professional corporation rather than an LLC. Under the Moscone-Knox Professional Corporation Act a physician holds at least 51 percent of a professional medical corporation and a nurse practitioner may hold no more than 49 percent. Practices commonly pair the professional corporation with a separate management services organization. Assembly Bill 890 created a pathway for qualifying nurse practitioners to practice without standardized procedures and to form their own professional nursing entity, but it did not change the ownership ceiling inside a professional medical corporation. Structure this with California counsel.
Cold chain into California
Shipments dispatch from our Miami Beach facility under validated temperature monitoring, and delivery into California is scheduled to avoid a weekend hold at the carrier hub.
| Metro | County | Notes |
|---|---|---|
| Los Angeles | Los Angeles | Largest aesthetic market in the country, with dense dermatology and med spa coverage. |
| Orange County | Orange | Newport Beach and Irvine corridor with a high concentration of aesthetic practices. |
| San Diego | San Diego | Strong regenerative and longevity segment alongside aesthetics. |
| San Francisco | San Francisco | Bay Area concierge and longevity practices. |
| San Jose | Santa Clara | South Bay market serving the Silicon Valley corridor. |
| Sacramento | Sacramento | Central Valley hub with a growing aesthetic segment. |
- California orders of fifteen or more cold-chain units ship free nationwide; see the volume program for current thresholds.
- Inspect the temperature indicator on arrival and contact us before use if the shipment reads outside range.
- Storage and handling conditions for each product are stated on its Certificate of Analysis.
Practice types we supply in California
California licensing and verification
Medical Board of California
Physician license verification and enforcement actions.
California Board of Registered Nursing
California State Board of Pharmacy
Issues the nonresident wholesaler license held by out-of-state suppliers.
California Department of Tax and Fee Administration
Where a practice registers before issuing a resale certificate.
California sourcing questions
- Does California’s stem cell disclosure law apply to exosomes?
- Section 684 of the Business and Professions Code defines stem cell therapy as a therapy involving the use of HCT/Ps, the federal category of human cells, tissues, and cellular and tissue-based products under 21 C.F.R. part 1271. Exosomes are acellular and are not HCT/Ps, so the notice requirement is written around a category they do not fall into. Exosome products remain governed by federal law, and no exosome product is FDA-approved for administration to humans.
- Who can perform the good faith exam in California?
- A physician, nurse practitioner, or physician assistant. A registered nurse may not, because the examination involves diagnosis and treatment planning outside the RN scope. Once the examining clinician issues a patient-specific order, a registered nurse may administer the treatment within their own scope. The examination may be in person or by compliant synchronous telehealth.
- Can a non-physician own a med spa in California?
- The medical side is owned and controlled by licensed clinicians through a professional corporation rather than an LLC. Under the Moscone-Knox Professional Corporation Act a physician holds at least 51 percent of a professional medical corporation and a nurse practitioner may hold no more than 49 percent. Practices commonly pair the professional corporation with a separate management services organization. Structure this with California counsel.
- Does my California clinic need a wholesaler license to buy exosomes?
- No. The nonresident wholesaler license under section 4161 is held by the out-of-state distributor shipping into California, not by the practice buying. Your practice orders against its own professional license and NPI. ExaVeyra handles distribution-side licensing.
- How is California’s wholesaler rule different from other states?
- It is broader. Section 4161 reaches dangerous drugs and dangerous devices, and requires a separate license for each place of business a distributor ships from. Florida, by contrast, requires no wholesale distributor permit for devices at all. This affects which suppliers can lawfully ship into California, which is worth confirming with any vendor you use.
- How long does cold-chain shipping take to California?
- Overnight from our Miami Beach facility once prepared, with preparation taking one to two business days. All exosome shipments travel cold-chain with validated temperature monitoring, and deliveries are scheduled to avoid a weekend hold at the carrier hub.
Sources
Last reviewed 9 August 2026 by ExaVeyra Sciences editorial team. Every claim above links to a primary source.
- Cal. Bus. & Prof. Code § 684, stem cell therapy disclosure (accessed 8 August 2026)
- California SB 512 (2017), bill text (accessed 8 August 2026)
- Cal. Bus. & Prof. Code § 4161, nonresident wholesalers (accessed 8 August 2026)
- California State Board of Pharmacy, nonresident wholesaler application (accessed 8 August 2026)
- Medical Board of California (accessed 8 August 2026)
- California Department of Tax and Fee Administration (accessed 8 August 2026)
- FDA Public Safety Notification on Exosome Products (accessed 8 August 2026)
These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. There are no FDA-approved exosome products. Biomolecular signaling vesicle products distributed by ExaVeyra Sciences are supplied for topical aesthetic treatments in clinics and for medical, molecular biology, and biochemistry research applications, and are not tissue products as defined by FDA guidelines.
This page summarizes publicly available state requirements for licensed practitioner education. It is not legal advice, medical advice, or regulatory guidance, and it does not establish that any particular practice is compliant. Requirements change. Confirm current federal and state obligations with qualified counsel before offering any regenerative service line.