This guide is currently available in English. A Spanish version is in progress.
State ordering guide
Sourcing Exosomes in Pennsylvania
Licensed Pennsylvania practices order Kimera exosome material from ExaVeyra as research-grade product, shipped cold-chain from Miami Beach with lot traceability on every vial and a certificate of analysis issued for every lot and provided on request. Pennsylvania buyers need their own professional license and NPI; the nonresident pharmacy registration and the drug distribution registrations the Commonwealth issues sit with the shipping supplier rather than with the purchasing practice.
Two Pennsylvania points are worth settling early. The Commonwealth has no stem cell practice statute, so there is no state definition to read exosomes into or out of. And certified registered nurse practitioners here work in collaboration with a physician rather than under supervision, which the Board made explicit by rescinding its supervision rule after the legislature removed supervision from the statute.
At a glance
| Question | Answer |
|---|---|
| Does ExaVeyra ship to Pennsylvania? | 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 | None |
| Does that statute reach exosomes? | No. Its definition is written around cells; exosomes are acellular and governed federally |
| Physician delegation required to hand off medical acts | Yes |
| Who holds the wholesale distribution permit | The supplier, not the purchasing practice |
| What ExaVeyra supplies here | Kimera exosome material and 503A compounded preparations |
| Last reviewed | 11 September 2026 |
Ordering from Pennsylvania
ExaVeyra ships to licensed practices in all 50 states, Pennsylvania included. Distribution-side licensing is the supplier’s obligation rather than the purchasing practice’s, so your practice orders against its own professional license and NPI, and ExaVeyra confirms the destination-specific licensure of its supply chain before a first order ships. What changes state to state is how the state regulates who performs a procedure and how the practice itself is owned, while federal law governs the product itself.
What your practice provides
- An active Pennsylvania professional license in good standing, verifiable through the Department of State’s licensee search.
- A valid NPI, which ExaVeyra verifies at account setup.
- A signed research-use acknowledgment on file for exosome material.
- A Pennsylvania Exemption Certificate, Form REV-1220, if the practice is purchasing for resale rather than for use in its own operations.
How the state permits wholesale distribution
Pennsylvania splits supplier licensing across two agencies. The State Board of Pharmacy, within the Department of State, registers nonresident pharmacies under section 4.1 of the Pharmacy Act. A nonresident pharmacy is any pharmacy located outside the Commonwealth that ships, mails or delivers legend drugs or legend devices into it pursuant to a prescription order, and it operates on a certificate of registration the Board may deny, revoke or suspend if the pharmacy’s home-state permit was suspended or revoked or it was otherwise disciplined there. The Act also reaches promotion rather than only supply: it is unlawful for a nonresident pharmacy without a certificate of registration to advertise its services in the Commonwealth, and unlawful for a Pennsylvania resident to advertise the services of such a pharmacy knowing the advertisement is likely to induce members of the public here to use it. Separately, the Department of Health administers drug distribution through its Drug, Device and Cosmetic Program, and the Wholesale Prescription Drug Distributors License Act of 1992 requires a license to operate a facility within the Commonwealth from which a person engages in the wholesale distribution of prescription drugs. Because that Act is written around in-Commonwealth facilities while the Department separately registers out-of-state distributors, a practice confirming a supplier’s position should ask the Department which registrations that supplier holds rather than inferring it from either authority alone.
63 P.S. § 390-4.1; 63 P.S. § 391.1 et seq. · Pennsylvania State Board of Pharmacy
Pennsylvania regenerative-medicine law
Pennsylvania has not enacted a statute specific to stem cell or regenerative therapies. Practice in this area is governed by the state's general medical practice and professional licensing rules, alongside federal law.
Pennsylvania has not enacted a statute governing stem cell or regenerative services in a practice, and it has not enacted a disclosure law of the kind Washington passed in 2018. A Pennsylvania practice adding a service line therefore finds its rules in the general professional licensing scheme: the Medical Practice Act of 1985 and the State Board of Medicine’s regulations, the Osteopathic Medical Practice Act and its board’s regulations, the Professional Nursing Law and the CRNP rules in 49 Pa. Code Chapter 21, and the physician assistant rules in Chapter 18. Facility questions sit with the Department of Health rather than with the licensing boards.
How this applies to exosomes
Pennsylvania has no statute that authorises or requires a disclosure for stem cell services in a practice, so there is no state definition to read exosomes into or out of, and no state notice requirement to satisfy. Exosome products are governed by federal law, under which no exosome product has been approved by the FDA for administration to humans. The state-level questions a Pennsylvania practice actually faces are which professional may perform which act, and how the entity is owned and named. One Pennsylvania rule is worth reading before a service line is promoted rather than after: the Pharmacy Act makes it unlawful for an unregistered nonresident pharmacy to advertise its services in the Commonwealth and for a Pennsylvania resident to advertise such a pharmacy’s services, which is a constraint on marketing and not only on shipping. ExaVeyra supplies Kimera material for topical aesthetic use in clinics and for research applications, with lot documentation and a certificate of analysis for every lot.
Who can handle product in a Pennsylvania practice
Pennsylvania runs two different relationships and the words matter. A physician assistant is supervised, by a physician registered with the Board for that purpose and under a written agreement filed with it. A certified registered nurse practitioner collaborates, under an agreement with a Pennsylvania-licensed physician, and supervision was removed from the nursing scheme by statute in 2002 and from the regulations when the Board rescinded § 21.287. Neither route is independent practice, so a Pennsylvania practice planning a service line needs a physician in the structure either way. Confirm your own protocols with Pennsylvania counsel.
| Role | Scope under state law |
|---|---|
| MD / DO | Physicians licensed by the State Board of Medicine, and osteopathic physicians licensed by the State Board of Osteopathic Medicine, perform medical acts within their scope. A physician who wishes to work with a physician assistant registers with the Board as a primary supervising physician and files the written agreement; a physician who works with a certified registered nurse practitioner enters a collaborative agreement rather than supervising. |
| NP / APRN | Certified registered nurse practitioners collaborate; they are not supervised, and they do not hold independent practice authority. A CRNP may collaborate only with physicians currently licensed in Pennsylvania, and when acting in collaboration within the CRNP’s specialty may perform comprehensive assessments and establish medical diagnoses. The distinction is deliberate rather than semantic: the Board rescinded 49 Pa. Code § 21.287, the physician supervision section, because the General Assembly deleted the supervision provisions in its December 2002 amendments to the Professional Nursing Law. Prescriptive authority runs on a separate written collaborative agreement under 49 Pa. Code § 21.285, which identifies the collaborating physician and at least one substitute physician who collaborates when the first is unavailable, and carries both signatures with the date signed and the effective date. |
| PA | Physician assistants practise under a registered supervising physician. Under 49 Pa. Code § 18.143, amended 3 July 2025 and effective 5 July 2025, the Board registers a primary supervising physician who holds an unrestricted Pennsylvania licence, has filed the registration form together with the written agreement required by § 18.142, and has named at least one other physician serving as a substitute. That substitute is not a formality: a physician assistant must refrain from practising when the primary supervising physician is permanently unable to supervise unless a substitute is named in the written agreement on file with the Board. The Board maintains a current public list of registered primary supervising physicians, the assistants under each, and the substitute named for each. |
| RN | Registered nurses practise under the Professional Nursing Law and carry out a medical regimen prescribed by a practitioner authorised to prescribe. Confirm the current scope position for cosmetic and aesthetic procedures with the State Board of Nursing before building a protocol, since the Board addresses these through its own guidance rather than through a dedicated regulation. |
Good faith examination
Pennsylvania does not use the phrase “good faith examination” as a statutory term. The functional requirement follows from the two relationships: a physician assistant acts within the written agreement filed with the Board, and a certified registered nurse practitioner performs the comprehensive assessment and establishes the diagnosis within their specialty under the collaborative agreement. Confirm current expectations with the State Board of Medicine and the State Board of Nursing.
Ownership and clinic licensing
Pennsylvania has no statute expressly prohibiting the corporate practice of medicine, and its board rules are permissive but procedural. Under 49 Pa. Code § 25.214 a licensee may hold ownership interests in businesses formed to provide goods or services related to the practice of medicine where not otherwise prohibited and where the disclosure requirements of the act of 26 May 1988 are met, may form partnerships or professional corporations for the practice of medicine with other licensed physicians and with optometrists, dentists, psychologists, podiatrists and chiropractors where the incorporation is separately authorised, and may practise under a fictitious name that is not misleading, deceptive, untrue or fraudulent. One step is easy to miss and is not optional: before filing with the Corporation Bureau of the Department of State, a licensee must first file the corporate documents with the Board for review and approval. Structure the entity with Pennsylvania counsel, and build that Board review into the timeline before opening.
Cold chain into Pennsylvania
Shipments dispatch from our Miami Beach facility under validated temperature monitoring, and delivery into Pennsylvania is scheduled to avoid a weekend hold at the carrier hub.
| Metro | County | Notes |
|---|---|---|
| Philadelphia | Philadelphia | Largest concentration of dermatology, aesthetic and concierge practices in the state. |
| Pittsburgh | Allegheny | Western Pennsylvania hub with academic and independent practices. |
| Main Line | Montgomery and Delaware | Suburban Philadelphia corridor with a dense med spa and concierge market. |
| Allentown and Bethlehem | Lehigh and Northampton | Lehigh Valley market with a broad clinical mix. |
| Harrisburg | Dauphin | Capital market serving central Pennsylvania. |
| Scranton | Lackawanna | Northeastern Pennsylvania market with growing aesthetic coverage. |
- Pennsylvania 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 Pennsylvania
Pennsylvania licensing and verification
Pennsylvania State Board of Medicine
Licenses physicians and physician assistants and registers supervising physicians.
Pennsylvania State Board of Osteopathic Medicine
A separate board licenses osteopathic physicians and publishes the corporate practice rule at 49 Pa. Code § 25.214.
Pennsylvania State Board of Nursing
Licenses RNs and CRNPs and approves prescriptive authority collaborative agreements.
Pennsylvania State Board of Pharmacy
Registers nonresident pharmacies shipping legend drugs into the Commonwealth.
PA Department of Health, Drug, Device and Cosmetic Program
Registers drug and device distributors and administers the 1992 wholesale distributor licensing act.
Pennsylvania sourcing questions
- Does Pennsylvania have a stem cell law that covers exosomes?
- No. Pennsylvania has not enacted a statute governing stem cell or regenerative services in a practice, and it has no disclosure law of the kind Washington passed in 2018, so there is no state definition to read exosomes into or out of and no state notice to give. Exosome products are governed by federal law, under which no exosome product is FDA-approved for administration to humans. The state-level questions are which professional may perform which act, and how the entity is owned and named.
- Does my Pennsylvania clinic need a pharmacy or distributor registration to buy exosomes?
- No. Those sit with the out-of-state supplier, and Pennsylvania splits them across two agencies: the State Board of Pharmacy registers a nonresident pharmacy under section 4.1 of the Pharmacy Act, and the Department of Health registers drug and device distributors through its Drug, Device and Cosmetic Program. Your practice orders against its own professional license and NPI, and ExaVeyra confirms destination licensure across its supply chain before a first order ships.
- Can my Pennsylvania practice source 503A compounded peptides through ExaVeyra?
- Yes. Compounded formulations are prepared by our 503A pharmacy partner, a compounding pharmacy licensed by the Texas State Board of Pharmacy, and it holds the Pennsylvania nonresident pharmacy registration that section 4.1 of the Pharmacy Act requires of a pharmacy shipping legend drugs into the Commonwealth pursuant to a prescription order. That registration sits with the pharmacy rather than with your practice; the State Board of Pharmacy is where a practice confirms it, and we confirm current status for your destination before the first prescription is placed.
- Do nurse practitioners work under supervision in Pennsylvania?
- No, they collaborate, and the distinction is deliberate rather than semantic. The General Assembly deleted the physician supervision provisions from the Professional Nursing Law in its December 2002 amendments, and the Board then rescinded 49 Pa. Code § 21.287, the supervision section, because it had been written under the old scheme. A certified registered nurse practitioner collaborates with a Pennsylvania-licensed physician and, within their specialty, performs comprehensive assessments and establishes medical diagnoses. This is not independent practice: the collaborative agreement is mandatory, and prescriptive authority runs on a separate written agreement naming the collaborating physician and at least one substitute.
- Who in a Pennsylvania practice can handle exosome material?
- Both routes require a physician in the structure, but they are different relationships. A physician assistant is supervised by a physician the Board has registered for that purpose under 49 Pa. Code § 18.143, with the written agreement on file and at least one substitute physician named; the assistant must stop practising if the primary supervising physician becomes permanently unable to supervise and no substitute is on file. A certified registered nurse practitioner acts under a collaborative agreement rather than supervision. Registered nurses carry out a regimen prescribed by an authorized practitioner. Confirm your own protocols with Pennsylvania counsel.
- What does ExaVeyra verify before opening a Pennsylvania account?
- An active Pennsylvania professional license checked through the Department of State’s licensee search, a valid NPI, and a signed research-use acknowledgment for exosome material. Practices buying for resale also provide a Pennsylvania Exemption Certificate, Form REV-1220.
- How should exosome material be handled on arrival?
- Check the temperature indicator included with the shipment before the vials go into storage, and move them to their storage condition promptly. If the indicator reads outside range, contact us before use rather than storing the shipment. Storage and handling conditions for each product are stated on its Certificate of Analysis, and every vial carries its lot number.
Material available to licensed Pennsylvania practices
Kimera Labs preparations distributed by ExaVeyra, characterised on the certificate of analysis supplied with every lot. Research-grade material for licensed practices; the practitioner determines clinical use.
- Luxir
1 Trillion Microvesicles · 5 Trillion Microvesicles
Available formats: 1.0 mL, 5.0 mL
- Luxir+
3 Trillion Microvesicles · 15 Trillion Microvesicles
Available formats: 1.0 mL, 5.0 mL
- Kiara
3 mg secretome · 15 mg secretome
Available formats: 1.0 mL, 5.0 mL
- Vive
2 Trillion Microvesicles
Available formats: 5.0 mL
Sources
Last reviewed 11 September 2026 by ExaVeyra Sciences editorial team. Every claim above links to a primary source.
- Pharmacy Act, Act of 27 September 1961, P.L. 1700, No. 699 (nonresident pharmacies at section 4.1) (accessed 11 September 2026)
- Wholesale Prescription Drug Distributors License Act, Act of 14 December 1992, P.L. 1116, No. 145 (accessed 11 September 2026)
- PA Department of Health, Drug, Device and Cosmetic Program (accessed 11 September 2026)
- 49 Pa. Code Chapter 27, State Board of Pharmacy (accessed 11 September 2026)
- 49 Pa. Code Chapter 21, Subchapter C, certified registered nurse practitioners (accessed 11 September 2026)
- 49 Pa. Code § 21.285, prescriptive authority collaborative agreements (accessed 11 September 2026)
- 49 Pa. Code § 18.143, criteria for registration as a supervising physician (accessed 11 September 2026)
- 49 Pa. Code § 25.214, corporate practice and fictitious names (accessed 11 September 2026)
- Pennsylvania State Board of Pharmacy (accessed 11 September 2026)
- FDA Public Safety Notification on Exosome Products (accessed 11 September 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.
Reference only. Not 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.
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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.
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