Disclaimer: This material is provided for educational and informational purposes only. It does not constitute legal or medical advice or regulatory guidance. Requirements and interpretations may vary and change over time. Always verify current rules directly with the Pennsylvania State Board of Medicine, State Board of Osteopathic Medicine, Pennsylvania Department of State (BPOA), and the Pennsylvania Department of Health (DOH), and consult qualified legal counsel before taking action.
Executive Summary
- Pennsylvania requires that medical procedures in medspas be directed and supervised by a Pennsylvania-licensed physician (MD or DO) with real clinical authority, not just a title.
- Delegation and supervision must be documented, including written protocols, competency validation, and quality-assurance processes for injectables, devices, IV therapy, telehealth, and weight-loss services.
- CRNPs and PAs may practice and prescribe only under written collaborative or supervisory agreements, which must be current, accurately reflect scope, and be properly filed or maintained.
- Injectables, lasers, energy-based devices, and advanced aesthetic services are treated as medical acts, requiring licensed clinicians, physician or CRNP oversight, and documented training.
- Ownership structures are scrutinized to ensure nonphysicians do not control medical judgment, clinical policies, or supervision, consistent with Pennsylvania’s prohibition on unlicensed practice.
- Quality assurance, chart review, and accurate marketing are recurring enforcement focus areas in Pennsylvania Board investigations.
- This guide consolidates what Pennsylvania regulators actually expect to see—from agreements and protocols to QA records and governance documents—to help medspas build defensible, audit-ready compliance systems.
Pennsylvania closely regulates who may perform medical procedures, how delegation and supervision must occur, and what documentation must support injectables, energy-based devices, telehealth services, and weight-loss prescribing. Without clear protocols, current collaborative or supervisory agreements, and documented physician involvement, medspas may face Board complaints, regulatory investigations, or allegations of unlicensed practice.
This guide brings together the key compliance elements—medical director eligibility, delegation standards, CRNP and PA collaboration, injectables and device oversight, and common ownership structures reviewed by Pennsylvania regulators. Where relevant, we link directly to applicable statutes, regulations, and official regulatory resources.
Pennsylvania Quick Compliance Checklist (Medspas)
- A Pennsylvania-licensed physician retains control of all medical decision-making, including diagnosis, treatment, prescribing, and clinical protocols.
- MSO agreements must keep business functions (marketing, payroll, supplies) separate from medical authority and clinical judgment.
- Policies and organizational documents must reflect that only licensed clinicians perform medical procedures, consistent with unlicensed practice prohibitions.
- Active, unencumbered Pennsylvania MD or DO license (verify via PALS):
- Experience or documented training relevant to aesthetics and device-based procedures offered.
- Availability for supervision, chart review, and escalation as defined in written policies and agreements.
- Written CRNP collaborative agreement filed and kept current with the State Board (via PALS), as required prior to practice and prescribing.
- Written PA supervising physician agreement outlining scope of delegated tasks, supervision, and prescriptive authority.
- Agreements clearly define:
- Authorized drugs and devices
- Consultation and escalation requirements
- Chart-review frequency
- Documentation expectations
- Agreements must be readily available to the State Board upon request.
- Written scope-of-practice matrix identifying permitted activities for:
- MD/DO
- CRNP
- PA
- RN
- LPN
- Aesthetician/cosmetologist (limited to non-medical services only)
- Each procedure mapped to applicable Pennsylvania licensure rules and delegation protocols to prevent unlicensed practice.
- Procedure-specific protocols for injectables (neuromodulators, fillers), lasers/IPL, RF or microneedling, chemical peels, threads, and IV therapy.
- Emergency-response plans addressing risks such as anaphylaxis, vascular occlusion, burns, or medication reactions.
- Protocols document physician or CRNP oversight, escalation pathways, and required clinical documentation.
- Pennsylvania does not license laser technicians; use of lasers/IPL and similar energy-based devices is generally treated as a medical act requiring physician or CRNP oversight.
- Maintain:
- Physician or CRNP treatment orders
- Written, device-specific protocols
- Training and competency documentation
- Device maintenance and safety logs
- Follow applicable Department of Health guidance and Board expectations.
- Marketing must not imply that estheticians or unlicensed staff perform medical procedures.
- Titles must accurately reflect licensure (avoid misleading terms or implications of independent practice).
- Advertising claims must be truthful, substantiated, and compliant with Pennsylvania’s Unfair Trade Practices and Consumer Protection Law.
- Chart reviews conducted at the frequency specified in collaborative or supervisory agreements.
- Monthly or quarterly QA meeting minutes retained.
- Adverse-event and incident tracking logs maintained.
- Device calibration and maintenance records up to date.
Recordkeeping & Access
- Maintain all collaborative/supervisory agreements, protocols, competency checklists, treatment records, and incident reports.
- Ensure the medical director has timely on-site or remote access to patient records for chart review.
- Retain records in accordance with Board guidance and clinic policy.
Change Management
- Adding a new modality (e.g., RF microneedling, biostimulators, new laser platforms) requires:
- Updated informed consents
- Revised delegation protocols
- Updated collaborative or supervisory agreements (if scope changes)
- Staff retraining and competency validation
- Physician approval prior to clinical launch
The Legal Frame: CPOM + Who Can Be a “Medical Director”?
Who Can Be a Medical Director in Pennsylvania?
Why a “Nonphysician Medical Director” Is Not Permitted
Collaboration & Delegation: CRNPs and PAs in a Pennsylvania Medspa
- Required under 49 Pa. Code §§ 21.285–21.287.
- Must be executed and filed with the Board through PALS before the CRNP practices or prescribes.
- The agreement must define:
- Scope of practice
- Prescriptive authority
- Consultation and emergency protocols
- Quality assurance and chart-review processes
- Governed by 49 Pa. Code §§ 18.141–18.148.
- Must describe delegated medical tasks, prescriptive authority, supervision method, and chart-review expectations.
- Agreements must be maintained and produced to the State Board upon request.
- Remote or alternate-site supervision is permitted if expressly described and supervision remains meaningful.
- Injectables, lasers/IPL, microneedling, and energy-based device procedures are treated as medical acts under Pennsylvania law.
- RNs and LPNs may perform delegated medical tasks only pursuant to:
- Physician or CRNP orders
- Appropriate training and competency validation
- Written clinical protocols and supervision
- Tasks involving independent medical judgment may not be delegated beyond nursing scope.
Injectables & Device Procedures: What Compliance Looks Like in Pennsylvania
Injectables (Botox®, Dermal Fillers, Kybella®, Biostimulators)
- Injectable aesthetic treatments are medical procedures under Pennsylvania law.
- They may be performed only by licensed clinicians (MD/DO, CRNP, PA, RN/LPN under proper orders) with physician or CRNP oversight.
- Documented training, written clinical protocols, and complication-management procedures are required.
Lasers, IPL, RF & Energy-Based Devices
- Lasers, IPL, radiofrequency, and similar energy-based devices are medical devices, and their clinical use is treated as a medical act.
- Compliance requires physician or CRNP orders, device-specific written protocols, documented training, and ongoing competency validation.
- Supervision level depends on the licensure of the individual operating the device.
Microneedling, Chemical Peels, Threads & IV Therapy
- When performed at medical depths, strengths, or with prescription products, these services are treated as medical procedures.
- They require formal delegation protocols, appropriate physician or CRNP oversight, documented competency, and adverse-event preparedness (e.g., infection, vascular injury, medication reactions).
(63 P.S. § 422.41; 49 Pa. Code § 16.61; 35 P.S. § 780-101 et seq; 63 P.S. § 211)
The Paperwork Pennsylvania Regulators Expect to See
Entity Documents
- Physician-led clinical entity documentation demonstrating control over diagnosis, treatment, and prescribing
- Management Services Organization (MSO) agreement clearly separating business functions from clinical decision-making
Licenses & Credentials
- Active, unencumbered Pennsylvania MD/DO license for the medical director
- Current Pennsylvania licenses for CRNPs, PAs, RNs, and LPNs, as applicable
- DEA registration for any clinician prescribing controlled substances
Collaborative & Supervisory Agreements
- CRNP Collaborative Agreements, properly executed and filed in PALS
- PA Supervising Physician Agreements, kept current and available to the Board upon request
Delegation Memos & Clinical Protocols
- Written procedure lists identifying who may perform injectables, device procedures, and IV therapy
- Competency and training checklists for delegated staff
- Device-specific parameter sheets and emergency response protocols
Quality Assurance (QA) Documentation
- Chart-review logs reflecting required frequency and findings
- QA meeting agendas and minutes
- Incident reports with documented remediation
- Device maintenance and safety logs
Marketing & Advertising Review
- Evidence that clinical claims and service descriptions were reviewed or approved by the medical director
- Documentation showing professional titles and advertising claims accurately reflect licensure and supervision
Practical Tips That Survive Audits in Pennsylvania
- Keep CRNP collaborative agreements and PA supervising agreements current, and update them immediately when staff roles, services, or prescriptive authority change. Delays are commonly cited in Board investigations.
- Maintain a centralized compliance binder (digital or physical) containing chart-review logs, QA meeting minutes, competency checklists, and treatment records to demonstrate active supervision.
- Ensure injectable and device protocols include clear adverse-event response algorithms, emergency medications, and escalation pathways, reflecting adequate preparation and oversight.
- Use accurate professional titles and service descriptions in all marketing materials. Pennsylvania Boards closely scrutinize misleading representations and implied unlicensed or unsupervised practice.
Common Pennsylvania Pitfalls (and How to Avoid Them)
- Assuming RNs, LPNs, or estheticians may perform medical procedures independently, rather than only pursuant to physician or CRNP orders, written protocols, and supervision.
- Failing to execute, file, or timely update CRNP collaborative agreements or PA supervising agreements when staff roles, services, or locations change.
- Delegating laser, IPL, or other energy-based device procedures to staff without documented training, competency validation, and physician-approved protocols.
- Stating a chart-review or quality-assurance cadence in agreements or policies but failing to maintain written documentation to prove it occurred.
- Using marketing language that implies unlicensed practice, unsupervised care, or physician oversight that is inconsistent with actual clinical control.
FAQs
Can a nonphysician own my medspa?
Yes. A nonphysician may own the business entity, but may not control medical decision-making, clinical policies, prescribing, or supervision, which must remain with a Pennsylvania-licensed physician.
Do CRNPs and PAs always need a written agreement?
Yes. CRNPs must practice under a written collaborative agreement filed in PALS, and PAs must have a written supervising physician agreement describing scope, supervision, and prescribing authority.
Are estheticians allowed to perform microneedling or laser procedures?
Not when performed at medical depths or power levels. These services are treated as medical acts and require licensed clinicians, written protocols, and physician or CRNP oversight.
Do agreements need to list every drug or device?
No. Agreements must describe the categories of drugs and devices authorized, along with prescribing conditions, consultation requirements, and quality-assurance processes.
Is telemedicine allowed for medical aesthetics?
Yes. Telemedicine is permitted if a valid practitioner–patient relationship is established and the standard of care equivalent to in-person care is met.
Building a Defensible Medspa Structure in Pennsylvania
Many nonphysician-owned medspas in Pennsylvania use a dual-entity structure:
- A physician-led clinical entity responsible for diagnosis, treatment, prescribing, supervision, and medical records
- A management services organization (MSO) responsible for nonclinical operations such as marketing, staffing, billing, and administrative support
- Physician control over all clinical decision-making must be preserved; MSOs may not direct medical judgment or clinical policies
Implementation Plan (30/60/90 Days)
Days 1–30: Foundation & Paperwork
- Inventory all clinician licenses, DEA registrations (if applicable), and current collaboration/supervisory agreements.
- File or update CRNP Collaborative Agreements in PALS before practice or prescribing.
- Review and update PA Supervisory Agreements to reflect actual scope, supervision, and prescribing authority.
- Build or refresh procedure-specific clinical protocols for injectables, devices, and IV therapy.
Days 31–60: Quality Assurance in Action
- Begin the QA and chart-review cadence specified in agreements and internal policies.
- Document all staff training, competency validation, and any remedial actions taken.
- Conduct a mock inspection using Pennsylvania Board expectations for supervision, delegation, and documentation.
Days 61–90: Risk Hardening & Growth
- Re-train injectors and device operators using documented competency checklists.
- Review marketing materials to ensure accurate licensure, titles, and supervision disclosures.
- Implement a new-modality launch protocol requiring training, updated agreements/protocols, competency validation, and physician approval before go-live.
How Medical Director Co. Fits into Pennsylvania Compliance
Medical Director Co. helps Pennsylvania medspas move beyond surface-level compliance by providing practical, defensible medical oversight aligned with Pennsylvania State Board of Medicine and Board of Nursing enforcement standards. Our support includes:
- Pennsylvania-licensed MDs and DOs with experience in medspa and aesthetic services, including injectables, energy-based devices, IV therapy, and related outpatient care models.
- CRNP collaborative agreements and PA supervising agreements drafted and reviewed to reflect Pennsylvania scope-of-practice rules, prescriptive authority, quality-assurance expectations, and required filing through PALS.
- Sustainable quality-assurance systems, including chart-review cadence guidance, QA meeting templates, documentation workflows, and audit-ready records consistent with Pennsylvania Board expectations.
- Delegation and clinical protocol development for injectables, lasers/IPL, RF and ultrasound devices, microneedling, and IV therapy, with physician oversight, competency validation, and adverse-event preparedness.
- MSO and governance alignment, helping ensure business arrangements do not create unlicensed-practice risk or improper control over medical decision-making under Pennsylvania law.
- Telemedicine compliance guidance for aesthetic and related services, addressing practitioner–patient relationship standards, documentation expectations, and controlled-substance safeguards, including PDMP integration where applicable.
- Ongoing regulatory monitoring, tracking Pennsylvania Board guidance, enforcement trends, and statutory changes so medspa agreements, protocols, and policies stay current before compliance issues arise.
Find a Licensed Pennsylvania Medical Director for Your Clinic Today
Medical Director Co. connects you with experienced, Pennsylvania-licensed physicians who provide real clinical oversight—not just a name on paper.
Areas we serve:
Pennsylvania Resources & References
Pennsylvania Statues: https://codes.findlaw.com/pa/title-63-ps-professions-and-occupations-state-licensed/pa-st-sect-63-422-41/
Pennsylvania Code and Bulletin: https://www.pacodeandbulletin.gov
Pennsylvania Licensing System (PALS): https://www.pals.pa.gov
Pennsylvania Prescription Drug Monitoring Program (PDMP): https://www.pa.gov/agencies/health/healthcare-and-public-health-professionals/pdmp
DEA Diversion Control Division (Controlled Substances): https://www.deadiversion.usdoj.gov
Pennsylvania Unfair Trade Practices & Consumer Protection Law: https://www.attorneygeneral.gov/wp-content/uploads/2018/02/Unfair_Trade_Practices_Consumer_Protection_Law.pdf
Pennsylvania Department of Health (DOH): https://www.health.pa.gov
Bolton M. Harris, J.D., is a seasoned attorney with a formidable background in criminal law and a focus on healthcare law and compliance. As the in-house legal counsel at Medical Director Co., Harris brings a unique blend of prosecutorial experience and regulatory expertise to support healthcare professionals across Texas. Her career spans roles as a prosecutor in multiple counties and now as a trusted advisor on the legal intricacies of medical practice operations.
Education & Early Career
Bolton Harris completed her undergraduate studies at Southern Methodist University (SMU) in 2013. During her time at SMU, she was not only a dedicated student but also a competitive athlete on the university’s women’s swimming team. She went on to earn her Juris Doctor from Texas A&M University School of Law in 2016 and became a member of the Texas Bar that same year. Armed with a strong academic foundation and discipline honed as a student-athlete, Harris embarked on a career in criminal law immediately after law school.
Prosecutorial Experience in Texas
Bolton Harris began her legal career in public service as a criminal prosecutor. She served as an Assistant District Attorney in multiple jurisdictions, where she quickly rose through the ranks and handled a broad spectrum of cases. Some highlights of her prosecutorial career include:
- Assistant District Attorney, Dallas County, Texas: Prosecuted a high volume of criminal cases in one of the state’s busiest DA offices, gaining extensive trial experience in both misdemeanor and felony courts.
- Assistant District Attorney, Ellis County, Texas: Continued to hone her courtroom advocacy skills, known for meticulous case preparation and a tenacious pursuit of justice on behalf of the community.
- Assistant District Attorney, Navarro County, Texas: Broadened her legal expertise by handling diverse criminal matters in a smaller county, working closely with law enforcement and community leaders to uphold the law.
Through these roles, Harris built a reputation for being a tough but fair advocate. She brought numerous cases to trial and developed an in-depth understanding of the criminal justice system. This distinguished prosecutorial background laid a strong foundation for the next phase of her career in the private sector.
Healthcare Law & Compliance at Medical Director Co.
After her tenure as a prosecutor, Harris shifted her focus to healthcare law, applying her legal acumen to the medical field. She recognized that the same attention to detail and tenacity that served her in criminal law could benefit healthcare providers navigating complex regulations. Embracing this new direction, Harris became well-versed in the intricate laws governing medical practices – from licensing requirements to patient safety and privacy standards – and is passionate about helping practitioners stay compliant.
In her current role as the in-house attorney for Medical Director Co., Bolton Harris oversees all legal and compliance matters for the organization and its clients. Medical Director Co. is a nurse-owned firm that connects nurse practitioners (NPs), physician assistants (PAs), and registered nurses with qualified medical directors and collaborating physicians, offering fast placements and comprehensive compliance support for healthcare practices. Harris ensures that each of these partnerships and clinical ventures adheres to all applicable state and federal laws. She is responsible for drafting and reviewing collaborative practice agreements, advising on regulatory requirements, and providing ongoing legal counsel as clients establish and grow their clinics. Drawing on her prosecutorial eye for risk management, Harris proactively identifies potential legal issues and addresses them before they escalate, giving healthcare professionals peace of mind.
Bolton M. Harris’s multifaceted expertise – spanning high-stakes courtroom litigation to detailed healthcare compliance – makes her a formidable legal ally. Whether advocating in front of a jury or guiding a medical practice through regulatory hurdles, she remains committed to the highest standards of the legal profession. Her blend of courtroom-tested skill and healthcare law knowledge ensures that clients of Medical Director Co. receive elite-level counsel and steadfast protection in an ever-evolving legal landscape.
