Michigan med spa & injectable regulations

⚠️ negligent delegation is its own disciplinary ground, and injury is not required. a violation of general duty consists of negligence or failure to exercise due care, including negligent delegation to or supervision of employees or other individuals, whether or not injury results — or any conduct, practice or condition that impairs, or MAY impair, the ability to safely and skillfully practice.

Mich. Comp. Laws § 333.16221(a) · read at Internet Archive snapshot — evidence of a page, not the current rule

Personal disqualifications are a separate ground, headed by incompetence. a med spa physician who delegates beyond what the delegate can safely do is exposed under both this and the general-duty ground at once.

Mich. Comp. Laws § 333.16221(b)(i) · read at Internet Archive snapshot — evidence of a page, not the current rule

⚠️ practicing without a license is a felony in Michigan. An individual who practices, or holds himself or herself out as practicing, a regulated health profession without a license — or under a suspended, revoked, lapsed, void or fraudulently obtained one, or outside a limited license, or using another person’s license — is guilty of a felony. Holding out is enough; treating a patient is not required.

Mich. Comp. Laws § 333.16294 · read at Internet Archive snapshot — evidence of a page, not the current rule

And the felony section opens by excepting § 16215 — “Except as provided in section 16215”. Work performed under a lawful delegation is not unlicensed practice, so in Michigan the delegation analysis IS the criminal-exposure analysis.

Mich. Comp. Laws § 333.16294 (opening clause) · read at Internet Archive snapshot — evidence of a page, not the current rule

On finding a ground under § 16221 a disciplinary subcommittee SHALL impose one or more sanctions for each violation, from a table the statute sets out ground by ground: probation, limitation, denial, suspension, revocation, permanent revocation, restitution, or fine. For some grounds the table leaves only permanent revocation — the subcommittee has no discretion to go lower.

Mich. Comp. Laws § 333.16226(1) · read at Internet Archive snapshot — evidence of a page, not the current rule

⚠️ and the fine reaches $250,000. A disciplinary subcommittee may impose a fine not exceeding $250,000.00 for a violation of § 16221(a) or (b) — the general-duty and personal-disqualification grounds, which is where negligent delegation sits — and SHALL impose a fine of at least $25,000.00 where such a violation results in the death of one or more patients.

Mich. Comp. Laws § 333.16226(3) · read at Internet Archive snapshot — evidence of a page, not the current rule

Unprofessional conduct is a ground for disciplinary subcommittee action and consists of one or more of the following: misrepresentation to a consumer or patient, or in obtaining or attempting to obtain third party reimbursement, in the course of professional practice; betrayal of a professional confidence; and promotion for personal gain of an unnecessary drug, device, treatment, procedure, or service.

Mich. Comp. Laws § 333.16221(e)(i)–(iii) · read at Internet Archive snapshot — evidence of a page, not the current rule

⚠️ Michigan requires a license to compound at all, and a second authorization on top of it. “To do business in this state, a person that provides compounding services must be licensed as a pharmacy or manufacturer under this part and, if a pharmacy, authorized to provide compounding services under this section and sections 17748a and 17748b.” The same subsection opens by requiring that “a pharmacy, manufacturer, wholesale distributor, or wholesale distributor-broker, whether or not located in this state, must be licensed under this part” — so every link in the chain that distributes a compounded drug into Michigan is licensed here. A pharmacy license alone does not by itself carry compounding authority.

Mich. Comp. Laws § 333.17748(1) · read at Internet Archive snapshot — evidence of a page, not the current rule

⚠️ and an outsourcing facility must hold a Michigan pharmacy license — federal registration is not enough. “To do business in this state, an outsourcing facility must be licensed as a pharmacy under this part. licenses are renewable biennially.” a Michigan practice buying compounded stock from a 503B should be checking a Michigan pharmacy license, not only an FDA registration.

Mich. Comp. Laws § 333.17748(1) · read at Internet Archive snapshot — evidence of a page, not the current rule

Michigan also makes the out-of-state supplier pay to be looked at. Where the department inspects or investigates an applicant for a pharmacy license that will provide compounding services, or a compounding pharmacy, “and the applicant or compounding pharmacy is located outside of this state, the applicant or compounding pharmacy shall reimburse the department for its expenses incurred” in carrying out that inspection. Out-of-state compounders are inspected, and they fund it.

Mich. Comp. Laws § 333.17748(9) · read at Internet Archive snapshot — evidence of a page, not the current rule

Michigan issues no med-spa license and has no facility registration category for one. Article 15 of the Public Health Code licenses health professions — medicine, nursing, and the rest — and the duties attach to the licensee who performs or delegates the act, wherever they do it. A med spa is not licensed as a med spa in Michigan because there is no such license to issue.

Mich. Comp. Laws art. 15 — part index (surveyed in full) · read at Internet Archive snapshot — evidence of a page, not the current rule

💰 Michigan’s fees are in a separate act from its licensing rules, and they are charged per year. The State License Fee Act sets “Fees for a person licensed or seeking licensure as a cosmetologist, manicurist, natural hair culturist, esthetician, electrologist, or instructor or a person licensed or seeking licensure to operate a cosmetology establishment or school of cosmetology”. Under “Application processing fees” a cosmetology establishment is 25.00 and an esthetician 15.00 through September 30, 2027 (falling to 10.00 after). Under “License fees, per year” an establishment is 25.00 and an esthetician 24.00 through the same date (falling to 12.00). ⚠️ note the scheduled step-down — the statute already carries the post-2027 numbers, so a figure quoted today has an expiry date written into it.

Mich. Comp. Laws § 338.2225(a), (c)

Michigan’s reportable event is a change in the business itself, not a clinical one. “a pharmacy, manufacturer, wholesale distributor, or wholesale distributor-broker shall report to the department a change in ownership, management, location, or its PIC or facility manager designated under subsection (2) not later than 30 days after the change occurs.”

Mich. Comp. Laws § 333.17748(4) · read at Internet Archive snapshot — evidence of a page, not the current rule