FDA and state rules, for what you actually buy.

Must a pharmacy located in another state hold a license/registration from this state to ship prescriptions (including patient-specific 503A compounded preparations) to patients or practitioners here?

MCL 333.17748(1) says a pharmacy, 'whether or not located in this state, must be licensed' to do business in Michigan. MCL 333.17748(2) requires every pharmacy to designate a pharmacist licensed in Michigan as pharmacist in charge (PIC), and LARA's licensing guide confirms this applies to out-of-state applicants. The guide says an out-of-state pharmacy that will not ship sterile compounded products must submit an inspection report from its home-state board or from NABP's Verified Pharmacy Program (VPP), performed within the last 2 years. Pharmacies that ship sterile compounded products into Michigan must submit, at application and at each renewal, a current accreditation certificate or an inspection report from the last 18 months showing USP compliance. The report must come from a Board-approved entity: ACHC, CPS Solutions, Gates Healthcare Associates, the Joint Commission programs, NABP-VPP, the NABP Multistate Pharmacy Inspection Blueprint program, PCAB or The Compliance Team (MCL 333.17748a(1); R 338.532). The license renews every 2 years, and out-of-state applicants reimburse the department's inspection costs. LARA and the Michigan Board of Pharmacy enforce these rules.

MCL 333.17748 was last amended by 2020 PA 142, per the Legislature site. The LARA guide is undated and was accessed 2026-09-23. R 338.532 took effect 2024-02-29. Michigan is unusual in requiring a Michigan-licensed PIC for out-of-state pharmacies. The lead's 'NABP VPP' point is confirmed as one accepted inspection source.

May a 503A (traditional) pharmacy dispense or distribute compounded preparations to a practitioner for office use (administration in the office, not patient-specific)? The federal position is that 503A requires patient-specific prescriptions; this is what the state pharmacy act and board rules allow.

MCL 333.17748b(1) bars a pharmacy from compounding sterile or non-sterile drugs for a prescriber or health facility to administer without a prescription, unless the drug complies with the latest FDA guidance under 21 USC 353a. On application, LARA may authorize a pharmacy to compound 'in limited quantities without a prescription' for a named prescriber or facility. The application must list the drugs, the reason, the expected monthly quantities and USP-consistent operating conditions. It needs a prescriber affidavit that the drugs are only for patients in Michigan or adjacent states. Authorizations last 2 years, and the prescriber may not redispense or sell the product. Topical non-sterile compounding is exempt from this restriction. MCL 333.17748a also bars giving samples or complimentary starter doses to health professionals and offering excess compounded drugs to other pharmacies for resale. MCL 333.17702(5)(b) defines compounding to include preparation on a prescriber's medical order for use in their practice. LARA's public list names only two authorized pharmacies (Northmark Pharmacy and Stokes Pharmacy). The statute does not expressly limit authorization to in-state pharmacies. The default rule matches FDA's patient-specific view of 503A; the authorization route is a state-law exception.

MCL 333.17748b was added by 2014 PA 280, effective 2014-09-30, and was still current on the Legislature site on 2026-09-23. It is not confirmed whether LARA grants 17748b authorizations to nonresident licensees; check with LARA (BPLHelp@michigan.gov). R 338.533 (effective 2024-02-29) adopts the 2023 USP <795>/<797> standards for all Michigan-licensed compounders.

Does the state require an FDA-registered 503B outsourcing facility located outside the state to hold a state license/registration (as an outsourcing facility, nonresident manufacturer, wholesaler or pharmacy) before shipping into the state?

MCL 333.17748(1) says 'to do business in this state, an outsourcing facility must be licensed as a pharmacy.' MCL 333.17748(2) requires a pharmacist in charge licensed in Michigan. Mich. Admin. Code R 338.533(4) says an out-of-state outsourcing facility that distributes compounded drugs in Michigan must be inspected and registered by FDA as an outsourcing facility before it applies. At application and at each renewal, LARA's guide requires an inspection report from the last 18 months showing current good manufacturing practice (21 CFR part 211) compliance. The report must come from FDA or Gates Healthcare Associates, and FDA documentation may include the Form 483, the corrective-action plan and the twice-yearly product report. R 338.533(6)(d) requires labels such as 'This is a compounded drug. For office use only' or 'Not for resale.' LARA and the Michigan Board of Pharmacy enforce these rules.

The lead's 'MCL 333.17748a outsourcing facility license' is not quite right. The license requirement is in MCL 333.17748(1), which says outsourcing facilities are licensed as pharmacies. Section 17748a covers sterile compounding accreditation and says outsourcing facilities must follow FDA requirements. R 338.533 took effect 2024-02-29.

Has the state signed FDA's standard Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products (October 2020)? If not, FD&C Act §503A limits its 503A pharmacies' out-of-state distribution to 5% of total prescription orders (currently not enforced by FDA pending rulemaking).

Signing the standard MOU means the state board agrees to investigate complaints about compounded drugs its 503A pharmacies ship out of state and to identify and report to FDA pharmacies that distribute "inordinate amounts" interstate (more than 50% of their compounded prescriptions); in exchange, the statutory 5% out-of-state cap in FD&C Act §503A(b)(3)(B) does not apply to that state's pharmacies. FDA lists only Colorado, Kentucky and New Hampshire as signatories; Michigan is not among them. For a non-signing state, FD&C Act §503A(b)(3)(B)(ii) caps a 503A pharmacy's out-of-state distribution of compounded drugs at 5% of its total prescription orders. FDA now considers the October 2020 standard MOU suspended (it does not expect signatory states to carry out MOU activities and will not sign new ones) and is not enforcing the 5% limit until a final rule and an updated MOU are published; FDA's rulemaking (RIN 0910-AI71) listed a proposed rule for 11/2026 in the Fall 2025 Unified Agenda.

The FDA list of signed MOUs (current as of 2023-01-23) is older than 2 years, but FDA stopped entering new agreements under the 2020 MOU in October 2022, so no state can have signed since. The FDA "Compounding Information for States" page (current as of 2026-08-28) still describes the MOU as awaiting rulemaking. Pending: FDA proposed rule on 503A distribution (RIN 0910-AI71, NPRM projected 11/2026); H.R. 5316 (introduced 2025-09-11, referred to House Energy & Commerce) would remove the MOU provision from §503A.

Besides DEA registration, does the state require practitioners to hold a separate state controlled substance registration, license or permit to prescribe, administer or dispense controlled substances (e.g. testosterone, Schedule III)? "Conditional" means a state registration is needed only in some settings, such as keeping controlled-substance stock in the office.

MCL 333.7303(1) requires a person who prescribes or dispenses a controlled substance in Michigan to obtain a license from the administrator (Board of Pharmacy/LARA) and to renew it concurrently with, and for the same number of years as, the professional license; subsection (6) requires a separate license at each principal place of professional practice where the licensee prescribes or dispenses. LARA's MD licensing guide says anyone who will prescribe or dispense controlled substances must apply for both the MD license and a controlled substance license; the fee is $259.10 (application plus 3-year license) and renewal is $248.10 every 3 years, with opioid and controlled-substance awareness training required. Separately, a prescriber who dispenses prescription drugs (other than complimentary starter doses) needs a drug control license from the board for each location where drugs are stored and dispensed (MCL 333.17745).

MCL compiled through PA 91 of 2026. Per-location: the statute requires a separate license for each principal place of practice; LARA's administrative rules on multiple prescribing sites were not opened in this session. NPs and PAs with prescriptive authority obtain their own Michigan CS license.

Must a prescriber query the state Prescription Drug Monitoring Program before prescribing, and does the mandate cover Schedule III drugs such as testosterone? "Yes" means a mandate that reaches Schedule III; "conditional" means a mandate limited to certain drugs (e.g. opioids or benzodiazepines) or situations; "no" means no prescriber query mandate.

MCL 333.7303a(4) requires a licensed prescriber, before prescribing or dispensing a controlled substance in a quantity exceeding a 3-day supply, to obtain and review a report on the patient from the state's Schedule 2-5 monitoring system (MAPS); 333.7303a(5) requires MAPS registration before prescribing or dispensing any controlled substance. Exemptions: dispensing in a hospital or freestanding surgical outpatient facility where the drug is administered there, veterinary settings, and hospice patients whose report was reviewed at hospice admission. The duty covers physicians who dispense. Enforced by LARA and the prescriber's licensing board.

Source older than 2 years - possibly stale (last amended 2017 PA 249, eff. 12/27/2017; text confirmed current on the Michigan Legislature site on 2026-09-23). Frequency: every prescription/dispensing above a 3-day supply (no periodic interval). Treated as 'yes' because all schedules 2-5 are covered and the 3-day threshold is a small-supply exemption; typical testosterone prescriptions exceed 3 days. In-office administration is not listed as a trigger.

May physicians dispense prescription drugs (not just administer them) directly to patients from their practice? "Yes" means allowed under standard rules (labeling, records, and at most a simple notice to the board); "conditional" means a separate dispensing registration, permit or license, or quantity, day-supply or drug-category limits; "no" means prohibited except narrow exceptions.

MCL 333.17745 requires a prescriber who wishes to dispense prescription drugs to obtain a drug control license for each location, except for dispensing in a hospital emergency department or trauma center or giving complimentary starter doses. Dispensing is limited to the prescriber's own patients and may be delegated only as the Public Health Code allows. Containers must be labeled (location, patient, date, prescriber, directions, drug, strength, quantity, expiration), and chart records kept at least 5 years.

Last amended by 2016 PA 499, effective April 9, 2017; still current at access. Controlled substances also require a Michigan controlled substance license. Source older than 2 years - possibly stale; the text was confirmed as the current version on the Michigan Legislature site at access.

For a patient located in the state: must the prescriber hold this state's license (or a telehealth registration or special license), is an in-person exam required before prescribing (generally or for controlled substances), are there state limits on prescribing Schedule III drugs such as testosterone by telehealth, and is the state an Interstate Medical Licensure Compact member? "Yes" means a state license and the in-person standard of care apply (opioid-only or Schedule II-only limits are described but do not change the answer); "conditional" means extra state conditions such as a telehealth registration route, an in-person exam requirement, controlled-substance limits reaching Schedule III, or registration of telehealth businesses. Federal DEA rules apply on top.

A health professional may prescribe through telehealth if acting within scope and, for a controlled substance, meeting the Public Health Code's requirements, and must offer referrals and follow-up (MCL 333.16285). A Schedule 2-5 controlled substance may be prescribed only within a bona fide prescriber-patient relationship with follow-up monitoring (MCL 333.7303a). No blanket in-person requirement applies. IMLC: member; a sunset-triggered withdrawal was averted when HB 5455 (PA 6 of 2026) was signed March 26, 2026.

HB 5455 passed both chambers and was approved March 26, 2026 as PA 6 of 2026 with immediate effect, keeping Michigan in the IMLC; the IMLC map still shows Michigan issuing licenses.

Who may administer botulinum toxin and dermal fillers (physicians, PAs, NPs, RNs, LPNs, estheticians, dentists), under what supervision (on-site vs available), and must a physician/NP/PA perform a prior good-faith exam?

Public Health Code §16215 lets a licensee delegate selected acts within their scope to a licensed or unlicensed individual qualified by education, training or experience, performed under the licensee's supervision, but not acts that under prevailing standards require the licensee's own education, skill and judgment. Procedures requiring surgical instrumentation may generally be delegated only to licensed individuals. 'Supervision' (§16109) means continuous availability of direct communication in person or by phone or telecommunication, regularly scheduled review and consultation, and predetermined procedures and drug protocols. No Michigan rule specific to cosmetic injectables was found.

MCL site shows law 'complete through PA 91 of 2026' (accessed 2026-09-23). Whether a given cosmetic injection 'requires the level of education, skill, and judgment' of a physician is a judgment for the delegating physician; LARA guidance on cosmetic injectables was not located.

What does the state require for elective IV hydration/vitamin (incl. NAD+) therapy: who may start IVs, is a patient-specific order or good-faith exam required before a patient's first IV, are standing orders allowed, and are there rules for mobile IV services?

Under MCL 333.16215 a physician may delegate acts within their scope to qualified licensed or unlicensed individuals under supervision, meaning continuous availability of direct communication, regular review, and predetermined procedures and drug protocols (MCL 333.16109). No Michigan Board of Nursing or LARA statement on elective IV hydration, prior exams or mobile IV services was located.

Check with LARA / Michigan Board of Nursing for IV-hydration guidance.

Does the state enforce the corporate practice of medicine doctrine (non-physicians may not own medical practices or employ physicians), and how does that affect med spa ownership?

Permit Health's 2025 guide classifies Michigan as strict, citing Business Corporation Act §251(1) and Attorney General Opinions No. 6592 (1989) and No. 6770 (1993). MedPath Compliance (reviewed 2026-06-20) also lists Michigan as a CPOM state.

Who may perform laser/IPL/RF aesthetic procedures (laser hair removal, resurfacing): physicians only, delegated to RNs/PAs, or licensed electrologists/estheticians/laser technicians with state certification?

MCL 333.16215 permits delegation of acts within the physician's scope to individuals qualified by education, training or experience, under supervision (continuous availability of communication, regular review, predetermined procedures). Procedures requiring 'surgical instrumentation' may generally be delegated only to licensed individuals, which may matter for ablative devices. No Michigan statute or rule creating a laser credential was located.

Whether a laser counts as 'surgical instrumentation' is not defined in the fetched text.

Does the state license clinical laboratories itself, beyond federal CLIA certification, including out-of-state labs that test specimens from the state?

Most states rely on federal CLIA certification alone. The states confirmed in this research as issuing their own lab licenses are California, New York, Pennsylvania, Maryland and Rhode Island (which also reach out-of-state labs testing specimens from their residents), plus Nevada, Washington, Massachusetts, New Jersey and New Hampshire (labs located in the state). Michigan was not among them, but this research did not confirm its statutes. Michigan's CLIA state agency is Michigan LARA, Laboratory Improvement Section (LARA-BSC-CLIA@michigan.gov, 517-241-2648; www.michigan.gov/clia); it can confirm whether any state license or permit applies, including to out-of-state labs.

Absence of a state license was not verified against the state's statutes or rules.

May consumers order their own lab tests without a practitioner order (direct access testing)? A practitioner-ordered panel is always fine; this matters for take-home and consumer test kits.

ADLM (formerly AACC) reported in 2019 that 37 states and DC let consumers order some or all tests directly, but it did not publish the state list, and this research did not confirm Michigan's rule. Michigan's lab regulator (CLIA state agency) is Michigan LARA, Laboratory Improvement Section (LARA-BSC-CLIA@michigan.gov, 517-241-2648; www.michigan.gov/clia). The question matters for take-home and consumer test kits, not for panels a clinician orders.

The ADLM figure dates from 2019 (older than 2 years).

Has the state enacted a law or rule specifically about stem cell, exosome or regenerative-medicine therapies (notice/disclosure duties, permission for certain non-FDA-approved uses, or Right to Try extensions covering them)?

Compilations of state stem-cell laws from 2024 to 2026 list about a dozen states with specific laws (California, Florida, Georgia, Mississippi, Nevada, North Carolina, Tennessee, Texas, Utah, Vermont, Washington and Wyoming), plus Montana's general experimental-treatment law and Kansas's state stem cell center. Michigan is not among them. Without a state-specific law, regenerative products are governed by federal FDA rules plus the state's general medical practice, advertising and consumer-protection laws, enforced by its medical board. Federal FDA rules still apply regardless of state law: stem cell, birth-tissue and exosome products are regulated by FDA, and a state law cannot make an unapproved biologic FDA-approved.

The finding of no law rests on multi-state compilations (a commercial one from Aug 2026 and a peer-reviewed one from Feb 2024, which is older than 2 years) and targeted searches, not a statute-by-statute review, and neither compilation is exhaustive. General Right to Try laws for terminal patients, where they exist, were not reviewed here.

Does the state have cosmetic or sunscreen requirements beyond federal MoCRA, such as ingredient bans (PFAS, formaldehyde, phthalates), ingredient reporting, sunscreen-ingredient bans, or bans on selling animal-tested cosmetics?

Michigan does not appear on 2026 compilations of state PFAS-in-cosmetics laws, on the list of states banning animal-tested cosmetics, or among the jurisdictions with sunscreen-ingredient bans. Federal MoCRA and FDA rules on cosmetics and OTC sunscreens still apply. Other state laws that touch cosmetics generally, such as state food-drug-cosmetic acts or consumer-protection laws, were not surveyed.

The animal-testing list is Wikipedia's 'as of 2023' compilation (older than 2 years); effective dates were not confirmed.