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?

NDCC §43-15-34.1 requires any pharmacy outside North Dakota that ships, mails or delivers a dispensed prescription drug or legend drug into the state to hold a North Dakota Board of Pharmacy permit. The part of its operation that dispenses to North Dakota residents must follow North Dakota law and board rules. The board issues this as a Class G out-of-state pharmacy permit (NDAC 61-02-01-01(4)(g)). Under NDAC 61-02-01-01(2), any pharmacy receiving a permit must name a pharmacist-in-charge who is a North Dakota-licensed pharmacist in good standing. The same rule also lists the permit's other pharmacists, interns and technicians as North Dakota licensees and registrants. North Dakota sterile compounders dispensing to the public hold a Class C permit, but the rules do not create a separate nonresident sterile permit.

The requirement that the PIC be North Dakota-licensed (61-02-01-01(2)) is written for all permitted pharmacies; its application to Class G permits is read from the rule text and was not confirmed in board guidance (the board's online application pages did not show requirements). 61-02-01-01 was last amended 7/1/2011 and the chapter PDF on 1/1/2024. The pharmacist-majority-ownership rule (§43-15-35) is a North Dakota permit requirement; how it applies to out-of-state permittees was not confirmed.

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.

NDAC 61-02-01-03(9) says human drug products may be compounded for North Dakota practitioners to give patients in their office only if a licensed outsourcing facility (NDCC §43-15.3-13) or a resident North Dakota pharmacy prepares them. A North Dakota pharmacy may also get a compounded drug from a licensed outsourcing facility and dispense it to a patient. Sales of compounded products to other pharmacies, veterinarians, clinics or hospitals count as manufacturing and are not allowed. Compounding is otherwise tied to a prescription or medication order, with anticipatory batches limited to 'regularly used amounts' based on prescription history. In-state office use goes beyond FDA's view that 503A compounding must be patient-specific.

61-02-01-03 was last amended effective 1/1/2024. Nonresident 503A pharmacies are left out because office-use compounding is limited to 'a resident North Dakota pharmacy'. The rule states no numeric cap on in-state office stock. Subsection 9(c) (sales to clinics are 'manufacturing') sits awkwardly beside 9(a); confirm the details with the ND Board of Pharmacy. Stale flag: the underlying rule text was last amended before 2024-09-23 (as_of 2024-01-01), so it is possibly stale; no later amendment was found on the official host checked on 2026-09-23.

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?

NDCC §43-15.3-13 lets a facility supply non-patient-specific compounded human drugs without a prescription only if it is FDA-registered as a 503B outsourcing facility and holds a license under the Wholesale Drug Pedigree chapter (43-15.3) with an outsourcing facility classification. It must also name a pharmacist licensed in its state of residence as the responsible person on the license, and meet the chapter's licensing standards. Within 48 hours of a board request, the facility must provide inspection reports, FDA 483 observations and lists of products distributed into the state. It must also follow the 503B labeling and recordkeeping rules. The license fee listed for an outsourcing facility is $200. The North Dakota Board of Pharmacy administers the license.

§43-15.3-13(4) lets an outsourcing facility sell compounded calcium gluconate for hydrofluoric-acid exposure without a North Dakota license. The fee schedule lists 'Outsourcing facility $200'.

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; North Dakota 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.

N.D.C.C. 19-03.1-16 requires every person who dispenses controlled substances in North Dakota to obtain annually a registration from the Board of Pharmacy, with a separate registration at each principal place of business or professional practice, and N.D.C.C. 19-03.1-01 defines 'dispense' to include prescribing and administering; 19-03.1-17(3) says practitioners must be registered to dispense. However, the Board's fee rule (N.D. Admin. Code 61-11-01-01) lists no controlled-substance registration fee, its applications page lists no practitioner CS registration, and the ND Board of Medicine's PDMP onboarding asks prescribers only for NPI, DEA and medical license numbers. Whether the Board currently issues or waives practitioner registrations could not be confirmed.

Statute says yes; agency materials suggest no practitioner registration is actually issued. Check with the ND Board of Pharmacy (https://www.nodakpharmacy.com/). 19-03.1-16(4) lets the Board waive registration by rule, but no such rule was found in the October 2024 law book.

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.

N.D. Admin. Code 50-05-02-01 requires every practitioner who prescribes controlled substances to register with the PDMP; when the practitioner determines reported drugs will be prescribed for more than twelve weeks, the practitioner must request a PDMP report and then at least semiannually, and must also check when documented signs of diversion or abuse appear. The requirement does not apply in controlled settings where drugs are locked and administered (e.g. admitted hospital or hospice patients, long-term care, group homes). NDCC 19-03.5 defines the monitored 'controlled substances' as all scheduled drugs plus gabapentin and directs each prescribing board to adopt use rules; the PDMP is run by the State Board of Pharmacy.

Source older than 2 years - possibly stale (rule effective Jan 1, 2018, amended Oct 1, 2022; still the posted version). The rule uses 'reported drugs' without defining it; the PDMP statute covers all controlled substances plus gabapentin. Short courses (12 weeks or less) of testosterone do not trigger the check. This rule binds Board of Medicine licensees (physicians, PAs); APRNs (NDAC 54-05-03.1-10), dentists and others have their own rules listed by PDMP TTAC that were not opened.

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.

A vendor summary reports that North Dakota requires no dispensing permit, application or fee, that NPs and PAs may also dispense, and that the Board of Pharmacy publishes administrative guidelines for practitioner dispensing. The statute and rule text were not reviewed.

Confirm with the North Dakota State Board of Pharmacy (nodakpharmacy.com).

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.

(1) A practitioner treating a patient located in North Dakota must hold a North Dakota license (NDCC 43-17-02.3); since 1/1/2025 an out-of-state physician may continue care by telehealth without a North Dakota license for a patient first seen in the state where the physician is licensed, for up to one year at a time before another encounter in that state, plus temporary-visit, pre-visit and consultation exemptions (N.D. Admin. Code 50-02-15-03). (2) No in-person exam is required: the initial exam may be done entirely by telemedicine if equivalent to an in-person exam (secure video or store-and-forward with needed peripherals, or with an intervening licensed provider), but a static questionnaire or audio-only conversation does not meet the standard (NDCC 43-17-44). (3) Opioids may be prescribed by telemedicine only as FDA-approved MAT for opioid use disorder; other controlled substances, including Schedule III drugs such as testosterone, may be prescribed after a compliant telemedicine exam with PDMP participation (50-02-15-02). (4) IMLC: member.

Borderline: the 50-02-15-03 continuation-of-care exemption (eff. 1/1/2025) is broader than a one-off follow-up exception but is not a registration or special license, so it was treated like other follow-up exemptions (answer yes). The opioid limit reaches only opioids.

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?

The ND Board of Nursing's practice guidance 'Role of the Nurse in Aesthetic Practices in Retail Settings' (reviewed April 2025, posted January 2026) says the prescriber must establish a relationship through an initial documented history and physical and a client-specific plan before any treatment; a general medical clearance is not enough, and a change in treatment type, location, product or dose requires a new prescriber assessment first. Standing orders are valid only within that prescriber-client relationship. RNs may not select a medication, dose, device or setting, may not independently buy drugs, need accredited aesthetic education with a supervised practicum, and the supervising professional must be able to respond immediately to complications. The guidance does not apply to LPNs.

File name indicates January 2026; the text describes an April 2025 review. Practice guidance does not have the force of law.

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?

The Board of Nursing's guidance on the role of the nurse in retail IV therapy settings (approved 2024-12-13), which covers IV bars and mobile IV services, says prescribers must perform an initial documented history and physical and create a client-specific plan before any IV therapy, with a new assessment before changes in treatment, product or dose. RNs and IV-certified LPNs may administer only on a prescriber's order, may not select fluids, additives or doses, and may not independently buy drugs or equipment. Standing orders are valid only with a prescriber-client relationship, an initial prescriber assessment and an order appropriate for the specific client. Telehealth is acceptable for the prescriber's assessment.

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 North Dakota as strict, citing N.D. Cent. Code §43-17-31, and MedPath Compliance (reviewed 2026-06-20) lists it as a CPOM state based on statute.

Statute text not fetched.

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?

The Board's 2025 aesthetic practice guidance says FDA-approved devices require prescriptive authority to initiate and order, that it is outside RN scope to select a device or device setting, and that treatment follows a prescriber's documented history and physical and client-specific plan, with the supervising professional able to respond immediately to complications. No North Dakota laser-operator licence or medical board laser rule was located, and the rules for non-nurse staff were not confirmed.

Covers RNs/APRNs only. Check with the ND Board of Medicine for delegation to other staff.

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). North Dakota was not among them, but this research did not confirm its statutes. North Dakota's CLIA state agency is North Dakota Dept. of Health, Division of Health Facilities (CLIAlab@nd.gov, 701-328-2352); 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. ASCLS lists North Dakota among the states that license clinical laboratory personnel, which applies to labs located in the state.

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 North Dakota's rule. North Dakota's lab regulator (CLIA state agency) is North Dakota Dept. of Health, Division of Health Facilities (CLIAlab@nd.gov, 701-328-2352). 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. North Dakota 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?

North Dakota 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.