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?

G.S. 90-85.21A requires any pharmacy operating outside North Carolina that ships, mails or delivers a dispensed legend drug into the state to register annually with the Board. It must certify that it employs a pharmacist responsible for dispensing into North Carolina who meets licensure requirements equivalent to North Carolina's, keep a valid home-state license, and dispense only drugs lawfully dispensed by a licensed pharmacist in its home state. The Board's permits page says the pharmacist-manager on the home-state permit serves as the PM for North Carolina and does not need a North Carolina license. Applicants must submit an operational inspection by the home-state board or the NABP Verified Pharmacy Program completed within 12 months before applying. If the pharmacy compounds, the inspection must show compliance with USP compounding chapters, and any deficiencies need documented corrective action.

The statute was last amended in 2005 (S.L. 2005-402), but the Board applies the current 12-month inspection requirement through its permits page, which shows no date and was accessed 2026-09-23. The statute caps fees at $500 for original registration and $200 for renewal. North Carolina rules (21 NCAC 46) could not be fetched from the OAH server (connection reset); the requirements above come from the statute and the Board page.

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.

21 NCAC 46 .2801(c) says: 'A pharmacy may supply compounded drug products to practitioners authorized by law to prescribe drugs for those practitioners to administer to those practitioners' patients. Such compounding for office use shall comply with applicable federal law.' Under .2801(b), compounded preparations may not be offered to other entities for resale. Under .2801(a), dispensing to patients requires a valid patient-specific prescription, with compounding ahead of orders allowed only based on an established prescription history. The state rule sets no quantity cap. Because FDA reads section 503A as requiring patient-specific prescriptions, the federal-law condition in practice limits office stock from 503A pharmacies. The rule does not say whether nonresident registrants may ship office-use stock into North Carolina.

Rule .2801 was last amended effective 8/1/2021 (NC Register 36:05), which is older than 2 years; the Board's March 2026 new-licensee guide still cites .2801 without noting changes. The Board's FAQ says compounding is governed by the federal DQSA and USP chapters. It also says DQSA covers human, not veterinary, drugs, implying the federal limits apply to human office-use compounding. Official OAH rule PDFs could not be fetched (connection reset), so the rule text was read on LII.

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?

G.S. 106-140.1 requires 'every person doing business in North Carolina and operating as a wholesaler, manufacturer, outsourcing facility, or repackager' to register each year with the Commissioner of Agriculture. It defines an outsourcing facility as a sterile-compounding facility registered with FDA under 21 U.S.C. §353b, and the annual fee is $1,000. The NCDA&CS Food and Drug Protection Division's 2026 drug application lists an 'Outsourcing Facility (Sterile 503B)' license type and covers facilities located outside North Carolina, which must attach home-state license verification. Its Form D asks for proof of current FDA outsourcing-facility registration, the most recent federal or state inspection report with any FDA Form 483 or warning letter and responses, and proof of a pharmacy license if applicable. Registrations expire in December each year.

The North Carolina Board of Pharmacy's statute compilation (updated June 2024) has no outsourcing-facility license. The statute's 'doing business in North Carolina' wording plus the application's 'OUTSIDE NORTH CAROLINA' option indicate that out-of-state 503Bs register. If a 503B dispenses patient-specific prescriptions into North Carolina, whether it also needs Board of Pharmacy nonresident registration (G.S. 90-85.21A) was not confirmed; ask the Board. Controlled substances also require NC DHHS registration.

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 Carolina 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.

G.S. 90-101(a) requires anyone who manufactures, distributes, dispenses or conducts research with controlled substances to register annually with NC DHHS (Drug Control Unit), but its fee categories cover clinics, hospitals, nursing homes, researchers, distributors and similar entities rather than individual practitioners. 10A NCAC 26E .0110(a) waives registration for physicians, dentists, podiatrists, pharmacists, optometrists and veterinarians practicing as individual practitioners and licensed in North Carolina. NC DHHS does register 'clinics' (annual fee $125 under the 26E rules) and has a separate registration category for office-based opioid treatment.

The .0110 waiver names physicians but not NPs or PAs; the statute has no individual-practitioner category, and we did not find an NC DHHS registration pathway for individual NPs/PAs - confirm with the NC Drug Control Unit. Whether a group practice that stocks CS must register as a 'clinic' was not confirmed (the rules we read do not define 'clinic'). Rule .0110 was last reviewed 2016-02-02 (older than 2 years) but the statute is current.

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.

G.S. 90-113.74C(a) requires a practitioner, before initially prescribing a targeted controlled substance, to review the patient's prior 12 months in the CSRS and to re-review every three months while the drug remains part of care, documenting each review. 'Targeted controlled substance' means any controlled substance in G.S. 90-90(1) or (2) (Schedule II opium/opiates and opioids) or G.S. 90-91(d) (Schedule III narcotic preparations); anabolic steroids such as testosterone are in G.S. 90-91(k) and are not included. Review is optional when the drug is administered in a health care setting, hospital, nursing home, outpatient dialysis or residential care facility, or is prescribed for cancer or to hospice/palliative patients. The NC DHHS audits compliance and reports violations to licensing boards.

Enacted by the STOP Act (S.L. 2017-74), amended S.L. 2018-76. Dispensers (G.S. 90-113.74D) must review only in listed red-flag situations. Testosterone is Schedule III under G.S. 90-91(k) (anabolic steroids), outside the targeted list.

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.

G.S. 90-85.21(b) requires each physician who dispenses prescription drugs for a fee or other charge to register annually with the North Carolina Board of Pharmacy (on the statutory form) and with the physician's licensing board. Dispensing must comply with the laws that govern pharmacists' distribution of drugs, including packaging, labeling and recordkeeping; the medical board disciplines non-compliance. A vendor summary reports a $75 fee and that PAs and NPs need their own dispensing permits.

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) The Medical Board deems practice to occur where the patient is, so telemedicine providers must be licensed in North Carolina; exceptions include irregular provider-to-provider consultation (G.S. 90-18(c)(11)) and episodic follow-up for an established patient who is temporarily in North Carolina. (2) No in-person exam is required if the technology is sufficient to diagnose and treat within the standard of care; questionnaire-only prescribing is not acceptable. (3) The Board's position statement expects safe prescribing and monitoring of controlled substances, warns that exclusively-telemedicine encounters may be unsuitable in some cases such as pain treatment, and expects participation in the Controlled Substances Reporting System; no statute or rule limiting telehealth prescribing of Schedule III drugs was found. (4) IMLC: member (issuing licenses since 1/1/2026).

Position statement last amended March 2024 (day not shown; source date recorded as 2024-03-01) and still posted as current on 2026-09-23. North Carolina began issuing IMLC licenses 1/1/2026 per the IMLC map. G.S. 90-18 makes unlicensed practice by an out-of-state practitioner a Class I felony (per CCHP quote).

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 NC Board of Nursing's position statement on cosmetic/aesthetic dermatological procedures (covering neuromodulator and dermal filler injections, lasers, light treatments and more) says these are within RN and LPN scope when ordered by a physician, NP, PA or other prescriber. The prescriber must complete a client evaluation/assessment for procedure appropriateness and issue a prescription/order; the nurse must have documented competency; and the employer's procedure and emergency policies must be on site. RNs do not need a prescriber on site; LPNs need on-site presence and supervision by an RN or prescriber. Nurses may not treat walk-in clients without such an order unless separately licensed under the Electrolysis or Cosmetic Art Acts for those activities.

Last revised 9/2022 (month only; recorded as 2022-09-01), posted Feb 2024 — older than two years, possibly stale, but it is the version the Board currently posts.

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 NC Board of Nursing's position statement on IV hydration, nutrient therapies and medications for wellness (covering walk-in and mobile hydration clinics and drip bars) says RNs and LPNs may administer these on a valid order. The nurse must have an individualized prescription/order and a completed client evaluation/assessment before administering; where clients walk in, the nurse must ensure such an individual order exists first. Standing orders are allowed only as signed, written provider instructions for specified situations, not client-driven choices, and nurses may not diagnose. LPNs need supervision; APRNs must document an initial evaluation, diagnosis and treatment plan.

Origin 9/2022; file posted March 2024. Possibly stale (over two years old). NC Division of Health Service Regulation home care licensure may apply to mobile/in-home services (referenced but not reviewed).

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?

The NC Medical Board's position statement on the corporate practice of medicine (amended September 2025) says businesses practising medicine in North Carolina must be owned in their entirety by persons holding active NC licences, or combinations allowed by G.S. 55B-14. Exceptions include nonprofit hospitals and hospital-owned practices, HMOs, public health clinics and charitable nonprofits. Licensees who aid violations face discipline, and the Board may seek injunctions against non-licensed owners. Med spas offering medical services therefore generally use licensee-owned professional entities, often with a management company.

Amended September 2025 (day not given). SB 570 (CPOM/MSO codification) was reported pending in 2025–2026.

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 NC Medical Board's Laser Surgery position statement says laser surgery should be done only by a physician, or by a licensed professional within their scope with appropriate training under physician supervision, preferably on site. Laser hair removal may be performed by physicians, adequately trained individuals designated by a supervising physician, or licensed electrologists designated as laser hair practitioners; tattoo removal only by physicians or physician-designated individuals under the physician's full responsibility. The supervising physician must be on site or readily available, and each patient must be examined by a physician, PA or NP before the first laser hair or tattoo removal treatment. The NC Board of Nursing also lists lasers among cosmetic procedures RNs may perform on a prescriber's order.

Amended May 2021 (day not given) — over two years old, possibly stale, but still posted as current by the Board.

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 Carolina was not among them, but this research did not confirm its statutes. North Carolina's CLIA state agency is North Carolina DHHS, Division of Health Service Regulation/CLIA Certification (DHSR.CLIA@dhhs.nc.gov, 919-855-4620); 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 North Carolina's rule. North Carolina's lab regulator (CLIA state agency) is North Carolina DHHS, Division of Health Service Regulation/CLIA Certification (DHSR.CLIA@dhhs.nc.gov, 919-855-4620). 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)?

Part 2 of Article 23A (S.L. 2019-70, HB 934) covers 'investigational adult stem cell treatments' that are under investigation in an FDA IND/IDE clinical trial and not yet FDA-approved. The treatment must be administered directly by an IRB-certified physician, overseen by an IRB affiliated with an accredited North Carolina medical school, and given at that school, an affiliate, or another IRB-approved facility. Detailed written informed consent is required, and the IRB reports annually to the NC Medical Board. Buying or selling adult stem cells for these treatments is a Class A1 misdemeanor, with exceptions for normal professional fees and IRB-approved research. Part 3 (S.L. 2024-36) separately covers individualized investigational treatments based on a patient's genetic profile. 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.

Outside this narrow pathway, general FDA rules govern. The statute does not address allogeneic birth-tissue products or exosomes.

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 Carolina 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.