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?

W. Va. Code §30-5-22 requires pharmacies to register with the Board, and §30-5-4 defines 'pharmacy' to include places outside the state that dispense drugs and provide pharmacist care to West Virginia residents. §30-5-24 separately requires mail-order pharmacies (more than 25% of prescriptions dispensed by mail or delivery, regardless of location) to hold a permit. Legislative rule 15 CSR 6 (effective July 1, 2026) states that a non-resident pharmacy must register 'in the same manner as a mail-order pharmacy' through a mail-order registration. The application must identify owners, the pharmacy manager and the PIC, and include the most current valid home-state inspection report and home-state licensure. Under 15 CSR 6 §8, the PIC or at least one designated pharmacist must hold a West Virginia pharmacist license and act as PIC of the registration. Other requirements include a toll-free counseling line on the label, a resident agent, and West Virginia CSMP reporting.

Under 15 CSR 1 §12 (eff. July 1, 2026), a pharmacy compounding sterile preparations needs a Sterile Pharmaceutical Compounding Permit on top of its pharmacy license, issued after a satisfactory inspection. That section does not say whether it applies to non-resident registrants, so confirm with the Board. The Board opened another round of amendments to 15 CSR 1, 3, 5, 8, 14 and 15 for comment (comments closed July 30, 2026); 15 CSR 6 was not on that list. The Board's application page was last updated in 2018 and may be stale. Board contact: 304-558-0558.

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.

W. Va. Code §30-5-4 and 15 CSR 1 §2.1.9 define compounding as preparation on a practitioner's prescription drug order or under the practitioner/patient/pharmacist relationship, including preparation in anticipation of orders based on regularly observed prescribing patterns. 'Manufacturing' includes preparing commercially available products from bulk compounds for resale by pharmacies or practitioners (15 CSR 1 §2.1.34). A separate general rule, 15 CSR 1 §6.1.1, lets a pharmacy transfer prescription drugs without a prescription to a permittee or practitioner if the transfer is recorded and total transfers stay at or below 5% of the pharmacy's prescription drug sales revenue in any 12 months. A pharmacy that exceeds 5% needs a wholesaler permit. No provision found expressly authorizes or prohibits 503A compounded preparations as office stock, or addresses nonresident pharmacies shipping office stock into the state. The Board of Pharmacy enforces these rules.

The law is silent specifically on compounded office use. A proposed amendment to 15 CSR 5 (wholesale/manufacturer; LRMRC-modified filing Aug. 26, 2026) would exclude from 'wholesale distribution' the sale of minimal quantities by retail pharmacies to practitioners for office use, within the same 5% cap; it is not yet final and does not mention compounded products. The 5% transfer rule does not override FDA's position that 503A compounding requires patient-specific prescriptions. Board contact: 304-558-0558, boardofpharmacy@wv.gov.

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?

W. Va. Code §30-5-4 defines 'manufacturer' to cover persons manufacturing, preparing or packaging prescription drugs 'whether within or outside this state', and §30-5-25 requires a Board permit to manufacture, package or prepare drugs. The Board's Non-Resident Manufacturer page defines a manufacturer to include compounding. Board guidance states that an out-of-state manufacturer that distributes its product into West Virginia, directly or through a 3PL, must be licensed as a manufacturer. Wholesale distribution to anyone other than a patient also requires a Board license under the Wholesale Drug Distribution Licensing Act (W. Va. Code §60A-8-7). A pending amendment to 15 CSR 5 (LRMRC-modified filing Aug. 26, 2026) defines 'outsourcing facility' as a 503B-registered facility 'engaged in manufacturing by compounding'. It would treat outsourcing facilities as manufacturers for licensing and require an initial inspection satisfactory to the Board.

The Board has no separate 'outsourcing facility' license. The Non-Resident Manufacturer license (and a Controlled Substances handling permit if applicable) is the credential its materials point to, but confirm the exact category with the Board before shipping. The current 15 CSR 5 (eff. June 11, 2021) on the Secretary of State site is a scanned image and could not be text-searched for outsourcing provisions. The proposed 15 CSR 5 amendments go to the 2027 Legislature for authorization and are not yet in effect. The Board's application pages were last updated in 2018.

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; West Virginia 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.

W. Va. Code 60A-3-302 requires annual registration for anyone who dispenses controlled substances, with a separate registration at each principal place of business, and 60A-3-301 assigns practitioner registration to the board that licenses the practitioner. The WV Board of Medicine's application (July 2026) says licensees must register as a controlled substance dispensing practitioner at each office location where they dispense or administer controlled substances in an office-based setting, but not for inpatient hospital practice or for writing prescriptions filled by a pharmacy. The registration requires a valid DEA number and CSMP access, renews with the license, and costs $15 or $30 per location depending on renewal year. The Board of Pharmacy separately issues an annual in-state controlled substance permit to persons who dispense unless exempted by its Rule 15-2-3.2 (exemptions not reviewed).

The Board of Medicine form covers MDs, podiatrists and PAs only; whether the Board of Osteopathic Medicine (DOs) and Board of Nursing (APRNs) impose an equivalent office-dispensing registration was not checked. Per the WV Board of Pharmacy FAQ, since 1/1/2023 APRNs and PAs may prescribe no Schedule I and at most a 3-day supply of a Schedule II narcotic. Board of Pharmacy permit page last updated 2018-09-07 (older than 2 years).

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.

W. Va. Code Sec. 60A-9-5a(b) requires prescribers and dispensers licensed by the Boards of Medicine, Registered Professional Nurses, Dental Examiners, Osteopathic Medicine, Optometry and Pharmacy, upon initially prescribing or dispensing any Schedule II controlled substance, any opioid or any benzodiazepine to a patient who is not terminally ill, and at least annually thereafter while continuing to treat the patient with a controlled substance, to access the CSMP database and document it. Sec. 16-54-4(f) also requires accessing the database before an initial Schedule II opioid prescription and before extending Schedule II opioids beyond 30 days. All practitioners who prescribe or dispense Schedule II-V drugs must register with the CSMP (Sec. 60A-9-5a(a)); licensing boards enforce through their rules (Sec. 60A-9-5a(c)).

Sec. 60A-9-5a last amended 2021 (HB 2262). The Board of Medicine rule 11 CSR 10 is active in a version effective 6/1/2022, and the Secretary of State lists a newer version as 'In Progress' (text not opened) - check for changes. The statute's reference to 'pain-relieving controlled substance' is a leftover definition; the operative trigger is Schedule II, opioids and benzodiazepines.

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.

The West Virginia Board of Medicine requires licensees (MDs, podiatrists, PAs) to register as a controlled substance dispensing practitioner at each office where they dispense or administer controlled substances, under W. Va. Code 60A-3-301 and 60A-3-302; the registration requires a DEA number and CSMP access and renews with the license (5 or 0 per location). A vendor summary also reports a Board of Medicine dispensing-physician registration (5 for two years), dispensing only to patients as part of an office visit, a posted notice of the right to use a pharmacy, and a 72-hour limit on dispensed controlled substances; those points were not confirmed in rule text.

Controlled-substance office registration confirmed from the Board of Medicine form (read in the state_csr research); the 72-hour cap and sign requirement come from a vendor summary. DOs are licensed by the separate Board of Osteopathic Medicine.

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 physician practicing telemedicine must hold a West Virginia license or an interstate telehealth registration with the Board, and a registrant may not practice from a physical location in West Virginia (W. Va. Code 30-3-13a(b), 30-1-26). (2) A relationship may be established by real-time video, interactive audio with store-and-forward, or real-time audio-only (video preferred), but not by email, text or questionnaire; the telehealth standard of care under 30-1-26 requires an established patient to see an in-person practitioner within 12 months of the initial telemedicine service or lose telemedicine access until an in-person visit (practitioner may suspend case by case; exceptions for acute inpatient, post-operative, behavioral, addiction and palliative care). (3) Physicians practicing solely by telemedicine may not prescribe Schedule II controlled substances, or Schedule II pain drugs for chronic nonmalignant pain, unless the patient is an established patient of the physician or group (other narrow exceptions); Schedule III drugs such as testosterone are not in that ban but fall under the 12-month in-person standard. (4) IMLC: member.

The code site's bill history for 30-3-13a lists 2026 Regular Session SB 677, but it is not listed among signed bills for the section (last signed change: 2024 SB 714). Board of Medicine interstate telehealth registration rule: 11 CSR 15 (per CCHP). The 12-month in-person standard is phrased in 30-1-26 as required content of board telehealth rules.

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 West Virginia RN Board's law-and-scope page (checked 2026-09-23) lists general scope and delegation guidance (the 'Purple Book') but no cosmetic-injection statement, and the Board of Medicine's position statements cover corporate practice, APRN collaboration, lasers and retail IV therapy but not injectables.

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 Joint Advisory Opinion Regarding Retail IV Therapy (listed as 07/27/2026) covers brick-and-mortar and mobile IV clinics and 'IV parties'. A provider-patient relationship must be established first; physicians, and PAs and APRNs within their scope, may assess patients, which requires personally evaluating, diagnosing and recommending treatment, in person or via telehealth with audio/video. IV saline and additives are prescription drugs; the order must be part of a plan including a personal examination, and physicians, PAs and APRNs should not issue standing orders for a retail IV business. RNs may insert IVs and monitor patients without a physician, PA or APRN on site, but may not compound; adding vitamins or drugs to saline is compounding governed by USP <797>, to be done by pharmacists or, in some cases, qualified practitioners who should personally compound what they order.

Date taken from the Board's position-statement listing. The WV RN Board is not a signatory, though the opinion addresses RN roles.

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 West Virginia as strict, citing W.Va. Code §30-3-14 and a Board of Medicine position statement dated 2018-03-19; the Board's position-statement page lists 'Corporate Practice of Medicine 3/19/2018' (a scanned document that could not be read as text). The Board also runs business-entity registration for medical corporations and professional LLCs.

The 2018 position statement is a scanned image; its text was not read.

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 of Medicine's position-statement page lists 'The Use of Lasers in Surgery' (2010-05-10). The file is an image-only PDF, so who may operate cosmetic lasers under it could not be verified. No West Virginia laser-technician licence was found.

Read the position statement directly (wvbom.wv.gov/download_resource.asp?id=11).

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). West Virginia was not among them, but this research did not confirm its statutes. West Virginia's CLIA state agency is West Virginia Bureau for Public Health, Office of Laboratory Services (DHOLSCLIA@wv.gov, 304-205-8913); it can confirm whether any state license or permit applies, including to out-of-state labs.

West Virginia may run its own in-state lab licensing program; this could not be confirmed from a primary source in this pass, so check with the agency before relying on CLIA alone. ASCLS lists West Virginia 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 West Virginia's rule. West Virginia's lab regulator (CLIA state agency) is West Virginia Bureau for Public Health, Office of Laboratory Services (DHOLSCLIA@wv.gov, 304-205-8913). 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. West Virginia 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?

West Virginia 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.