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?

RCW 18.64.360 makes any pharmacy outside Washington that ships, mails or delivers controlled substances, legend drugs or devices into the state a 'nonresident pharmacy' that must be licensed by the Department of Health (Pharmacy Quality Assurance Commission). At initial licensure and every renewal it must submit an inspection report issued within two years by a Commission-approved inspection program with 'substantially equivalent standards'; Commission Directive D001 (effective Feb. 5, 2026) lists approved programs (e.g., NABP Verified Pharmacy Program, ACHC, Gates Healthcare Associates and about 20 state boards) and says reports from some states (including Texas, Florida, Arizona, Maryland and Mississippi) are accepted only if the pharmacy attests it does not compound, while Alaska inspections are not accepted. WAC 246-945-235 requires a responsible pharmacy manager licensed in the pharmacy's home jurisdiction (a Washington pharmacist license is not required by that rule), plus a toll-free number printed on labels, a Washington agent for service of process, and readily retrievable records of Washington dispensing.

RCW 18.64.360(7) says the license requirement applies to shipments made under a prescription and lets the Commission exempt pharmacies whose Washington dispensing is limited to 'isolated transactions'. The Sept 2026 application requires a non-compounding attestation when the inspection report comes from a program approved only for non-compounders, so compounding pharmacies in those states need an NABP VPP or other approved inspection. There is no separate Washington sterile-compounding license for nonresidents.

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.

RCW 18.64.011(24) treats distributing pharmacy-compounded products to other licensed persons or businesses 'for subsequent resale or distribution' as manufacturing, unless the Commission approves the specific product. It excludes 'the activities of a licensed pharmacy that compounds a product on or in anticipation of an order of a licensed practitioner for use in the course of their professional practice to administer to patients, either personally or under their direct supervision.' WAC 246-945-100 requires USP <795>/<797>/<800>/<825> compliance for preparations made for 'distribution to a licensed practitioner for patient use or administration.' The Commission's compounding-standards page says pharmacies may not offer compounded products for resale except for a practitioner to administer to an individual patient. Washington sets no numeric quantity cap; FDA's view is that 503A protections apply only to patient-specific prescriptions, so this state allowance does not change federal status.

Nonresident pharmacies: RCW 18.64.360(7) ties the nonresident license to shipments made under a prescription, and no Washington text expressly allows or bars a nonresident 503A pharmacy shipping office-use stock into the state. Treat that as unconfirmed and check with the Commission (WSPQAC@doh.wa.gov). The Commission's March 28, 2025 GLP-1 statement warns that compounding essential copies of commercially available drugs (e.g., semaglutide after the shortage ended) may lead to discipline.

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?

WAC 246-945-246(1)(e) lists 'Outsourcing facilities required to be registered with the FDA as an outsourcing facility as defined in 21 U.S.C. Sec. 353b(d)(4)(A) that are located in Washington, or distribute or sell drugs into Washington' among entities that must be licensed as wholesalers by the Pharmacy Quality Assurance Commission before distributing. Out-of-state applicants must provide a site inspection from their home-state regulator, or a Commission-recognized third-party program, done within the last two years (and every two years at renewal), plus a copy of the resident license and a list of other state licenses (WAC 246-945-246(3)). A separate Washington pharmacy license is not required by this rule.

Pending: on May 15, 2026 the Commission filed a CR-101 preproposal (WSR 26-11-028) to amend WAC 246-945-246 and -247 on wholesaler and manufacturer licensing (virtual entities, OTC-only makers, out-of-state inspection problems). The outsourcing facility requirement could be reworded, so watch for a CR-102. The rule itself was last amended effective 7/1/2020, but it was confirmed in the chapter certified 9/9/2026.

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; Washington 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.

RCW 69.50.302(1) requires annual Pharmacy Commission registration for anyone who manufactures, distributes or dispenses controlled substances, but 69.50.302(4) says personal practitioners licensed or registered in Washington under their professional licensing acts are not required to register unless the exemption is denied for a violation (RCW 18.64.022 and 18.64.026). A 'health care entity' (e.g. freestanding surgery center) needs an annual Commission license to purchase and administer controlled substances (RCW 18.64.450), but RCW 18.64.011 excludes an individual practitioner's office or a multipractitioner clinic, regardless of ownership, unless the owner elects licensure.

RCW 69.50.302 last amended by 2024 c 121. The practitioner exemption covers ARNPs and PAs licensed in Washington with CS authority. A licensed health care entity may dispense no more than a 72-hour supply to a patient in most cases (RCW 18.64.450(4)).

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.

Under WAC 246-919-985 (Medical Commission opioid prescribing rules), a physician must query the PMP before prescribing an opioid or a medication listed in WAC 246-919-970 at the first refill or renewal of an opioid for acute pain, at the transition from acute to subacute pain, and at the transition from subacute to chronic pain. For chronic pain, queries are required quarterly, semiannually or annually depending on patient risk, and on aberrant behavior or when giving episodic care to a chronic-opioid patient; if the EMR integrates the PMP, every opioid or listed-medication prescription must be queried. WAC 246-919-850 states these rules govern the prescribing of opioids in the treatment of pain. PDMP TTAC lists similar rules for other professions (not opened).

Source older than 2 years - possibly stale; these are the versions currently published on the official WAC site (accessed 2026-09-23), filed WSR 18-23-061, effective 1/1/2019. Parallel profession rules listed by PDMP TTAC: WAC 246-853 (DO), 246-918 (PA), 246-840 (nursing), 246-817 (dental), 246-922 (podiatry). Registration is required for anyone prescribing Schedule II-V in Washington.

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.

WAC 246-945-015 lets a practitioner authorized to prescribe or administer a legend drug, including a controlled substance, dispense it directly to the ultimate user. Dispensing practitioners must label containers per RCW 69.41.050 and, under the January 22, 2027 version of the rule, meet the accessible-prescription-information rules in WAC 246-945-026 to -029 (for visually impaired, print-disabled and limited-English patients).

Pending: amended WAC 246-945-015 (WSR 25-04-003) takes effect January 22, 2027, adding accessibility requirements.

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) Under the Uniform Telehealth Act, an out-of-state practitioner needs a Washington license or other authorization, including through a multistate compact; without one, only consultation with a responsible Washington practitioner, a specialty assessment or recommendation that does not include treatment, or continuity-of-care follow-up for an established patient temporarily in Washington is allowed. (2) A practitioner-patient relationship may be established through telehealth (not by email, instant message, text or fax), and there is no general in-person exam requirement. (3) Washington applies the same prescribing standards and law as for in-person care and bars boards from setting a different standard for telehealth; no Washington-specific telehealth limit on Schedule III drugs such as testosterone was identified, and federal controlled-substance rules apply. (4) IMLC: member.

Uniform Telehealth Act enacted 2024 (2024 c 212). The absence of a Washington telehealth-specific controlled-substance rule is based on the telehealth statutes and CCHP's Washington page (updated 2026-08-16); general Washington opioid prescribing rules still apply.

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?

Under Washington Medical Commission rule WAC 246-919-606, before a nonsurgical medical cosmetic procedure the physician must take a history, examine the patient, make a diagnosis, recommend treatment, obtain informed consent and prepare a record. The physician may delegate to a PA, RN or LPN with documented training in techniques, cutaneous medicine, indications/contraindications and complication management. For FDA-approved substances the physician need not be on site but must be reachable by phone and able to respond within 30 minutes; for non-FDA-approved substances the physician must be on site for the whole procedure. Delegates may not re-delegate. The Board of Nursing's 2025 advisory opinion confirms RNs perform these procedures under the direction of an authorized practitioner and LPNs only in routine situations under supervision.

WAC 246-919-606 governs MDs; osteopathic physicians have a parallel rule under the osteopathic board (not fetched). ARNPs practise under their own licence.

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 2025 advisory opinion on medical, aesthetic and cosmetic procedures expressly covers IV therapy and settings such as IV hydration bars and mobile clinics. RNs may administer legend drugs and use devices under the direction of an authorized health care practitioner; LPNs only under supervision in routine situations. Nurses cannot diagnose or prescribe, must obtain orders for managing adverse outcomes, and must follow the Board's Infusion Therapy Management, Standing Orders, Verbal Orders and Compounding advisory opinions. No IV-hydration-specific prior-exam rule was found in the fetched documents.

Advisory opinions are not legally binding. The Standing Orders AO (2025) was listed but not separately reviewed. Admixing vitamins into IV bags is subject to pharmacy compounding standards (WAC 246-945-100 is listed in the AO).

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 50-state guide classifies Washington as a moderate, common-law CPOM state, citing RCW 18.71.011, Morelli v. Ehsan (1988) and Washington Imaging Services v. Dept. of Revenue (2011). Physicians may practise through professional service corporations (ch. 18.100 RCW), and the Board of Nursing's 2025 aesthetics opinion lists the Business Corporation Act and Professional Service Corporations Act as rules that apply to med spa business structures. A 2026 bill to codify stricter CPOM/MSO limits (2SSB 5387) reportedly failed.

MedPath classifies Washington as 'Yes' (case law/agency interpretation); Permit Health as 'Moderate (Common Law)'. Statute and case 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?

WAC 246-919-605 lets a trained physician delegate an LLRP (laser, light, radiofrequency, plasma) procedure to a properly trained and licensed professional whose licence allows LLRP use. The physician must first take a history, examine the patient, diagnose, recommend treatment and obtain consent, and must be on the immediate premises during the patient's initial treatment. For later treatments of established patients a trained local backup physician may cover, reachable by phone and able to see the patient within 60 minutes. Delegates need training in device application, cutaneous medicine, indications/contraindications, pre/post care and complications.

Rule is older than two years but was the current codified text when fetched on 2026-09-23. Unlicensed staff are not authorized by the rule.

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

RCW 70.42.020 bars operating a test site without a license, and the Department of Health's MTS program licenses more than 7,000 sites, including physician offices, clinics, hospitals and independent labs. The state license replaces CLIA certification in Washington; CMS tells Washington labs not to submit Form CMS-116. Sites doing only low-risk tests may request a waiver (RCW 70.42.030). The statute does not expressly address labs located outside Washington.

In-state test sites: yes. Out-of-state labs: not addressed in the statute.

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 Washington's rule. Washington's lab regulator (CLIA state agency) is Washington State Dept. of Health, Medical Test Site Program (MTS@doh.wa.gov, 360-236-4661; https://www.doh.wa.gov/mts). The question matters for take-home and consumer test kits, not for panels a clinician orders.

Chapter 70.42 RCW does not say who may order tests; the Department of Health's rules (WAC) were not reviewed. 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)?

RCW 18.130.420 (2018 c 216) requires a notice ('THIS NOTICE MUST BE PROVIDED TO YOU UNDER WASHINGTON LAW...'), at least 8.5 x 11 inches in 40-point type, posted at the office entrance and in patient areas and given to the patient before treatment. A signed consent form must cover FDA approval status, anticipated results, alternatives, and risks and benefits. Advertisements must carry the notice in type no smaller than the largest used (or spoken, in non-print ads). Practitioners with an FDA IND/IDE, or working for FACT-, BMT CTN- or AABB-accredited institutions, are exempt. A violation is unprofessional conduct. 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.

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?

Chapter 70A.560 RCW (2023 c 455) bars manufacturing or selling cosmetics with intentionally added ortho-phthalates, PFAS, formaldehyde, methylene glycol, mercury and mercury compounds, triclosan, and m- or o-phenylenediamine and salts from Jan 1, 2025. It also bars intentionally added lead at 1 ppm or more. Retailers had until Jan 1, 2026 to sell through existing inventory, and restrictions on formaldehyde-releasing chemicals phase in over 2026-2027. Penalties are up to $5,000 for a first violation and $10,000 for repeats. The Department of Ecology also runs assistance programs for small manufacturers and salons.

Morgan Lewis notes the 'intentionally added' definition change takes effect Jan 1, 2027. The specific formaldehyde-releasing chemicals and their exact phase-in dates were not reviewed; check with the Department of Ecology.Federal MoCRA and FDA cosmetic and OTC sunscreen rules apply in every state.