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?

Rule 1140-01-.08(3) bars any out-of-state pharmacy practice site from conducting business in Tennessee until it obtains a Board license. The pharmacy must hold its home-state license and file its latest home-state inspection report. A pharmacy that compounds must file an inspection from the past 12 months, and an FDA or NABP inspection is accepted instead of the state one. It must also name a pharmacist in charge who holds a current Tennessee license, keep Tennessee prescription records readily retrievable, and run a toll-free pharmacist line at least 6 days and 40 hours a week. T.C.A. §63-10-216(a) repeats the 12-month inspection rule for out-of-state compounding pharmacies at first licensure and renewal. Separately, any licensee that dispenses or distributes sterile products into Tennessee needs a sterile compounding modifier registration (Rule 1140-01-.12(1)).

Rule text is as amended effective 3/14/2024. The Board's application instructions (Rev. 2/17) are older than 2 years and possibly stale: the $300 registration and $250 sterile-modifier fees may have changed. Those instructions also require a home-state license copy and a DEA certificate if applicable, and for a sterile-modifier applicant the home-state inspection must be from the last 12 months. The official Tennessee rules PDF (publications.tnsosfiles.com) blocked automated fetching, so the LII copy was used. Tennessee's 2026 FAIR Rx Act (SB2040/HB1959) restricts PBM or insurer ownership of pharmacies, with most provisions effective July 1, 2028. That comes from a Bass, Berry & Sims recap only; the statute text was not verified.

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.

Tenn. Code Ann. §63-10-204(6)(D) defines 'compounding' to include preparing a drug 'for use in a licensed prescribing practitioner's office for administration to the prescribing practitioner's patient or patients when the product is not commercially available upon receipt of an order from the prescriber.' Parallel clauses cover health care facilities (E) and EMS (F). So office stock is limited to in-office administration to that prescriber's own patients, not dispensing or resale, and only when no commercial product is available. The Board rules reviewed set no specific quantity cap, office-use label or invoice rule. The statute does not treat resident and nonresident pharmacies differently, but an out-of-state pharmacy still needs its Tennessee license. FDA's position is that 503A compounding must be patient-specific, so a 503A pharmacy supplying office stock may conflict with federal law even though Tennessee's definition allows it.

The FindLaw statute copy is current only through 1/2/2024. The official Justia/LexisNexis copies blocked fetching, so later amendments could not be ruled out. The office-use clause was added by 2013 Pub. Ch. 266 and was cited then as §63-10-204(4); it is now numbered (6), and subdivision numbers have shifted. The 2013 blog source is stale background only. No 2025–2026 Tennessee bill or Board rule changing office-use compounding was found.

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?

Rule 1140-01-.08(3) bars any out-of-state outsourcing facility from conducting business in Tennessee until it holds a Board license. It must file its most recent state or FDA inspection report, send later reports, and follow Chapter 1140-09. Rule 1140-01-.08(5) requires an outsourcing facility that makes sterile products by aseptic processing to register for a sterile manufacturer modifier. Rule 1140-01-.12(1) requires a sterile compounding modifier registration to distribute sterile products into Tennessee. The Board's outsourcing-facility instructions list: proof of FDA outsourcing facility registration and the most current FDA inspection (Rule 1140-09-.02(2)), a home-state license, a criminal background check for the owner or manager, a DEA certificate, and a survey. Nonresident applications get a final review without a Board inspection. Tennessee defines an outsourcing facility as an FDA-registered sterile compounder (T.C.A. §63-10-204).

The instructions show a $525 registration fee, a $10 state regulatory fee, $40 for controlled substances and $250 for the sterile modifier. The form is undated, so fees may have changed. The 1140-09 rule text was relied on as quoted in the Board's instructions; the rule itself was not fetched. No Tennessee rule found says whether an outsourcing facility also needs a nonresident pharmacy license to fill patient-specific prescriptions; confirm with the Board. Representatives who distribute controlled substances in Tennessee need a Board controlled substance registration (Rule 1140-01-.08(4)). Stale-source flag: the controlling text is dated 2024-03-14 (more than 2 years before 2026-09-23); it is the latest version found, but confirm with the board that it is still current.

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; Tennessee 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.

Tenn. Code 53-11-302 (per the FindLaw copy, current as of 2024-01-02) requires anyone who dispenses controlled substances to obtain an annual registration from the Board of Pharmacy and the appropriate professional licensing board, with a separate registration at each principal place of business or professional practice, and 53-11-303(c) says practitioners must be registered to dispense Schedule II-V substances. However, the Board of Medical Examiners' rules (Rule 0880-02-.14, revised November 2025) require physicians who dispense for remuneration to follow federal DEA rules (21 CFR 1304-1308) and keep a separate CS dispensing log, without mentioning any state CS registration, and the Board of Pharmacy's rule chapters contain no practitioner CS registration. It could not be confirmed whether the professional license itself serves as the 'registration'.

Tennessee's code is not freely published by the state, so statute text came from a FindLaw copy (current as of 2024-01-02; older than 2 years - possibly stale). Check with the Tennessee Board of Pharmacy (Pharmacy.Health@tn.gov, 615-253-1299 per the Secretary of State rules page) or the Board of Medical Examiners.

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.

Per the Tennessee Department of Health, practitioners must check the CSMD before prescribing an opioid, benzodiazepine or Schedule II amphetamine at the start of a new episode of treatment, before each new prescription for the first 90 days, and every 6 months thereafter. Practitioners who dispense those drugs must check the first time at that practice site and every 6 months. Checks are not required for hospice patients, non-refillable supplies of 3 days or less, or drugs administered during inpatient or residential treatment in a licensed hospital or nursing home. For other Schedule II-V drugs identified as having abuse potential, a check is required only when the practitioner is aware or reasonably certain the person seeks the drug for fraudulent, illegal or medically inappropriate purposes.

Statute text itself (Tenn. Code Ann. Sec. 53-10-310) is on LexisNexis and was not opened; the requirements are taken from the Department of Health's official CSMD page, which paraphrases the statute. 'New episode of treatment' means a controlled substance not prescribed by that practitioner in the prior 6 months, including dosage/frequency changes.

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 any physician authorized to prescribe in Tennessee may dispense during normal practice without a separate license or registration, that the Board of Medical Examiners has policies on dispensing, and that dispensed controlled substances must be reported to the Controlled Substance Monitoring Database. The statute and board rule text were not reviewed.

Primary-source verification was attempted but Tennessee's code is not openly accessible to the research tools; confirm with the Board of Medical Examiners.

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) No one may practice medicine on a patient in Tennessee, in person or remotely, without a Tennessee license; the Board no longer issues telemedicine licenses, and legacy telemedicine licensees are limited to medical interpretation with no prescriptive authority (Rule 0880-02-.16). (2) No in-person exam is required: a Tennessee licensee may establish or maintain the relationship by secure video or store-and-forward (audio-only calls are not 'telemedicine' under the rule), must meet the prescribing prerequisites of Rule 0880-02-.14(7) (appropriate history and physical exam, diagnosis, plan, follow-up), may not prescribe from a questionnaire alone, and patients under 18 need a facilitator present. (3) Tenn. Code 63-1-155 restricts telehealth prescribing of buprenorphine for OUD to providers employed by or contracted with listed treatment entities; no Tennessee-specific telehealth limit on testosterone or other Schedule III drugs was found in the sources reviewed. (4) IMLC: member.

Board rules verified from rule text; Tenn. Code 63-1-155 was read only as quoted by CCHP (the statute sites tried - Justia, FindLaw, TN SOS - blocked automated access). Rule 0880-02-.16 was last amended effective 2016-10-31 and is still the current text. Source older than 2 years - possibly stale. Check with the Board of Medical Examiners (https://www.tn.gov/health/health-program-areas/health-professional-boards/me-board.html) for any newer telehealth controlled-substance guidance.

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?

Since 2016 every 'medical spa' — an entity offering cosmetic medical services, i.e. services using a biologic or synthetic material, chemical, mechanical device or energy that can alter living tissue to improve appearance — must register with the Board of Medical Examiners (or Osteopathic Board). Registration names a medical director or supervising physician (an MD/DO with an active Tennessee licence and active Tennessee practice) who attests to accepting responsibility for the cosmetic medical services, meets certification requirements in T.C.A. §63-1-153, and complies with its signage and advertising rules; operating unregistered is unprofessional conduct for that physician. Physician practices are covered if they advertise as a med spa or more than half their patients receive elective cosmetic services. The fetched rules do not specify whether RNs may inject or what on-site supervision is needed. The Board of Nursing's position statements (August 2026 compilation) add that physicians and licensed nurses may not delegate to certified medical assistants the administration or preparation of medications used for cosmetic procedures (or IV medications).

T.C.A. §63-1-153 itself (certification and supervision details) could not be fetched. No Board of Nursing statement on RN cosmetic injections was found in the August 2026 position-statement compilation; RN practice falls under general scope rules.

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 Medical Examiners' general rules (rev. November 2025) contain no IV-hydration provisions, and Tennessee's medical spa registration covers cosmetic services rather than wellness IVs. The Board of Nursing's August 2026 position-statement compilation addresses LPN roles in peripheral and central IV infusions and bars delegating IV medications to certified medical assistants, but has no statement on IV hydration clinics, prior exams, standing orders or mobile services.

Check with the Tennessee Board of Nursing and Board of Medical Examiners.

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 Tennessee as strict, citing Tenn. Code Ann. §63-6-204 and the Tennessee Prohibition Against Corporate Practice of Medicine Act; MedPath Compliance also lists it as a CPOM state (statute and case law). Board rule 0880-02-.20 governs medical professional corporations and professional LLCs. Separately, every med spa must register under a Tennessee-licensed physician medical director who accepts responsibility for its services.

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?

Board rule 0880-02-.14(10) says any procedure within the practice of medicine performed with a laser is the practice of medicine (with limited statutory exceptions) and anyone performing it must be under the supervision of a licensed physician. Cosmetic services using energy devices are 'cosmetic medical services', so the facility must register as a medical spa under a Tennessee physician medical director. The rule does not specify the supervising physician's physical presence or limit which trained staff may operate the device.

T.C.A. §63-1-153 may add supervision or certification requirements for cosmetic laser services that were not fetched.

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). Tennessee was not among them, but this research did not confirm its statutes. Tennessee's CLIA state agency is Tennessee Health Care Facilities (CLIA.Health@tn.gov, 615-741-7023); it can confirm whether any state license or permit applies, including to out-of-state labs.

Tennessee 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 Tennessee 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 Tennessee's rule. Tennessee's lab regulator (CLIA state agency) is Tennessee Health Care Facilities (CLIA.Health@tn.gov, 615-741-7023). The question matters for take-home and consumer test kits, not for panels a clinician orders.

A commercial 2026 guide (Just Labs) describes Tennessee as low-restriction; not confirmed against state law. 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)?

According to the sponsor's caucus, the law lets physicians provide non-FDA-approved stem cell or regenerative medicine therapies within their scope of practice. Cells and tissues must come from FDA-registered facilities or accredited third parties and may not be derived from an aborted fetus. Ads must disclose non-FDA-approved status and encourage consulting a primary care provider, and written consent is required. Adverse events must be reported to the licensing authority, and for donor (allogeneic) products also to the manufacturer and accrediting body within 30 days. The rulemaking authority took effect on signing and the other provisions on July 1, 2026. 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.

Signed May 19, 2026, per a law-firm review. Secondary reports say the law sets numeric viability thresholds for non-autologous products (about 90% pre-thaw and 80% post-thaw) and carves out autologous therapies; not confirmed against the enacted text. The law expressly covers 'regenerative medicine' beyond stem cells, so it may reach other biologics; confirm scope with the Tennessee Board of Medical Examiners.

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?

Tennessee 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.