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?

Occ. Code §560.001(b) bars a pharmacy in another state from shipping, mailing or delivering into Texas a prescription drug dispensed under a prescription, or delivered for office use under Occ. Code ch. 562 subch. D, unless it holds a TSBP license (the board may exempt isolated transactions under §560.004). Class E applicants must show a home-state license, a pharmacist-in-charge affidavit, the ability to produce records within 72 hours, proof of creditworthiness, and a home-state inspection report no more than 2 years old (3 years at renewal). If the home state does not inspect, NABP, another board, an accreditor or a board-approved consultant may inspect (§560.052(c),(f); 22 TAC §291.104). Under 22 TAC §291.103, the Class E pharmacist-in-charge must be licensed in the home state and, since Sept. 1, 2016, in Texas. A nonresident pharmacy that compounds sterile preparations must hold a Class E-S license, which requires a TSBP (or designee) inspection before issuance and within each renewal period, at the pharmacy's expense (§560.052(g)-(h); 22 TAC §291.106).

TSBP's penalty guidelines in the same rules compilation list a $1,000 penalty for operating a Class E or Class E-S pharmacy without a Texas-licensed pharmacist-in-charge.

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.

Occ. Code §562.152 permits a pharmacy to dispense and deliver a reasonable quantity of a compounded drug to a practitioner for office use. §562.151 defines office use as administration by the practitioner in the office or a facility, and 'reasonable quantity' as no more than the practitioner expects to use before the drug expires, reasonable for the practice, and within what the pharmacy can compound to USP standards. The rules for nonsterile (22 TAC §291.131(f)) and sterile (§291.133(f)) products require a written agreement stating the drug may only be administered, not dispensed or resold. They also require order and distribution records kept 2 years with an audit trail, a 'For Institutional or Office Use Only--Not for Resale' label, and recall procedures that include notice to Texas DSHS. §291.133(a)(2) expressly covers Class E-S (nonresident sterile) pharmacies. §560.001(b) requires the out-of-state pharmacy to hold a TSBP license to deliver office-use drugs into Texas. For the sterile rule, copies of commercially available products may be compounded for office use only in a documented shortage or unavailability.

TSBP's Rules FAQ says Texas law allows compounded preparations to be distributed to a practitioner for office use, but 'such action may not be allowed by federal law'. This reflects FDA's view that 503A compounding must be patient-specific. The Board also says a prescription cannot be written or dispensed 'for office use'.

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?

The Texas Pharmacy Act (Occ. Code chs. 551-569) and TSBP rules contain no outsourcing-facility license. Shipping patient-specific prescriptions into Texas requires a Class E or E-S pharmacy license (§560.001(b); 22 TAC §291.106). For distribution to practitioners, Health & Safety Code §431.402 bars wholesale distribution of prescription drugs in Texas without a DSHS wholesale drug distribution license. DSHS rules define 'wholesale distribution' as distribution to anyone other than a consumer or patient, and a 'wholesale distributor' to include a manufacturer (25 TAC §229.421). A 'manufacturer' includes anyone who compounds prescription drugs, except pharmacist compounding under a prescription. No DSHS or TSBP statement specifically addressing out-of-state 503B facilities was found.

Applying the DSHS distributor/manufacturer license to out-of-state 503Bs is inferred from the definitions quoted above; neither agency confirms it in writing. Check with the DSHS Drug Manufacturers & Distributors program (https://www.dshs.texas.gov/drug-manufacturers-distributors) and TSBP (https://www.pharmacy.texas.gov). A text search of Occ. Code chs. 551-569 found no 'outsourcing facility' provisions.

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; Texas 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.

S.B. 195 (84th Legislature, 2015) retitled Health and Safety Code 481.061 'Federal Registration Required', so that a person must be registered with (or exempt from) the DEA rather than holding a state registration, and repealed the state registration provisions (481.063, 481.064, 481.0645, 481.066 and others), effective September 1, 2016. The same act moved the prescription monitoring program from the Department of Public Safety to the Texas State Board of Pharmacy and redefined 'registrant' as a person with a current DEA registration number.

Source older than 2 years - possibly stale: the controlling source is the 2015 enrolled bill (effective 2016-09-01); the current statute site (statutes.capitol.texas.gov) did not load for our tools, so later amendments were not checked. Applies to APRNs and PAs as well (they prescribe under delegation with their own DEA registrations).

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.

Health & Safety Code Sec. 481.0764(a) requires prescribers and dispensers (other than veterinarians) to access the patient's PMP history before prescribing or dispensing opioids, benzodiazepines, barbiturates or carisoprodol; the check applies each time one of those drugs is prescribed. For any other controlled substance, including Schedule III anabolic steroids such as testosterone, Sec. 481.0764(b) makes the check permissive ('may access'). Sec. 481.0765 exempts patients diagnosed with cancer or sickle cell disease or receiving hospice care (if noted in the prescription record) and good-faith attempts when the system is unavailable. Violations are grounds for discipline by the practitioner's licensing agency; the PMP is run by the Texas State Board of Pharmacy.

Statute text read from the official Texas statutes site (tcss.legis.texas.gov resource file behind statutes.capitol.texas.gov). Sec. 481.0764 was last amended by H.B. 3285 (2019), eff. Sept 1, 2019 (per the history note). Board rules (e.g. 22 TAC 170.9 for physicians) implement the same drug 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.

Occupations Code 158.001 lets a physician supply drugs necessary to meet a patient's immediate needs but not operate a retail pharmacy without a pharmacy license; free indigent-program drugs are allowed. Section 158.002 allows free manufacturer samples. Section 158.003 lets physicians in small rural areas (county of 5,000 or less, or town under 2,500, with no pharmacy within 15 miles) keep and dispense dangerous drugs and be reimbursed for cost, after notifying the Texas State Board of Pharmacy and the Texas Medical Board. The rural exception covers dangerous (non-controlled) drugs, not controlled substances such as testosterone.

Statute text read on a mirror verified against statutes.capitol.texas.gov on 2025-05-26 (the official site did not render for the research tools).

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 may not provide telemedicine medical services to patients in Texas without a full Texas medical license, except physicians who held an out-of-state telemedicine license as of Sept. 1, 2022 (22 TAC 175.1). (2) No in-person exam is required: a valid practitioner-patient relationship can be formed through synchronous audio-video, store-and-forward with relevant clinical records, or other audiovisual technology that meets the standard of care, with follow-up guidance and (with consent) a report to the patient's primary care physician within 72 hours (Tex. Occ. Code 111.005). (3) Prescribing for chronic pain via telemedicine requires two-way audio and video unless the patient is an established pain patient receiving an identical prescription who was seen in person or by audio-video within the last 90 days (22 TAC 175.3(b)); no Texas telehealth limit reaches testosterone or other non-pain Schedule III prescribing, and a valid prescription must also comply with Health and Safety Code chapters 481 and 483. (4) IMLC: member.

The Texas Medical Board rewrote its rules effective 2025-01-09; telemedicine rules now sit in 22 TAC chapter 175 (older citations to chapter 174 are superseded). The chronic-pain audio-video rule applies to pain prescribing generally, not to testosterone for hypogonadism. Tex. Occ. Code 111.005(c): no valid relationship for prescribing abortifacients.

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?

Texas Medical Board rules treat "the injection of medication or substances for cosmetic purposes" as a delegable nonsurgical medical cosmetic procedure (22 TAC §169.25). The delegating physician must ensure the person performing it is trained and signs a written protocol; before the procedure a physician, PA or APRN must establish a practitioner-patient relationship and keep records; a physician, PA or APRN must be on site or immediately available for emergency consultation; and someone trained in BLS must be present (§169.26). The physician must approve or write the written orders, including screening criteria and complication/emergency procedures (§169.27), and the facility must post the delegating physician's name and licence number and staff must wear credential name tags (§169.28). These rules replaced former Rule §193.17 on 2025-01-09.

The TMB rule does not itself limit the delegate to licensed nurses; it requires training and a signed protocol. Texas Board of Nursing scope rules also apply to RNs/LVNs.

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?

HB 3749 (2025) added Occupations Code Chapter 172 on elective IV therapy (IV fluids, nutrients or medications given for temporary discomfort or wellness outside a physician's office or licensed facility). A physician may delegate prescribing/ordering only to a PA or APRN under adequate physician supervision, and administration only to a PA, APRN or registered nurse under adequate physician supervision; delegation runs through Chapter 157 prescriptive authority agreements. The TMB delegation rules for devices used to administer drugs (22 TAC §§169.25–169.26) also require a physician, PA or APRN to establish the patient relationship before treatment and to be on site or immediately available for emergencies. Commentators note LVNs can no longer start elective IVs in these settings.

Law firm summaries say a physician may delegate elective-IV prescriptive authority to at most seven PAs/APRNs (FTE). The TMB page has no date (accessed 2026-09-23).

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 Texas Medical Board describes a "general rule against corporate practice of medicine", with statutory exceptions only for specified entities such as Chapter 162 nonprofit health organizations and certain charitable health centers. Permit Health's 50-state guide classifies Texas as strict and actively enforced, citing Tex. Occ. Code §164.051 and case law including Xenon Health v. Baig (5th Cir. 2016). Non-physicians therefore generally cannot own the medical side of a med spa or employ its physicians.

TMB page has no date (accessed 2026-09-23).

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?

Anyone performing non-ablative laser or pulsed-light hair removal outside a hospital or physician-owned practice must hold a TDLR licence: apprentices complete a 40-hour approved course and work under direct supervision, technicians need 100 supervised procedures, and certified professionals may work unsupervised under a consulting physician's protocol. Each facility needs a TDLR registration, a laser safety officer, and a written contract with a consulting MD/DO (an APRN cannot serve) whose practice is within 75 miles. TDLR does not regulate LHR in hospitals or physician-owned practices; there, and for other cosmetic devices, TMB rules treat "the use of a prescription medical device for cosmetic purposes" as a delegable act subject to §169.26 (prior practitioner-patient relationship; physician/PA/APRN on site or immediately available).

TDLR sheet is dated Dec. 2025 (day not given; recorded as 2025-12-01).

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). Texas was not among them, but this research did not confirm its statutes. Texas's CLIA state agency is Texas Health and Human Services, Health Facility Compliance - CLIA (regional contacts, e.g., CLIA.Austin@hhs.texas.gov); 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 Texas's rule. Texas's lab regulator (CLIA state agency) is Texas Health and Human Services, Health Facility Compliance - CLIA (regional contacts, e.g., CLIA.Austin@hhs.texas.gov). The question matters for take-home and consumer test kits, not for panels a clinician orders.

A commercial 2026 guide (Just Labs) groups Texas with partially restrictive states; 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)?

HB 810 (2017) created Health & Safety Code ch. 1003, amended by HB 3148 (2019). The Texas rule (25 TAC §1.461) requires that the treatment be approved and overseen by an institutional review board affiliated with a medical school or a licensed hospital with at least 150 beds. The patient must have a severe chronic disease or terminal illness, documented by the treating physician. This is a narrow Right-to-Try-style pathway, not general permission for clinics to sell stem cell products. 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 rule (adopted 2018) was accessed via LII. Per a 2024 review, HB 3148 (2019) exempted adult stem cells for homologous use from IRB approval and broadened the IRB options. A 2025 bill to expand treatment settings was not confirmed as enacted.

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?

Texas 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.