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?

IC 25-26-17-2 defines a nonresident pharmacy as one outside Indiana that dispenses drugs or devices by mail or other delivery to patients in Indiana, and IC 25-26-17-3 requires it to register with the Board. Registration requires proof of a home-state license, the names of pharmacists dispensing to Indiana residents, and the latest home-state inspection report. If the home state has not inspected the pharmacy within 365 days, or the inspection is not equivalent to Indiana's, the pharmacy must submit a Board-approved third-party, healthcare-accreditation or pharmacy-accreditation inspection. Registrants must keep a toll-free pharmacist line (at least 6 days and 40 hours a week) printed on each label, keep Indiana records retrievable, and follow home-state law. A pharmacy filling more than 25% of its volume from internet orders must hold NABP VIPPS or equivalent accreditation (IC 25-26-17-4.5). The statute does not require an Indiana-licensed pharmacist-in-charge.

The PLA page says a nonresident pharmacy must obtain registration before shipping into Indiana; applications need a home-state inspection report, official license verifications, and a sample label showing the toll-free number. 856 IAC 1-27-1 sets fees of $100 for the initial application and $200 for the biennial renewal. New in 2026: IC 16-42-22.5-3(b), added by P.L.136-2026, lets the Board require a nonresident pharmacy that ships drugs compounded from bulk substances into Indiana to document bulk-substance sourcing (FDA-registered manufacturer, certificate of analysis, no research- or veterinary-grade API). The effective date of P.L.136-2026 was not confirmed.

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.

The Board's rules (856 IAC 1) have no office-use compounding provision. IC 25-26-14-11 excludes a retail pharmacy's sales to practitioners for office use from 'wholesale distribution' when they are 'minimal quantities' or no more than 5% of the pharmacy's legend drug sales over 12 months. That exclusion is about drugs in general, not compounded preparations. IC 16-42-22.5-4(a), added by P.L.136-2026, requires a pharmacy subject to section 503A to comply with 503A and its regulations, which FDA reads as requiring patient-specific prescriptions. IC 16-42-22.5-3 also sets bulk-substance sourcing rules for anyone who compounds. Whether an Indiana or nonresident 503A pharmacy may supply compounded office stock was not confirmed.

New in 2026: P.L.136-2026 created IC 16-42-22.5 (compounding definitions, bulk-substance sourcing, a 503A/503B compliance mandate, primary Board investigative authority, and twice-yearly compounding oversight reports). Its effective date was not confirmed. IC 25-22.5-12.5 (medical spas) also requires a medical spa to state whether it engages in compounding. Confirm with the Indiana Board of Pharmacy (pla4@pla.in.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?

No outsourcing-facility license or registration appears in IC 25-26 or in 856 IAC articles 1-5 (searched September 2026), and the PLA's facility licensing page lists no 503B category. IC 25-26-14-14 requires anyone engaged in wholesale distribution of legend drugs to hold an Indiana wholesale drug distributor license and NABP accreditation (Drug Distributor Accreditation, formerly VAWD). The definition of wholesale drug distributor includes manufacturers (IC 25-26-14-12), but distribution by the 'original manufacturer of the finished form' is excluded (IC 25-26-14-11(13)). How a 503B's own compounded products are treated was not confirmed. A 503B that dispenses patient-specific prescriptions to Indiana patients would fall under the nonresident pharmacy definition (IC 25-26-17-2). New IC 16-42-22.5-4(b) (P.L.136-2026) requires facilities subject to section 503B to comply with it.

The lead suggested an Indiana outsourcing facility permit, but none was found in the 2026 Indiana Code or 856 IAC. Web search was unavailable to find Board guidance on 503Bs. Confirm the required credential with the Indiana Board of Pharmacy (pla4@pla.in.gov) before shipping.

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; Indiana 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.

The Professional Licensing Agency states that practitioners must hold a CSR to prescribe, administer, store, dispense or otherwise handle controlled substances in Indiana, and must hold both the CSR and a DEA registration (unless exempt under 856 IAC 2-3-5(b) or 2-3-6). The application and renewal fee is $60; the CSR renews on the same cycle as the practitioner's Indiana professional license, which must be active. Applicants must use an Indiana street practice address - an out-of-state address is rejected - and it should match the DEA registration. A separate CSR is required for each location where the practitioner administers, stores or dispenses controlled substances, unless done under a facility's CSR.

2025 change: the opioid-prescribing CE requirement for CSR issuance/renewal (IC 35-48-3-3.5) expired July 1, 2025. Telehealth caution: the PLA page requires an Indiana practice address for the CSR. Statute text itself was not opened; requirement taken from the agency page.

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.

IC 25-26-24-19(k) requires, since January 1, 2021, all practitioners to obtain the patient's INSPECT information (directly or through an integrated health record) before prescribing an opioid or benzodiazepine; for patients under a pain management contract a check is not required more than once every 90 days. Exceptions: a board waiver for lack of Internet access, inpatient or observation patients, a documented database outage, and hospice enrollees. The Medical Licensing Board rule 844 IAC 5-6-7 separately requires physicians to run an INSPECT report at the outset of an opioid treatment plan and at least annually. INSPECT is run by the Indiana Board of Pharmacy.

Testosterone (C-III) is not caught. Statute text was read on a FindLaw copy (the official iga.in.gov code viewer is script-only); the INSPECT laws page links to the same IC 25-26-24 chapter. PDMP TTAC also lists nursing, dental and other board rules (e.g., 848 IAC 5-4-7) not reviewed.

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 Indiana Professional Licensing Agency states practitioners must hold a CSR to prescribe, administer, store, dispense or otherwise handle controlled substances, with a separate registration for each location where controlled substances are administered, stored or dispensed ($60 initial and renewal). A vendor summary reports no separate license for dispensing non-controlled drugs and next-day reporting of dispensed controlled substances to INSPECT (the PDMP).

General (non-controlled) dispensing rules not confirmed in statute. The CSR opioid CE requirement expired July 1, 2025 per PLA.

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.

Indiana ended its out-of-state telehealth certification in 2024, so providers need an Indiana license. Telehealth care is held to in-person standards (IC 25-1-9.5-7). A controlled substance may be prescribed to a patient the prescriber has not examined in person only if the standard of care is met, the prescriber holds an Indiana controlled substance registration, meets federal DEA requirements, uses a real-time two-way audio-video connection, and complies with INSPECT (IC 25-1-9.5-8). IMLC: member.

CCHP cites an Indiana PLA notice (June 7, 2024) terminating out-of-state telehealth certifications.

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 Indiana State Board of Nursing (Indiana Professional Licensing Agency)'s website was checked on 2026-09-23 for a position statement, advisory opinion or FAQ on cosmetic injectables (neuromodulators, fillers) and none was found. RN practice therefore falls under the state's general nurse practice act, which was not reviewed for this entry.

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 Indiana State Board of Nursing (Indiana Professional Licensing Agency)'s website was checked on 2026-09-23 for guidance on IV hydration clinics (prior exams, standing orders, mobile services) and none was found.

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 rates Indiana 'Moderate', citing Ind. Code §§25-22.5-1-2(c) and 25-22.5-8-1; MedPath Compliance (reviewed 2026-06-20) lists Indiana as 'Yes' and reports HB 1666 (signed 2025-05-06) giving the Attorney General market-oversight authority and ownership-reporting requirements.

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?

No Indiana statute, rule or board policy on delegation of cosmetic laser/IPL procedures or a laser-operator credential was located on 2026-09-23.

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). Indiana was not among them, but this research did not confirm its statutes. Indiana's CLIA state agency is Indiana Dept. of Health, Division of Acute Care Services (IndianaCLIA@health.IN.gov, 317-233-7502); 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 Indiana's rule. Indiana's lab regulator (CLIA state agency) is Indiana Dept. of Health, Division of Acute Care Services (IndianaCLIA@health.IN.gov, 317-233-7502). 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. Indiana 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?

Indiana 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.