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?

Under SDCL 36-11-19.2 and 36-11-19.3, a pharmacy outside South Dakota that ships, mails or delivers dispensed drugs to South Dakota residents must be licensed by the Board of Pharmacy before doing business in the state. It must be licensed and in good standing in its home state and must identify its pharmacist-in-charge and the pharmacists who serve South Dakota patients. ARSD 20:51:27:02 (amended effective Aug. 16, 2026) also requires disciplinary history, a list of other state licenses, a description of services to South Dakota patients, and an on-site inspection from the last four years by the home-state agency, a Board-recognized accreditation body, or FDA. The Board's FAQ says the nonresident PIC does not need a South Dakota pharmacist license. The pharmacy must also offer counseling through a toll-free number printed on each label and available at least 6 days and 40 hours a week (SDCL 36-11-19.8), and must designate a resident agent (SDCL 36-11-19.9). No separate nonresident sterile-compounding permit was found.

Licenses expire June 30 each year. The fee is $200 for both initial and renewal (ARSD 20:51:27:03), with a $50 late fee. Board application instructions accept an inspection under 4 years old, NABP VAWD/DDA accreditation, or a written explanation. The statutory definition (SDCL 36-11-19.2) joins 'ships...dispensed drug' with providing drug information 'or' counseling South Dakota residents, and SDCL 36-11-2(19) defines 'pharmacy' to include places outside the state that dispense to South Dakota residents. ARSD 20:51:27 was amended by 53 SDR 13, effective Aug. 16, 2026.

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.

SDCL 36-11-2 defines compounding as preparation on a practitioner's prescription drug order or within the pharmacist-patient-practitioner relationship, 'not for sale or dispensing'. The definition also covers preparation in anticipation of orders based on routine, regularly observed prescribing patterns. It defines a 'prescription drug order' as an order for a specific patient. ARSD chapter 20:51:31 adopts USP <795>, <797>, <800> and <825> by reference and has no office-use provision. The wholesale chapter excludes 'minimal quantities' distributed by a licensed retail pharmacy to a licensed practitioner for office use from the DSCSA-style definition of 'transaction' (SDCL 36-11A-1.2(7)). It also treats a pharmacy whose distributions to non-consumers reach at least 5% of gross sales as a 'pharmacy distributor' (SDCL 36-11A-4). Neither provision expressly authorizes 503A compounded office stock.

The statute and rules are silent on compounded office use, and no Board guidance on it was found. The Board's policy statements page lists no office-use statement. Board contact: pharmacyboard@state.sd.us, (605) 773-3361. The compounding rules were rewritten by 50 SDR 138 (eff. June 2, 2024) and amended by 52 SDR 27 (eff. Sept. 15, 2025).

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?

SDCL 36-11A-4.1 requires each wholesale distributor and outsourcing facility 'located within or outside of the state that provides services to outlets within the state' to be licensed annually by the Board of Pharmacy. SDCL 36-11A-1(15) defines an outsourcing facility as one compounding non-patient-specific sterile and nonsterile drugs that complies with FD&C Act §503B and is FDA-registered and inspected. The Board issues this credential through its 'Wholesale or Other Drug Distributors and 503B Outsourcing Facilities' license, which expires December 31. The Board's instructions say 503B applicants must provide an FDA inspection report (other inspection types are not accepted), within the general requirement that inspections be under four years old.

SDCL 36-11A-4.1 dates from SL 2017, ch 174. A 503B facility that also dispenses patient-specific prescriptions to South Dakota residents would also fall under the nonresident pharmacy licensing rules (SDCL 36-11-19.3); the Board's materials do not address this combination directly. ARSD 20:67 (drug distributors) does not mention outsourcing facilities by name.

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; South Dakota 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.

SDCL 34-20B-29 requires any person who prescribes or dispenses any controlled drug or substance in South Dakota to obtain a registration from the Department of Health, and SDCL 34-20B-1 defines 'dispense' to include prescribing and administering. Under ARSD 44:58:03:02.01 the fee is $150 for MDs, DOs, NPs, nurse midwives and PAs (non-refundable, not prorated), and under ARSD 44:58:03:01 the state registration expires on the same date as the registrant's DEA registration. No regulated activity may begin until the registration certificate is issued; practitioners working as agents of another registrant (administering but not prescribing) and institutional practitioners under a hospital's registration are exempt (ARSD 44:58:02:22).

Statutes current; the fee rule dates from 2009-07-01 and the expiration rule from 1998 (older than 2 years - fee possibly stale). Because the SD registration expires with the DEA registration, the rules imply the DEA registration exists when SD registers; the required order was not stated. A per-location rule was not found in the SD rules reviewed. The SD DOH web page for the registration could not be located without search.

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.

SDCL 34-20E-2.1 requires anyone holding a South Dakota controlled drug or substance registration (other than veterinarians) to register with the prescription drug monitoring program. SDCL 34-20E-11 states that nothing in the chapter requires a prescriber or dispenser to obtain information about a patient from the central repository prior to prescribing or dispensing a controlled substance, and bars civil liability for checking or not checking. South Dakota is not listed in the PDMP TTAC compilation of mandatory-use provisions. The PDMP is operated by the South Dakota Board of Pharmacy.

Chapter text read through the Legislature's statute API (sdlegislature.gov/api/Statutes/Statute/34-20E). 34-20E-11 dates from SL 2010, ch 175; registration duty from SL 2017, ch 157. Board rules (e.g. medical board opioid rules) were not searched; the federal SUPPORT Act Medicaid Schedule II check may still apply to SD Medicaid patients (not verified for SD).

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 South Dakota physicians may dispense to patients under their care after completing the Department of Health controlled substance registration and fee (reported $150), and that NPs and PAs may dispense when expressly allowed by the supervising physician. The statute and rule text were not reviewed.

The DOH page link comes from the vendor summary; its content was not reviewed.

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) Health care professionals treating patients in South Dakota by telehealth must be fully licensed in the state or employed by specified licensed facilities or agencies; consultation with a nonresident professional is governed by SDCL 36-2-9 (SDCL 34-52-2). (2) The provider must provide an appropriate face-to-face examination using real-time audio and visual technology before diagnosis and treatment if a face-to-face encounter would otherwise be required for the same service (SDCL 34-52-5), and the relationship must include diagnosis through history, examination and testing (SDCL 34-52-3, per CCHP). (3) Without a proper provider-patient relationship, a telehealth provider may not prescribe a controlled substance solely in response to an internet questionnaire or consult, including any telephone encounter (SDCL 34-52-6); this reaches Schedule III drugs such as testosterone. (4) IMLC: member.

Borderline: classified conditional because South Dakota has a statutory real-time audio-video exam requirement and a controlled-substance-specific bar on telephone-only prescribing without a proper relationship (an audio-video rule reaching Schedule III). Statutes date from 2019-2020 (SL 2019 ch 156; SL 2020 ch 151).

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 SD Board of Nursing's opinion 'Dermatological Procedures by Licensed Nurses' (revised November 2024) says RNs and LPNs may perform medical aesthetic services as part of a medically prescribed plan of care. An authorized provider (physician, CNP or PA) must review the history and assess the client for each episode of care (a series of unchanging treatments), in person or via telehealth, develop a treatment plan, and issue a written, signed order or annually reviewed protocol that specifies required training, supervision level and contraindications. RNs, with additional education and demonstrated competence and after their own nursing assessment, may inject FDA-approved neuromodulators and temporary dermal fillers; LPNs may inject neuromodulators under supervision. Products must come from SD-licensed wholesalers or 503B facilities, and nurse-owned aesthetic businesses must register as nursing corporations.

Revised November 2024 (month only). Board opinions do not have the force of law.

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 'Elective IV Infusion and Medication Therapy Guidelines' (approved 2022-11-09, revised 2023-11-16, editorial Nov. 2024) affirm that licensed nurses may administer elective IV therapy and additives for medical or wellness reasons on an order from a physician, NP or PA. The provider must either assess the client personally or write a protocol defining the history and assessment the nurse performs, plus a treatment plan with a specific order. Protocols must be written, signed, reviewed annually and specify training, contraindications and when to consult. RNs may not prescribe, order or procure drugs; LPNs may assist for stable clients 12 and older with the supervising provider readily available in person or electronically.

Unlike most neighbouring states, South Dakota expressly allows protocols for clients not previously examined by the provider.

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 South Dakota as strict, citing SDCL 36-4-8.1, and MedPath Compliance (reviewed 2026-06-20) lists it as a CPOM state (statute and board policy). The Board of Nursing separately requires CNP- or RN-owned aesthetic businesses to register as nursing corporations.

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 Nursing's 2024 dermatology opinion reports a Board of Medical and Osteopathic Examiners declaratory ruling on laser delegation determining that only physicians, NPs and PAs may use lasers, and it lists only 'light-based treatments (non-laser, non-ablative)' among procedures RNs and LPNs may perform.

The medical board's declaratory ruling itself (date and exact wording) was 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). South Dakota was not among them, but this research did not confirm its statutes. South Dakota's CLIA state agency is South Dakota Dept. of Health, Office of Health Care Facilities Licensure & Certification (SDCLIA@state.sd.us, 605-394-6173); 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 South Dakota's rule. South Dakota's lab regulator (CLIA state agency) is South Dakota Dept. of Health, Office of Health Care Facilities Licensure & Certification (SDCLIA@state.sd.us, 605-394-6173). 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. South Dakota 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?

South Dakota 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.