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?

S.C. Code §40-43-83 requires a Board of Pharmacy permit for out-of-state facilities that sell, distribute or dispense prescription drugs in South Carolina, and requires any out-of-state pharmacy shipping into the state to designate a registered agent. Board Regulation 99-43(B)(2) states that a pharmacy located outside South Carolina must obtain a Non-Resident Pharmacy Permit to dispense legend drugs or devices to a patient (or patient's agent) in the state. The application requires the resident-state permit and DEA registration, every operational inspection report from the last two years, current accreditations, a refrigerated-shipping policy, a sample label, photographs and an ownership chart. A pharmacy that compounds (sterile or non-sterile) must also file compounding training records, environmental and cleaning logs, formulas for its top five compounds, policies, and its latest hood/cleanroom certification, even if it is not yet shipping compounds into South Carolina. Instead of an in-person inspection, a pharmacist or knowledgeable person must appear before the Board or its committee. There is no separate nonresident sterile-compounding permit.

The statute's wording covers out-of-state facilities 'whose primary business is mail order pharmacy service', but §40-43-83(I) and R.99-43(B)(2) apply to any out-of-state pharmacy dispensing to South Carolina patients. Permits expire annually. The application form (rev. 1/20) charges a $420 fee, requires the PIC to attend an Application Review Committee meeting, and requires an inspection report dated after the application. Nonresident pharmacies dispensing controlled substances also need a South Carolina Controlled Substances Registration, and every permitted nonresident pharmacy must register with the South Carolina PMP or obtain an exemption. R.99-43 was amended effective May 22, 2026 (SCSR 50-5, Doc. No. 5422), and the nonresident-pharmacy text in that notice matches the prior version.

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.

S.C. Code §40-43-86(CC)(2)(f) allows pharmacists to compound on a practitioner's order for administration to patients in institutional or office settings, and bars offering compounds to other pharmacies for resale. Under §40-43-86(CC)(2)(h), physicians who administer compounded medications in an office or licensed ambulatory surgical facility may order and purchase them from the compounding pharmacy and store them for future use but not for resale. No individual-patient prescription is needed for each administration. Compounding in anticipation of prescriptions without a historical basis, or distributing without a patient/practitioner/pharmacist relationship, counts as manufacturing (§40-43-86(CC)(2)(g)). Institutional pharmacies may order and stock sterile and nonsterile compounds, with a chart order needed for each administration ((CC)(2)(i)). The Board of Pharmacy enforces these rules. This state allowance is broader than FDA's view that 503A compounding requires patient-specific prescriptions.

Subsection (CC)(1) says it applies to compounding by 'pharmacies permitted in the State of South Carolina'. The text does not say whether an out-of-state pharmacy holding a South Carolina Non-Resident Pharmacy Permit may ship office-use stock, and R.99-43(B)(2) frames that permit around dispensing to patients. Paragraph (h) refers to 'physicians', while (f) refers to 'practitioners'. §40-43-86 was last amended by 2024 Act No. 132 (eff. May 13, 2024). New R.99-48 (eff. May 22, 2026) sets interim compounding standards (the Board inspection forms in use on July 2, 2024) until permanent compounding regulations are adopted, and it does not change the office-use provisions.

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?

Amended R.99-43(D) (effective May 22, 2026) requires an Outsourcing Facility Permit for any compounding facility that sells, dispenses, transfers or distributes non-patient-specific compounded products in South Carolina, and the facility must be FDA-registered under 503B and follow cGMP. Every applicant must name a pharmacist-in-charge with an active South Carolina pharmacist license and submit policies on cold-chain shipping, temperature and humidity, QC/QA, recalls, complaints, training, aseptic process validation, and environmental and personnel monitoring. Out-of-state applicants must also submit their resident-state outsourcing permit, DEA registration, other state permits, and the most recent FDA establishment inspection report (with any 483s, responses and warning letters). They must also submit all operational inspection reports from the last two years, one showing at least six months of operation. A facility that dispenses patient-specific prescriptions into South Carolina must also hold a South Carolina pharmacy permit. The PIC must report discipline, 483s or warning letters, and recalls to the Board within 30 days.

2024 Act No. 132 (H.3592) defined 'outsourcing facility', added §40-43-197 (practitioners may buy directly from outsourcing facilities without patient orders), and directed the Board to write outsourcing regulations; the amended R.99-43(D) followed in May 2026. The earlier R.99-43(D) and the Board's Non-Resident Outsourcing Facility application (09/29/2023 v1, $700 fee, Application Review Committee appearance) required the facility to hold or concurrently apply for a South Carolina pharmacy or wholesale distributor permit. The 2026 text keeps that only for patient-specific dispensing, so confirm current forms with the Board. A secondary source (Lighthouse, 2026-07-07) says the PIC must also be the PIC in the resident state and that existing permittees have until the June 30, 2027 renewal to comply; this was not found in the State Register text reviewed. Amended R.99-43(D)(5) requires outsourced products to come from South Carolina-permitted facilities and bars redistribution by anyone other than the compounding outsourcing facility. The Board's 2026 regulation-update PDF is a scanned image and could not be text-verified.

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 Carolina 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.C. Code 44-53-290 requires every person who dispenses controlled substances to obtain a registration, with a separate registration at each principal place of business or professional practice, and 44-53-110 defines 'dispense' to include prescribing and administering. The DPH Bureau of Drug Control states that providers are not authorized to prescribe, administer, possess or dispense controlled substances without an active SC Controlled Substances Registration; its practitioner form (DPH Form 1174A) covers physicians, APRNs and PA-Cs and requires a copy of the SC professional license. MD/DO registrations expire every October 1 and other classes every April 1 (44-53-280); there is no grace period, and reinstating an expired registration requires a new application plus a $100 penalty.

The code text still names DHEC as 'the Department'; the Bureau of Drug Control now operates under the SC Department of Public Health (DPH) per the agency's own pages. Registration fee amounts and the order relative to DEA were not shown on the pages reviewed. Health clinics use a separate application signed by the medical director.

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.

S.C. Code Sec. 44-53-1645(A) requires a practitioner or authorized delegate to review the patient's controlled substance prescription history and opioid-antidote administration history in the prescription monitoring program before issuing a prescription for a Schedule II controlled substance, with the review discussed with the practitioner and documented. Exemptions include hospice-certified patients, supplies of five days or less, established patients treated for a chronic condition (who must still be reviewed at least every three months), approving administration by a licensed provider, residents of skilled nursing, nursing home, community residential care or assisted living facilities whose medications are staff-controlled, and temporary exigent circumstances that are documented. A practitioner whose EHR automatically displays PMP history is deemed compliant.

History: 2017 Act No. 91, eff. May 19, 2017; 2019 Act No. 65, eff. January 1, 2021. PDMP TTAC also lists Sec. 44-53-363.

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 Carolina physicians may dispense to their patients, that a dispensing permit is required for 'non-owned' sites (not directly and wholly owned by the dispensing practitioner, which catches many employed and group physicians), and that controlled substances require the state controlled substance registration. The statute and rule text were not reviewed.

Confirm with the South Carolina Board of Pharmacy (LLR).

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) Physicians practicing via telemedicine must hold a South Carolina license; exceptions cover informal consultation requested by a South Carolina physician and care between in-person visits under an existing treatment plan for specialty care established in person in another state, and controlled-substance prescribers must hold a South Carolina Bureau of Drug Control registration (S.C. Code 40-47-37(A)). (2) An appropriate evaluation is required before treatment but need not be in person if the physician can diagnose and treat within the standard of care; a relationship may not be established by telemedicine to prescribe when an in-person exam is necessary for diagnosis, and questionnaire-only prescribing is unprofessional (40-47-37(C); 40-47-113). (3) Telemedicine-only practice must follow the PMP and the Ryan Haight Act and may not include Schedule II-narcotic or Schedule III-narcotic prescriptions except for hospital patients, buprenorphine MAT, palliative care or hospice, or Board-authorized programs; non-narcotic Schedule III drugs such as testosterone are outside this ban. (4) IMLC: not a member.

The South Carolina controlled-substance registration applies to every controlled-substance prescriber, not only telehealth, so it did not change the classification. The narcotic-only limit is treated like an opioid-only limit. 40-47-37 last amended 2024 (Act No. 120, eff. 3/11/2024).

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?

SC Board of Nursing Advisory Opinion #39 (revised Nov. 2023) says cosmetic dermal fillers are within RN scope only if the supervising physician/APRN is immediately available on site and can respond within five minutes; the physician/APRN performs and documents an initial assessment (an RN cannot establish the practitioner-patient relationship); the RN completes documented training with supervised practice; injections occur in a clinical setting with sterility and resuscitation capability and written policies; and ongoing competency is documented. LPNs are not included for fillers. The opinion does not mention cosmetic botulinum toxin, and no separate SC nursing opinion on cosmetic Botox was found.

Revision month only (Nov. 2023; recorded as 2023-11-01). Advisory opinions #1–#82 were scanned on 2026-09-23; the only Botox opinion (#70) concerns endoscopic/cystoscopic injection, not cosmetic use. Check with the Board for neuromodulators.

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 2023 joint advisory opinion on retail IV therapy businesses says only a physician, PA or APRN may diagnose, assess and recommend IV treatment, and must personally perform and document a history and physical, diagnosis and plan and obtain informed consent. A "medical director" who is merely available, and standing orders for the RN to follow, do not satisfy these duties and may amount to aiding unlicensed practice. The relationship may be established by telemedicine under S.C. Code §40-47-37 if the standard of care is met. Patients selecting additives from a menu is not acceptable, and mixing additives is compounding that brings Pharmacy Act requirements (a pharmacy permit unless the facility is 100% practitioner-owned).

Over two years old (possibly stale) but still linked from the Board of Medical Examiners' page on 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?

Permit Health's 2025 guide classifies South Carolina as strict, citing S.C. Code §40-47-10 and cases including Ezell v. Ritholz (1938), Wadsworth v. McRae Drug (1943) and McMillan v. Durant (1993); MedPath Compliance (2026) also lists it as a CPOM state. The 2023 joint IV opinion notes that a pharmacy permit is required for IV compounding unless the facility is 100% practitioner-owned.

Case law and statute 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?

The SC Board of Medical Examiners' guidance on surgery using lasers, pulsed light and RF devices (adopted 2024-05-07) treats these as the practice of medicine; they may be delegated to trained PAs (under supervision) and NPs (under a practice agreement), and practitioners must examine each patient before the first treatment or before authorizing a non-physician to treat. Its 2025 laser summary adds that RNs may perform under direct supervision of a physician, APRN or PA, and certified medical assistants may use non-ablative lasers under direct supervision (S.C. Code §40-47-196). Board of Nursing Advisory Opinion #39 limits RN laser hair and spider-vein removal to cases where the supervising physician is on site and can respond within five minutes, with a prior physician/APRN assessment and documented training.

The 2025 summary shows only the year (recorded as 2025-01-01).

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). South Carolina was not among them, but this research did not confirm its statutes. South Carolina's CLIA state agency is South Carolina Dept. of Public Health, Healthcare Quality (SC_CLIA@dph.sc.gov, 803-545-4203); 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 Carolina's rule. South Carolina's lab regulator (CLIA state agency) is South Carolina Dept. of Public Health, Healthcare Quality (SC_CLIA@dph.sc.gov, 803-545-4203). 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 Carolina 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 Carolina 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.