Regulations research

FDA and state rules, for what you actually buy.

Search a drug, ingredient or device for its live FDA record, or pick your state and a category to see the federal rules and what your state adds — each answer with its citation and source.

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Licenses and compliance: the states a vendor is licensed in and the documents it publishes, each marked verified or not
Every answer sourced
Everything for Arkansas ↓
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Lab panels & genetic tests

FDA pathway: CLIA (CMS) for labs | Device (IVD) for test kits | FDA LDT rule vacated

Any lab testing human specimens for health purposes needs a CLIA certificate matched to test complexity; FDA's 2024 LDT rule was vacated by a court on March 31, 2025 and FDA formally reverted its regulation on Sept 19, 2025.

On MedGrid as: Lab Panels & Requisitions · Lab Panels

The federal rules

CLIA certificates by test complexityTests are waived, moderate complexity (including provider-performed microscopy) or high complexity; each lab must be CLIA-exempt or hold a certificate of registration, waiver, PPM, compliance or accreditation.

Waived tests are those cleared for home use, so simple that errors are unlikely, or posing no reasonable risk if done wrong. CMS says CLIA covers about 320,000 lab entities; certificates can be looked up in CMS QCOR. A clinic ordering from a reference lab relies on that lab's CLIA certificate.

FDA's LDT rule vacated and reversedFDA's May 6, 2024 rule adding labs to the definition of IVD manufacturers was vacated by a federal district court on March 31, 2025; on Sept 19, 2025 FDA issued a final rule restoring the prior text of 21 CFR 809.3(a).

LDTs therefore remain outside FDA's phased premarket framework; CLIA still applies to the lab.

Current as of 2026-09-23

Direct-to-consumer and genetic health risk testsFDA reviews moderate- to high-risk DTC tests; a company's first genetic health risk test needs FDA clearance, after which some additional GHR tests may be offered without premarket review under special controls.

FDA generally does not review low-risk ancestry or wellness genetic tests. State direct-access-testing laws decide whether consumers can order tests without a clinician.

Current as of 2019-12-20

GINAGINA Title II bars employers with 15+ employees from using genetic information in employment decisions and generally from requesting or buying it; Title I covers health insurance.

Title II is enforced by the EEOC; Title I by the Departments of Labor, HHS and Treasury.

Current as of 2026-09-23

Changing now

What Arkansas adds

State clinical laboratory licensing (beyond CLIA)Not confirmed. No Arkansas lab license beyond CLIA was found in the sources reviewed, but its absence was not verified.Not confirmed

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). Arkansas was not among them, but this research did not confirm its statutes. Arkansas's CLIA state agency is Arkansas Dept. of Health, Health Facility Services (adh.hfs@arkansas.gov, 501-661-2201); 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.

Not confirmed

Current as of 2026-05-01 · Not independently confirmed

Direct-to-consumer lab testingNot confirmed whether Arkansas consumers may order lab tests without a practitioner order. Practitioner-ordered panels are not affected.Not confirmed

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 Arkansas's rule. Arkansas's lab regulator (CLIA state agency) is Arkansas Dept. of Health, Health Facility Services (adh.hfs@arkansas.gov, 501-661-2201). The question matters for take-home and consumer test kits, not for panels a clinician orders.

A commercial 2026 guide (Just Labs) describes Arkansas as permissive, except for controlled-substance tests; not confirmed against state law. The ADLM figure dates from 2019 (older than 2 years).

Not confirmed

Current as of 2026-09-23 · Not independently confirmed

Arkansas at a glance

Every topic we research, for Arkansas. Open any line for the rule, its citation and the source.

Pharmacy & compounding

Out-of-state pharmacies shipping into the stateOut-of-state pharmacies need an Arkansas out-of-state pharmacy license to ship prescriptions into Arkansas, with an Arkansas-licensed pharmacist on staff as pharmacist-in-charge.License required

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?

Ark. Code §17-92-401 requires a pharmacy outside Arkansas that routinely ships, mails or delivers dispensed legend drugs into Arkansas to hold a Board pharmacy license and follow Arkansas law for its Arkansas prescriptions. It must have on staff an Arkansas-licensed pharmacist designated pharmacist-in-charge for the Arkansas license and register a resident agent with the Secretary of State. 17 CAR §160-1401 adds that this Arkansas PIC must be an employee present at the pharmacy at least 50% of its open hours, up to 20 hours a week. It also requires a home-state license, a toll-free pharmacist line (40 hours, 6 days a week), retrievable records, and Board inspection, though the Board may accept home-state inspection reports. The Board may exempt pharmacies whose Arkansas dispensing is limited to isolated transactions.

The Board's rules were recodified into the Code of Arkansas Rules (17 CAR Part 160); older sources cite the former 'Regulation 04' numbering. The source documents are titled 'January 2026' (Practice Act) and 'July 2026' (Rules).

Ark. Code Ann. §17-92-401; 17 CAR §160-1401

Current as of 2026-09-23 · Checked against the primary source

Office-use compounding from 503A pharmaciesArkansas requires compounding pharmacies to comply with all of federal section 503A and permits office-use supply only for veterinarians; non-patient-specific product for human clinics comes through Arkansas-permitted 503B outsourcing facilities.Not allowed

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.

17 CAR §160-2201(d) requires pharmacies that compound to comply with 'all requirements of Section 503A' of the FD&C Act, which FDA reads as requiring patient-specific prescriptions. The compounding rule allows distribution without a patient-specific prescription only for veterinary office use (§160-2201(i)(4)-(5)). Even then, the product must come from an Arkansas-licensed Class A pharmacy or an FDA-registered, Arkansas-permitted 503B and may not be redistributed. No comparable human office-use provision exists in the rules or the Pharmacy Practice Act. Ark. Code §17-92-121 instead lets an Arkansas-permitted 503B outsourcing facility sell compounded products to Arkansas-licensed providers for administration to patients in a clinic. The Arkansas State Board of Pharmacy enforces.

The rules do not use the word 'prohibited' for human office use. The 'no' answer reflects the 503A-compliance requirement, the veterinary-only office-use provision, and the 503B clinic channel in §17-92-121. Confirm with the Board (501-682-0190).

17 CAR §160-2201(d), (i)(4)-(5); Ark. Code Ann. §17-92-121

Current as of 2026-09-23 · Checked against the primary source

503B outsourcing facilities shipping into the stateAn out-of-state 503B outsourcing facility must hold an Arkansas State Board of Pharmacy permit ('503B Outsourcer') with an Arkansas-licensed pharmacist-in-charge before shipping into Arkansas, and may sell only to Arkansas-licensed pharmacies, facilities and providers.State license required

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?

17 CAR §160-2603 requires every outsourcing facility that distributes prescription drugs, including by shipping into Arkansas, to register with the Board for a permit (biennial renewal). 17 CAR §160-2601(8) defines an outsourcing facility as an FDA-registered 503B that is licensed under the wholesale distribution rules as a '503B Outsourcer'. It must have an Arkansas-licensed pharmacist-in-charge on staff at least 32 hours a week and may not provide patient-specific prescriptions unless also licensed as a pharmacy. Ark. Code §17-92-121 limits sales by a Board-permitted 503B to Arkansas-licensed retail pharmacies (for dispensing), health care facilities, and providers (for administration in a clinic). It bars sales to wholesalers, repackagers, relabelers, marketing firms or other entities, and requires cGMP compliance (21 CFR Parts 210-212).

The 32-hour Arkansas-licensed PIC requirement sits in the definition of 'outsourcing facility' in 17 CAR §160-2601(8)(E), which on its face applies to out-of-state 503Bs. 17 CAR §160-2203 governs Arkansas retail pharmacies dispensing 503B products (counseling and extra label items).

Ark. Code Ann. §17-92-121; 17 CAR §160-2601(8); 17 CAR §160-2603; 17 CAR §160-2203

Current as of 2026-09-23 · Checked against the primary source

FDA compounding MOUArkansas has not signed FDA's standard compounding MOU, so under the statute its 503A pharmacies are limited to 5% out-of-state distribution, although FDA is not enforcing that limit while it rewrites the MOU.Not signed

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; Arkansas 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.

FD&C Act §503A(b)(3)(B) (21 U.S.C. 353a(b)(3)(B))

Current as of 2026-08-28 · Checked against the primary source

Prescribing, dispensing & telehealth

State controlled-substance registrationArkansas does not issue a state controlled substance registration to prescribing practitioners; its state Controlled Substance Registration Certificate is limited to research, instruction, chemical analysis and animal training/euthanasia.DEA + state license only

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 Arkansas Department of Health (Pharmacy Services) states that persons engaged in research with controlled substances, instructional activities, chemical analysis, or animal training and animal euthanasia must obtain a Controlled Substance Registration Certificate from the State of Arkansas; clinical practitioners are not listed. ADH's March 2026 applicant memorandum describes the state registration as a registration to conduct such 'procedures' and tells applicants they must also apply to DEA. Prescribing practitioners therefore rely on their Arkansas professional license plus DEA registration.

Answer is inferred from the agency's statement of who must obtain the state certificate; the page does not expressly say 'practitioners are exempt', and Ark. Code 5-64-301 et seq. could not be opened in this session. Contact ADH Pharmacy Services (501-661-2325) to confirm.

Arkansas Department of Health, Pharmacy Services - Controlled Substances (registration scope)

Current as of 2026-03-05 · Checked against the primary source

PDMP check before prescribingArkansas requires a PDMP check every time a Schedule II or III opioid is prescribed and the first time a benzodiazepine is prescribed; testosterone is not covered.Required for some drugs only

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.

Under the Arkansas Department of Health PDMP rules, a prescriber must check the PDMP each time prescribing a Schedule II or Schedule III opioid and the first time prescribing a benzodiazepine to a patient; licensing boards must adopt matching rules. Exemptions: controlled substances administered immediately before/during surgery, during recovery in a healthcare facility, in a healthcare facility, or in emergencies; palliative care, hospice and nursing home residents; and system failures. Oncologists must check at an initial malignant diagnosis and every three months during treatment. Otherwise PDMP use is 'encouraged' only.

Source older than 2 years - possibly stale (rule effective 12/28/2023). The PDMP TTAC list cites Ark. Code § 20-7-604 and board rules (e.g., Arkansas State Medical Board Regulation 19, AAC 060.00.1-19) for the mandate; statute text itself was not opened. Testosterone (C-III, non-opioid) is not caught.

Rules Pertaining to Arkansas Prescription Drug Monitoring Program, Sec. IV(e)(2) (promulgated under Ark. Code § 20-7-613); Ark. Code §§ 20-7-601 to -615

Current as of 2023-12-28 · Checked against the primary source

Physicians dispensing from the officeArkansas physicians need prior approval from the Arkansas State Medical Board, on a showing of need, before dispensing legend drugs, with exemptions that do not cover controlled substances.Allowed with permit or limits

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.

Under 17 CAR 140-701 a physician who wants to dispense legend drugs must apply to the Arkansas State Medical Board and demonstrate the need before approval. Exempt: physicians dispensing before April 12, 2013; physicians dispensing only non-controlled injectables; and dispensing of topicals, naloxone, nicotine replacement, contraceptives, non-controlled acute-care drugs for up to 14 days, and initial non-controlled maintenance therapy (hypertension, diabetes, cholesterol) for up to 30 days. Dispensing physicians must keep records of all distributions, label drugs with patient and prescriber information, and make records available to board inspectors. Dispensing a controlled substance such as testosterone therefore needs board approval.

Rule page shows no effective date; access date used.

17 CAR 140-701 (authority Ark. Code 17-95-303)

Current as of 2026-09-23 · Checked against the primary source

Prescribing by telehealthArkansas requires an Arkansas license, and a physician using telemedicine may not prescribe Schedule II-V controlled substances without an in-person exam or a consult/referral relationship.Allowed with extra conditions

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.

Out-of-state physicians who perform patient-care acts for patients in Arkansas by electronic means are practicing medicine in Arkansas and are regulated by the Arkansas State Medical Board (Ark. Code 17-95-206). A professional relationship can be established by telemedicine that meets the in-person standard of care, but not by questionnaire, email, text or fax alone (Ark. Code 17-80-402, -403). Under the Medical Board's rule, a physician using telemedicine may not prescribe any Schedule II-V controlled substance, including testosterone, unless the physician has seen the patient in person or the relationship exists through consultation or referral. IMLC: passed, implementation delayed.

IMLC map shows Arkansas 'Passed; Implementation Delayed' (dated 3/12/2025).

Ark. Code 17-95-206; Ark. Code 17-80-402, 17-80-403; Ark. Admin. Code 060.00.16-005

Current as of 2026-05-26 · From a dated compilation

Aesthetics, IV therapy & practice ownership

Who may inject neuromodulators and fillersNo Arkansas rule or board statement on who may inject Botox or fillers was found.Not confirmed

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 Arkansas State Medical Board's delegation rule (17 CAR pt. 140, subpt. 25, proposed amendments July 2025) covers delegation to unlicensed medical assistants: drug administration may be delegated only for drugs not requiring substantial specialized judgment, only within the delegating physician's or PA's offices, and after the physician evaluates patient acuity and the assistant's competency. No Arkansas State Board of Nursing or Medical Board statement specific to RN administration of neuromodulators or fillers was located.

The fetched delegation rule is a markup of proposed amendments (draft dated 2025-07-08). Check with the Arkansas State Board of Nursing.

Current as of 2026-09-23 · Not independently confirmed

IV hydration and vitamin therapyArkansas does not license IV spas, but its Board of Nursing says IV hydration needs an order from a provider with prescriptive authority who has established a provider-patient relationship and prescribes for the individual patient, and only licensed nurses should start the IV.Extra requirements apply

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?

An Arkansas State Board of Nursing 'APRN Corner' article (ASBN Update) says IV spa hydration facilities are not individually licensed or regulated in Arkansas, but the services are medical: they require an order or prescription from a licensed provider, including a provider-patient relationship, determination of need, documentation and record keeping. Only licensed nurses should insert the IV and administer fluids, and providers with active prescriptive authority should prescribe the fluid and additives for individual patients. It cautions that mixing products into saline may be compounding, and flags transport and storage problems for mobile services.

This is a board newsletter article, not a formal position statement or rule. Date inferred from the file name '2.4.26' (it was cited by Nebraska in Jan. 2026 as ASBN Update Edition 135); treat the date as approximate.

ASBN Update, 'IV Spa Hydration, Should I Be Doing This?' (APRN Corner)

Current as of 2026-02-04 · Checked against the primary source

Corporate practice of medicine / med spa ownershipCompilations describe Arkansas as having a moderate corporate practice of medicine doctrine based on statute and an Attorney General opinion.CPOM with exceptions

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 Arkansas as moderate, citing Ark. Code Ann. §§17-95-202 and 4-29-309(a) and Ark. Att'y Gen. Op. No. 2014-118. MedPath Compliance (reviewed 2026-06-20) lists Arkansas as a CPOM state based on statute and AG opinion.

Ark. Code Ann. §§17-95-202, 4-29-309(a); Ark. Att'y Gen. Op. No. 2014-118 (as reported by Permit Health)

Current as of 2025-12-23 · From a dated compilation

Who may operate aesthetic lasersNo Arkansas rule on who may operate cosmetic lasers was confirmed; check with the Arkansas State Medical Board.Not confirmed

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 Arkansas State Medical Board's rules page (checked 2026-09-23) links only the physician assistant and delegation subparts; no laser-specific rule was located. A 2024–2026 vendor blog lists physicians, RNs, PAs and electrologists under physician supervision, but that could not be verified against an official source.

Current as of 2026-09-23 · Not independently confirmed

Labs, regenerative medicine & cosmetics

State clinical laboratory licensing (beyond CLIA)Not confirmed. No Arkansas lab license beyond CLIA was found in the sources reviewed, but its absence was not verified.Not confirmed

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). Arkansas was not among them, but this research did not confirm its statutes. Arkansas's CLIA state agency is Arkansas Dept. of Health, Health Facility Services (adh.hfs@arkansas.gov, 501-661-2201); 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.

Not confirmed

Current as of 2026-05-01 · Not independently confirmed

Direct-to-consumer lab testingNot confirmed whether Arkansas consumers may order lab tests without a practitioner order. Practitioner-ordered panels are not affected.Not confirmed

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 Arkansas's rule. Arkansas's lab regulator (CLIA state agency) is Arkansas Dept. of Health, Health Facility Services (adh.hfs@arkansas.gov, 501-661-2201). The question matters for take-home and consumer test kits, not for panels a clinician orders.

A commercial 2026 guide (Just Labs) describes Arkansas as permissive, except for controlled-substance tests; not confirmed against state law. The ADLM figure dates from 2019 (older than 2 years).

Not confirmed

Current as of 2026-09-23 · Not independently confirmed

State laws on stem cell / regenerative therapiesNo Arkansas law specific to stem cell, exosome or regenerative therapies was found, so FDA rules and general medical-practice rules apply.No state-specific law (FDA rules apply)

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. Arkansas 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.

State rules for cosmetics and sunscreenNo Arkansas-specific cosmetic or sunscreen requirements beyond federal law (MoCRA/FDA) were found.None found beyond federal

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?

Arkansas 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.

None found

Current as of 2026-03-13 · From a dated compilation

Compare every state

Office-use compounding from 503A pharmacies. 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.

Allowed with limits · 17Not allowed · 23Not confirmed · 11
Alaska: Not confirmedAlabama: Allowed with limitsArizona: Allowed with limitsCalifornia: Allowed with limitsColorado: Not allowedConnecticut: Allowed with limitsWashington DC: Not confirmedDelaware: Not confirmedFlorida: Not allowedGeorgia: Not allowedHawaii: Not confirmedIowa: Not confirmedIdaho: Not confirmedIllinois: Allowed with limitsIndiana: Not confirmedKansas: Allowed with limitsKentucky: Not allowedLouisiana: Not allowedMassachusetts: Not allowedMaryland: Not allowedMaine: Not allowedMichigan: Allowed with limitsMinnesota: Not allowedMissouri: Not allowedMississippi: Not allowedMontana: Not confirmedNorth Carolina: Allowed with limitsNorth Dakota: Allowed with limitsNebraska: Allowed with limitsNew Hampshire: Allowed with limitsNew Jersey: Not allowedNew Mexico: Not allowedNevada: Not allowedNew York: Not allowedOhio: Not allowedOklahoma: Allowed with limitsOregon: Not allowedPennsylvania: Not allowedRhode Island: Not allowedSouth Carolina: Allowed with limitsSouth Dakota: Not confirmedTennessee: Allowed with limitsTexas: Allowed with limitsUtah: Not allowedVirginia: Allowed with limitsVermont: Not allowedWashington: Allowed with limitsWisconsin: Not confirmedWest Virginia: Not confirmedWyoming: Not allowedArkansas: Not allowedConnecticut: Allowed with limitsCTWashington DC: Not confirmedDCDelaware: Not confirmedDEMassachusetts: Not allowedMAMaryland: Not allowedMDNew Hampshire: Allowed with limitsNHNew Jersey: Not allowedNJRhode Island: Not allowedRIVermont: Not allowedVT

The federal floor, for every category

Two federal compounding lanes: §503A pharmacies vs §503B outsourcing facilitiesA §503A pharmacy (or physician) compounds for an identified patient on a prescription; a §503B outsourcing facility is FDA-registered, follows CGMP, and is the only federal lane for non-patient-specific office stock.

Under §503A, a state-licensed pharmacist or physician may compound for an identified individual patient on a valid prescription, or in limited anticipatory quantities (no more than a 30-day supply based on the compounder's own prescription history). 503A compounders are not required to follow CGMP and are not required to report adverse events to FDA. Under §503B, an outsourcing facility registers with FDA, compounds under CGMP, is inspected on a risk-based schedule, must report adverse events, and may distribute non-patient-specific product to hospitals, clinics and practitioners for office use. Neither lane makes a compounded drug 'FDA-approved'. Both lanes restrict 'essentially copies' of approved or marketed drugs and restrict which bulk ingredients may be used. FDA keeps a public list of registered outsourcing facilities (content current as of 09/08/2026).

'Essentially a copy' of an approved or commercially available drugFDA treats a compounded drug with the same active ingredient, a similar strength and a usable route as a marketed product as 'essentially a copy' unless the prescriber documents a patient-specific significant difference on the prescription.

503A (final guidance, Jan 2018): a drug is not 'commercially available' if it is discontinued or is in 'currently in shortage' status on FDA's drug shortage list. FDA generally considers a compounded drug a copy if it has the same API in the same, similar or easily substitutable strength by a route the commercial product can be used by. The prescriber's determination must name the change and the significant difference for that patient; a patient name plus formulation is not enough, and lower price does not count. FDA does not consider copies to be made 'regularly or in inordinate amounts' if the compounder fills four or fewer such prescriptions per calendar month. 503B (final guidance, Jan 2018): outsourcing facilities may not compound drugs identical or nearly identical to an approved drug unless it is on the shortage list; otherwise a prescriber's determination of a clinical difference must be noted on the prescription or order.

Office use / office stock of compounded drugs (federal position)FDA's position is that §503A compounding requires a prescription for an identified patient; clinics wanting non-patient-specific office stock are directed to §503B outsourcing facilities.

FDA's final 503A prescription-requirement guidance (Dec 2016) says hospitals, clinics and practitioners can obtain non-patient-specific compounded drugs from outsourcing facilities registered under §503B, which may distribute sterile and non-sterile office-use product. 503A anticipatory compounding is limited to no more than a 30-day supply based on the compounder's own prescription history. Some states allow limited 503A office use under state law, but the federal 503A exemptions still depend on patient-specific prescriptions (see state topic office_use_503a).

503B products may not be resold by anyone other than the outsourcing facilitySection 503B(a)(8) bars anyone other than the outsourcing facility from selling or transferring its compounded drugs, so a clinic, distributor or marketplace that takes ownership may not resell 503B product.

FDA's June 2023 draft guidance (still draft) says the drug should go from the outsourcing facility to the entity that dispenses or administers it. FDA does not intend to apply the prohibition to transfers to common carriers, third-party logistics providers, regulators, returns processors, waste handlers or contract test labs, or to recall-related transfers. A state-licensed pharmacy may dispense 503B product against a patient-specific prescription. Clinic-to-clinic resale is the core concern.

Which bulk ingredients compounders may use (503A Categories 1/2/3; 503B bulks list)A 503A compounder may use a bulk ingredient only if it has a USP/NF monograph, is a component of an FDA-approved drug, or is on the 503A bulks list; FDA tolerates interim 'Category 1' substances, flags 'Category 2' as significant safety risks, and treats 'Category 3' as lacking support.

FDA's category list was updated May 14, 2026. 503A Category 2 now contains only cesium chloride, domperidone, germanium sesquioxide, ibutamoren mesylate, kisspeptin-10 and quinacrine (intrauterine use). Category 1 includes glutathione, methylcobalamin, NAD, NADH, enclomiphene citrate, GHK-Cu (non-injectable routes only), vasoactive intestinal peptide and others. GHRP-2, GHRP-6, mechano growth factor and thymulin are in Category 3. BPC-157, TB-500, CJC-1295, ipamorelin, AOD-9604, Selank, Semax, epitalon, MOTs-C, dihexa, KPV and thymosin alpha-1 are in no category, so they do not get Category 1 enforcement discretion. FDA does not intend to categorize substances nominated on or after Jan 7, 2025. The final 503B bulks list is short (e.g., diphenylcyclopropenone, glycolic acid topical up to 70%, quinacrine oral, squaric acid dibutyl ester, trichloroacetic acid); 503B Category 2 includes GHRP-2, GHRP-6, ipamorelin acetate, ibutamoren, tranilast and others.

Biologics (including hCG, tesamorelin, somatropin) cannot be compounded under 503A/503BSince March 23, 2020, protein products approved as drugs became licensed biologics, and FDA says biological products are not eligible for the 503A or 503B compounding exemptions.

The BPCI Act transition on March 23, 2020 deemed approved NDAs for biological products to be BLAs. FDA's transition list includes chorionic gonadotropin (Pregnyl, Novarel, Fresenius chorionic gonadotropin, Ovidrel), menotropins, follitropins, hyaluronidase, somatropin and tesamorelin acetate (Egrifta/Egrifta SV). FDA's notice to compounders states that 'biological products will not be eligible for the exemptions for compounded drugs under sections 503A and 503B'. Separate FDA guidance (Jan 2018) describes limited conditions for mixing, diluting or repackaging licensed biologics outside their labeling.

'Research Use Only' / 'not for human consumption' productsFDA treats RUO-labeled peptides and GLP-1s as unapproved drugs when marketing, dosing information or bundled syringes/bacteriostatic water show human use; the disclaimer does not make them lawful to administer to patients.

FDA's GLP-1 safety page says companies sold products falsely labeled 'for research purposes' or 'not for human consumption' with dosing instructions for human use. FDA has issued repeated warning-letter rounds to peptide/RUO sellers in 2026 (e.g., letters dated March 31, 2026 to Gram Peptides and others; June 17, 2026 to Wholesale Peptide; August 24, 2026 to Royal Peptides and others). Import Alert 66-41 (unapproved new drugs promoted in the U.S.) has listed, for example, a firm offering PT-141 peptide. RUO material is not a USP-grade or approved-drug-component bulk ingredient for compounding and is not a prescription drug a clinician can lawfully buy for patient use.

FDA drug shortage list and why it matters for compoundingA drug in 'currently in shortage' status is not 'commercially available', so 503A/503B compounders may make copies of it; when FDA marks the shortage resolved, that permission ends (503B facilities may finish existing orders for up to 60 days).

The 503A copies guidance says a drug appears on the shortage list only if it is in 'currently in shortage' status, not 'resolved'. FDA's shortage-compounding page says compounders must still meet all other 503A conditions (including a valid patient-specific prescription), and FDA 'may take action if an outsourcing facility continues to fill new orders after the approved drug is removed from FDA's drug shortage list, or if it continues to fill existing orders more than 60 days after the drug has been removed.' The GLP-1 episode shows the effect: large-scale semaglutide and tirzepatide compounding depended on shortage status and ended after FDA resolved the shortages. A prescriber or compounder relying on a shortage should note on the prescription that the drug was on the list and the date checked.

FDA Standard MOU on interstate distribution of 503A compounded drugsThe October 2020 standard MOU is suspended after a 2021 court remand; FDA is not enforcing the statutory 5% out-of-state limit and plans a new rule, with a proposed rule projected for November 2026.

Section 503A limits a pharmacy in a state without an FDA MOU to distributing no more than 5% of its compounded prescriptions out of state. FDA published a final standard MOU in October 2020, but a federal court remanded it in September 2021. FDA 'considers the standard MOU published in October 2020 to be suspended' and, per its Oct 21, 2022 Federal Register notice, will not enforce the 5% limit until a final rule and updated MOU are published. The Fall 2025 Unified Agenda lists RIN 0910-AI71 ('Distribution of Compounded Drug Products Under Section 503A') at the proposed-rule stage with an NPRM projected for 11/2026. State nonresident-pharmacy licensing still applies (see state topics nonresident_pharmacy and fda_mou).

DEA telemedicine prescribing of controlled substances (Ryan Haight Act flexibilities)Through December 31, 2026, DEA-registered practitioners may prescribe Schedule II–V controlled substances by telemedicine without a prior in-person visit under a fourth temporary extension; the permanent special-registration rule is still pending.

The Ryan Haight Act generally requires an in-person medical evaluation before prescribing controlled substances over the internet. DEA and HHS published the Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities (90 FR 61301, Dec 31, 2025), effective Jan 1 – Dec 31, 2026. Prescriptions must still be for a legitimate medical purpose and comply with federal and state law; state telehealth and controlled-substance rules still apply (see telehealth_rx, state_csr, pdmp_mandate). The separate buprenorphine (opioid use disorder) telemedicine final rule and the VA continuity-of-care final rule, both published Jan 17, 2025, took effect Dec 31, 2025 after two delays (90 FR 13410). A Federal Register search on 2026-09-23 found no DEA special-registration final rule published in 2026. The Special Registrations for Telemedicine final rule was reported to be in OMB review as of late August 2026, with a final rule forecast for November 2026. Without a new rule or another extension, the in-person requirement returns on Jan 1, 2027.

FTC health-claim substantiation (advertising)The FTC requires competent and reliable scientific evidence, generally randomized controlled human trials, before a marketer makes health-benefit claims for any health product, including devices, tests, supplements and apps.

The FTC's Health Products Compliance Guidance (Dec 2022) replaced the 1998 supplement advertising guide. Marketers must have substantiation for every objective claim, express or implied, before it runs; for health benefits this generally means randomized, controlled human clinical testing. Qualifying disclosures must be clear and conspicuous, and advertisers are liable for misleading testimonials and endorsements. This sits alongside FDA's rules: FDA regulates labeling and intended use, and FDA warning letters in 2025–2026 target 'same as brand' and 'FDA-approved' claims for compounded drugs.

Current as of 2026-09-23

Adverse event reporting (MedWatch; 503B mandatory reporting)Clinicians and patients can report problems with drugs, biologics, devices and cosmetics to FDA's MedWatch voluntarily; 503B outsourcing facilities must report adverse events, while 503A pharmacies are not federally required to.

MedWatch accepts voluntary reports for prescription and OTC drugs, biologics (including human cell and tissue products), medical devices, combination products and cosmetics. Manufacturers, packers and distributors named on a marketed prescription drug label must file 15-day 'Alert reports' for serious and unexpected adverse experiences under 21 CFR 310.305; FDA's final guidance (Oct 2015) applies adverse event reporting to 503B outsourcing facilities. FDA notes that federal law does not require state-licensed 503A pharmacies to report adverse events, so compounded-drug events are likely under-reported. Under MoCRA, cosmetic 'responsible persons' must report serious adverse events within 15 business days.

Where FDA enforcement shows up: warning letters, import alerts, recallsFDA posts warning letters in a searchable database, detains risky imports through import alerts (e.g., 66-80 for GLP-1 APIs, 66-41 for unapproved drugs, 80-04 for gloves, 53-21 for adulterated cosmetics), and publishes recalls in its enforcement reports.

Import alerts let FDA detain products without physical examination. Import Alert 66-80 (GLP-1 receptor agonist bulk drug substances) detains semaglutide, tirzepatide, liraglutide, exenatide, orforglipron, retatrutide and dulaglutide APIs unless the manufacturer is on FDA's 'Green List'; FDA cited that 21% of inspected GLP-1 API makers were noncompliant with CGMP. Import Alert 66-41 covers unapproved new drugs promoted in the U.S. and has listed firms offering unapproved botulinum toxin and PT-141 peptide. Recalls, including Class I recalls of compounded glutathione in July–August 2026, appear in FDA enforcement reports and openFDA.

Compounded peptides: where things stand in September 2026FDA pulled 12 peptides out of Category 2 in April 2026 after nominators withdrew them, and its advisory committee voted in July 2026 to recommend six for the 503A bulks list, but none is on the list or in Category 1 yet, so none has federal compounding permission today.

On April 15, 2026 FDA announced that 12 peptides (BPC-157, cathelicidin LL-37, dihexa acetate, emideltide/DSIP, epitalon, GHK-Cu injectable, KPV, PEG-MGF, melanotan II, MOTs-C, Semax, TB-500) would leave Category 2 after seven days because their nominations were withdrawn; FDA's list shows the change effective April 22, 2026. Law-firm analyses stress that leaving Category 2 does not place a substance on the 503A bulks list or in Category 1. At the July 23–24, 2026 PCAC meeting, members voted to recommend BPC-157 (8–6), KPV (8–6), TB-500 (8–6), MOTs-C (7–5), epitalon (7–4) and Semax (8–5), and against emideltide (6–7); FDA staff had recommended against all of them. FDA must still decide and complete notice-and-comment rulemaking. GHK-Cu, dihexa, LL-37, PEG-MGF and melanotan II are slated for a PCAC meeting before the end of February 2027. Earlier, AOD-9604, CJC-1295, ipamorelin, thymosin alpha-1 and Selank left Category 2 in September 2024, and PCAC voted against CJC-1295 and AOD-9604 on Dec 4, 2024.

Search the official databases

FDA

Drugs@FDAApproval status, application number, labels and approval letters for FDA-approved brand and generic drugs.Orange Book: Approved Drug Products with Therapeutic Equivalence EvaluationsTherapeutic-equivalence (AB) ratings, reference listed drugs, patents and exclusivities for approved small-molecule drugs.Purple Book: Database of Licensed Biological ProductsLicensed biologics and their biosimilar and interchangeable products, with exclusivity dates.National Drug Code (NDC) DirectoryThe NDC, labeler, dosage form, marketing category and listing status of a drug product.FDA Drug ShortagesWhether a drug is on FDA's current shortage list, and its status, reason and expected resolution.Registered Outsourcing Facilities (503B)Whether a compounder is a registered 503B outsourcing facility, with its last FDA inspection and any Form 483 or warning letter.Bulk Drug Substances Used in Compounding Under Section 503A (Category 1/2/3 lists)Whether a bulk ingredient (for example a peptide) is in Category 1, 2 or 3 of FDA's interim 503A bulks policy, and links to the final 503A bulks list.503B Bulk Drug Substances ListBulk drug substances that outsourcing facilities may compound from because of clinical need, and substances FDA has placed on or excluded from the list.FDA Warning LettersSearchable warning letters to compounders, telehealth and med-spa sellers, device makers and others, by company, subject and date.FDA Import AlertsProducts and firms that FDA may detain at the border without examination, for example unapproved drugs, peptides and cosmetics.AccessGUDID (Global Unique Device Identification Database)Look up a medical device by UDI or device identifier to see its labeler, model, FDA product code, premarket number and MRI safety status.510(k) Premarket Notification DatabaseWhether a device (for example an aesthetic laser or energy device) was cleared through 510(k), with the K-number, product code and cleared indications.Premarket Approval (PMA) DatabaseClass III devices approved through PMA (for example dermal fillers), with approval orders, supplements and approved indications.MAUDE: Manufacturer and User Facility Device ExperienceReports of adverse events and malfunctions filed for a medical device, by brand, product code or manufacturer.MedWatch Online Voluntary Reporting Form (FDA 3500)Report a serious adverse event, product quality problem or medication error for a drug, biologic, device, compounded product or cosmetic.openFDAPublic APIs and downloads for FDA adverse-event, recall, labeling, NDC, 510(k)/PMA and UDI data.Modernization of Cosmetics Regulation Act of 2022 (MoCRA)Federal cosmetics rules on facility registration, product listing, adverse-event reporting, safety substantiation and labeling, with their compliance dates.Cosmetics Direct (FDA cosmetic registration and listing portal)How cosmetic facilities register and products are listed under MoCRA through FDA's Cosmetics Direct portal.
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Educational summaries of public law and agency guidance, not legal advice. Researched 2026-09-23 from the sources linked on each answer; laws, board rules and FDA policy change, so confirm with the linked agency or your counsel before you rely on an answer. Found something out of date? Tell our compliance desk.