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.


FDA records for “testosterone”
Searching FDA approvals, shortages, recalls and device records…
Syringes & needles
FDA pathway: Device class II (510(k))
Piston syringes and hypodermic needles are Class II devices with performance standards; OSHA requires employers to use and annually evaluate safety-engineered sharps.
On MedGrid as: Syringes & Needles · Injection Supplies
The federal rules
Device classificationPiston syringes (21 CFR 880.5860) and hypodermic single-lumen needles (880.5570) are Class II; antistick (safety) syringes are product code MEG, Class II, 510(k).
Verify a product's 510(k) and UDI before purchase.
- 21 CFR 880.5860 — Piston syringe — eCFR, 2026-09-01
- 21 CFR 880.5570 — Hypodermic single lumen needle — eCFR, 2026-09-01
- openFDA device classification: FMF, FMI, MEG — FDA (openFDA), 2026-09-23
OSHA safety-engineered sharpsOSHA's Bloodborne Pathogens standard requires the exposure control plan to document, at least annually, consideration and implementation of commercially available safer medical devices, with input from front-line staff.
It defines 'sharps with engineered sharps injury protections' and 'needleless systems'. These requirements were added by the Needlestick Safety and Prevention Act of 2000 (statute not separately retrieved).
- 29 CFR 1910.1030 — Bloodborne pathogens — eCFR, 2026-09-01
Changing now
- FDA device recalls and safety communications for syringes (check MAUDE and recalls). — MAUDE
What Missouri adds
No state-specific topics apply to this category beyond the federal rules.
Look it up yourself
Missouri at a glance
Every topic we research, for Missouri. Open any line for the rule, its citation and the source.
Pharmacy & compounding
Out-of-state pharmacies shipping into the stateAn out-of-state pharmacy must hold a Missouri Board of Pharmacy pharmacy permit before shipping, mailing or delivering prescription drugs into Missouri; the pharmacist in charge may be licensed in Missouri or in the home state.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?
20 CSR 2220-2.025(1) bars nonresident pharmacies from shipping, mailing or delivering prescription drugs into Missouri without a Missouri pharmacy license. There are two exceptions: emergencies, and refills of a prescription first filled and delivered in the pharmacy's home state. The applicant needs a home-state pharmacy license in good standing. Its pharmacist in charge must hold either a Missouri license or an active license in the home state, with an official verification if not Missouri-licensed. If it ships controlled substances, it must file its DEA and state controlled-substance registrations. It must also file its most recent home-state inspection: within 18 months for sterile compounding applicants and 24 months for all others. If no state inspection is available, the Board may accept its own inspection, an NABP Verified Pharmacy Program (VPP) inspection, or one by another Board-approved entity. The permit lists each class of pharmacy practiced, such as Class D non-sterile compounding or Class H sterile compounding (20 CSR 2220-2.020(9)–(10)). RSMo §338.220 makes it unlawful to operate any pharmacy without a Board permit.
The rule was last amended effective 4/30/2018 and is still in force according to the Board's 2025 Practice Guide and current application list. The Board's forms page lists a 'Pharmacy Permit Application (Non-resident facility)'. The official Secretary of State CSR PDF blocked fetching, so the LII copy was used. Correction to the lead: 'Class R' is the Remote Dispensing Site Pharmacy permit (RSMo §338.215, §338.220(18)), not a nonresident credential. Change: the sterile compounding rule 20 CSR 2220-2.200 was revised effective 7/30/2026 to adopt USP <797> (2023), and it applies to all Class H sterile compounding permit holders.
20 CSR 2220-2.025; 20 CSR 2220-2.020(9)–(10); RSMo §338.220
- 20 CSR 2220-2.025 — Nonresident Pharmacies — Legal Information Institute (copy of Missouri Code of State Regulations), 2018-04-30
- 2025 Missouri Pharmacy Practice Guide, §D.3–D.5 (Non-Resident Pharmacies; Pharmacist-in-Charge) — Missouri Board of Pharmacy, 2026-09-23
- RSMo §338.220 — Operation of pharmacy without permit or license unlawful; permit classes — Missouri Revisor of Statutes, 2020-08-28
Office-use compounding from 503A pharmaciesMissouri bars pharmacies from supplying compounded preparations to practitioners for human office stock; only a Missouri-licensed 503B 'drug outsourcer' may supply office use.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.
20 CSR 2220-2.400(12) provides that 'pharmacists shall not offer or provide compounded preparations to other pharmacies, practitioners, or entities for subsequent dispensing, distribution, resale, or administration,' except for a prescriber to give to an individual patient on a prescription the pharmacy dispensed. Rule 2.400(10) prohibits compounding without a prescription or medication order. The Board's 2025 Practice Guide says compounded preparations may not be offered to practitioners for office use. A pharmacy may, however, dispense a patient-specific compounded preparation for the prescriber to administer in the office. An FDA-registered 503B facility may supply office-use preparations if it is licensed as a Missouri drug outsourcer. The only non-patient-specific exceptions are veterinary office stock for Missouri-licensed veterinarians (2.400(13)) and a drug-shortage exception for Class B hospital pharmacies. This matches FDA's patient-specific view of 503A.
Rule 2.400 was last amended effective 9/30/2023. It also bars compounding essentially copies of commercially available products unless the prescriber documents a patient-specific medical need or clinically significant difference (2.400(9)). Pharmacists may use only drug substances made or distributed by Missouri-licensed or registered drug distributors (2.400(6)(B)). The Board revised its sterile compounding rule (20 CSR 2220-2.200) effective 7/30/2026 but did not revise rule 2.400. Stale-source flag: the controlling text is dated 2023-09-30 (more than 2 years before 2026-09-23); it is the latest version found, but confirm with the board that it is still current.
20 CSR 2220-2.400(10), (12), (13)
- 20 CSR 2220-2.400 — Compounding Standards of Practice — Legal Information Institute (copy of Missouri Code of State Regulations), 2023-09-30
- 2025 Missouri Pharmacy Practice Guide, §H.22 (Office Stock Dispensing) and §I.2 (Compounding for Office Use) — Missouri Board of Pharmacy, 2026-09-23
503B outsourcing facilities shipping into the stateAn out-of-state 503B outsourcing facility must hold a Missouri 'drug outsourcer' license from the Missouri Board of Pharmacy before selling or distributing drugs in Missouri.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?
RSMo §338.330(1) defines a 'drug outsourcer' as an outsourcing facility under 21 U.S.C. §353b. §338.333 bars acting as a drug outsourcer without a Board license. §338.337 makes it unlawful for an out-of-state drug outsourcer to do business in Missouri without a license. §338.340 bars anyone acting for an out-of-state drug outsourcer from selling or distributing drugs in Missouri unless the outsourcer is licensed. The Board's Drug Outsourcer Application (resident and nonresident) requires: FDA 503B registration; the most recent FDA 503B inspection report, if available; a home-state outsourcer license or equivalent (facilities without one are not eligible); a home-state inspection within the last 18 months; a notarized supervising-pharmacist statement, with a license verification if that pharmacist is not Missouri-licensed; and a $360 fee. The Board's Practice Guide says a licensed Missouri drug outsourcer may supply compounded preparations to providers for office use.
§338.333 was amended by 2026 H.B. 2372 / S.B. 1233, effective 8/28/2026, per the Revisor's history. The specific changes were not itemized here. The current text lets the Board make exceptions by rule for emergencies or supply shortages and allows reciprocity licensing of out-of-state outsourcers. The outsourcer application form is undated. The drug outsourcer category dates to 2018 H.B. 1719.
RSMo §§338.330(1), 338.333, 338.337, 338.340
- RSMo §338.333 — License required; out-of-state distributors; reciprocity (effective 28 Aug 2026) — Missouri Revisor of Statutes, 2026-08-28
- RSMo §338.337 — Out-of-state distributors, licenses required — Missouri Revisor of Statutes, 2018-08-28
- Missouri Drug Outsourcer Application (Resident & Non-Resident) and Instructions — Missouri Board of Pharmacy, 2026-09-23
FDA compounding MOUMissouri 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; Missouri 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))
- Compounding MOUs (list of signed standard MOUs) — U.S. Food and Drug Administration, 2023-01-23
- Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs — U.S. Food and Drug Administration, 2022-10-20
- Compounding Information for States — U.S. Food and Drug Administration, 2026-08-28
- Federal Register 87 FR 63770 (Oct. 21, 2022), Doc. 2022-22876 — MOU suspension and extension of 5% enforcement period — Federal Register / GovInfo, 2022-10-21
Prescribing, dispensing & telehealth
State controlled-substance registrationMissouri requires practitioners to hold a Missouri controlled substance registration from the DHSS Bureau of Narcotics and Dangerous Drugs (BNDD) before prescribing, administering, dispensing or stocking controlled substances, and then a DEA registration.State CS registration required
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.
RSMo 195.030.2 prohibits anyone from dispensing or prescribing any controlled substance without first obtaining a registration from the Department of Health and Senior Services, and no registration may be granted for more than three years. BNDD's FAQ states that any person in Missouri conducting controlled-substance activities (prescribing, administering, dispensing, stocking) needs a registration, and that a person needs the professional license, then the BNDD registration, then the federal DEA registration. Most practitioners hold one registration at their primary Missouri practice location and may prescribe elsewhere, but a separate registration is required at each location where controlled substances are stocked and stored; a registration terminates if an address change is not reported within 30 days.
Fee and exact cycle were not shown on the pages opened (statute caps the term at 3 years). Applies to mid-level practitioners (APRNs, PAs) with delegated CS authority as well. Per-location: separate registration where controlled substances are stocked.
RSMo 195.030
- RSMo 195.030 - Rules, fees, registration required — Missouri Revisor of Statutes, 2026-09-23
- Narcotics & Dangerous Drugs FAQ — Missouri Department of Health and Senior Services - BNDD, 2026-09-23
PDMP check before prescribingMissouri law does not require prescribers to check the new statewide PDMP; the program's FAQ says only that the federal SUPPORT Act requires a check before prescribing controlled substances to MO HealthNet (Medicaid) participants, and opioid treatment programs must use it.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.
RSMo 195.600 (enacted 2021 by S.B. 63) created the statewide PDMP run by the Joint Oversight Task Force for Prescription Drug Monitoring; it requires pharmacies to report Schedule II-IV dispensations and permits prescribers and dispensers to access data, but contains no duty to query. The official Missouri PDMP FAQ states that Missouri law does not mandate providers to check the PDMP before writing or dispensing a prescription, but that the federal SUPPORT Act requires prescribers to check before prescribing a Schedule II, III or IV controlled substance to a MO HealthNet participant. Separately, 9 CSR 30-3.132 requires physicians and staff of certified opioid treatment programs to register with and use a PDMP where available. For a non-Medicaid testosterone patient in an ordinary practice there is no state query mandate.
The FAQ describes the SUPPORT Act requirement as covering Schedule II-IV for MO HealthNet participants; Oregon's Medicaid rule citing the same federal statute (42 U.S.C. 1396w-3a) applies it to Schedule II only, so the scope for Medicaid patients should be confirmed with MO HealthNet. RSMo 195.600 bars interstate data sharing (per FAQ). Statute effective Aug 28, 2021 (source older than 2 years but current per the Revisor site). The PDMP site links rules at 1 CSR 60-1 (not opened).
RSMo 195.600; 9 CSR 30-3.132; SUPPORT Act (42 U.S.C. 1396w-3a) as described by the Missouri PDMP
- RSMo 195.600 - Joint Oversight Task Force for Prescription Drug Monitoring — Missouri Revisor of Statutes, 2021-08-28
- Missouri PDMP - Frequently Asked Questions — Missouri Prescription Drug Monitoring Program (Joint Oversight Task Force), 2026-09-23
- 9 CSR 30-3.132 - Opioid Treatment Programs — Legal Information Institute (reproducing Missouri Code of State Regulations, Dept. of Mental Health), 2021-12-30
Physicians dispensing from the officeMissouri physicians may dispense to established patients without a separate permit, following Board of Healing Arts labeling, records, presence and freedom-of-choice rules.Allowed
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.
20 CSR 2150-5.020 (Nonpharmacy Dispensing) lets physicians dispense only to patients with whom they have a physician-patient relationship. A physician may not require patients to get drugs only from the office, must generally be present when dispensing occurs (or a PA or collaborative-practice nurse must be), must label drugs with date, patient, directions, physician name and address and drug name and strength, and must keep records. The rule states no registration requirement. Dispensed Schedule II-IV drugs are reportable to Missouri's statewide PDMP (reporting began January 1, 2024 per a vendor summary).
Rule effective January 30, 2010 and still in force at access; source older than 2 years.
20 CSR 2150-5.020
- 20 CSR 2150-5.020 - Nonpharmacy Dispensing — Legal Information Institute (Missouri Code of State Regulations), 2010-01-30
- Missouri Physician Dispensing Laws & Regulations — PharmaLink (vendor summary), 2026-09-06
Prescribing by telehealthMissouri requires a Missouri (or IMLC) license, and a 2026 amendment (effective 8/28/2026) bars prescribing based solely on a telemedicine evaluation unless a previously established, ongoing physician-patient relationship exists, which on its face reaches first-visit telehealth prescribing of Schedule III drugs.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.
(1) Providers treating patients in Missouri by telehealth must be fully licensed in Missouri; exemptions cover informal or episodic consultation and uncompensated emergency care (RSMo 191.1145). (2) A relationship may be established by a telemedicine encounter if the standard of care does not require in-person care, with an evaluation, history and an exam sufficient for diagnosis; a questionnaire may support the relationship only if it yields in-person-equivalent information, the provider is employed by or contracted with an entity licensed to provide health care in Missouri, and a report goes to the patient's primary care provider within 14 days (RSMo 191.1146, eff. 8/28/2026). (3) As amended by HB 2372, RSMo 334.108.3 prohibits prescribing any drug or controlled substance 'based solely on an evaluation through telemedicine' unless a previously established and ongoing physician-patient relationship exists (the prior text said 'over the telephone'); read literally this reaches Schedule III drugs such as testosterone for new telehealth-only patients, and no Board of Registration for the Healing Arts guidance reconciling it with RSMo 191.1146 was found. (4) IMLC: member.
Least certain entry. HB 2372 (2026, eff. 8/28/2026) changed RSMo 334.108.3 from 'based solely on an evaluation over the telephone' to 'based solely on an evaluation through telemedicine' while the same bill loosened RSMo 191.1146 (physical exam only if the standard of care requires it; questionnaires allowed with conditions). The House bill summary describes the bill as loosening and does not mention the 334.108.3 wording change. How the Board of Registration for the Healing Arts (https://pr.mo.gov/healingarts.asp) will read the two sections together is unknown. Before 8/28/2026 this entry would have been 'yes'.
RSMo 191.1145 (eff. 8/28/2025); RSMo 191.1146 (eff. 8/28/2026); RSMo 334.108 (eff. 8/28/2026, HB 2372 (2026))
- RSMo 334.108 - Telemedicine or internet prescriptions and treatment (effective 8/28/2026) — Missouri Revisor of Statutes, 2026-08-28
- RSMo 334.108 - prior version (effective 8/28/2019 to 8/28/2026) — Missouri Revisor of Statutes, 2019-08-28
- RSMo 191.1146 - Physician-patient relationship required, how established — Missouri Revisor of Statutes, 2026-08-28
- RSMo 191.1145 - Definitions; telehealth services authorized — Missouri Revisor of Statutes, 2025-08-28
- SS SCS HCS HB 2372 (2026) - Health Care, bill summary (Telehealth, Sections 191.1146 and 334.108) — Missouri House of Representatives, 2026-09-23
- IMLC Commission - Compact State Map (participating states) — Interstate Medical Licensure Compact Commission, 2026-09-23
Aesthetics, IV therapy & practice ownership
Who may inject neuromodulators and fillersNo Missouri rule or board statement on who may inject Botox or fillers was found; check with the Missouri State Board of Nursing.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 Missouri State Board of Nursing'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.
The Board's position-statement page (pr.mo.gov/nursing-focus-position.asp) lists no aesthetics statement.
- Missouri State Board of Nursing — Missouri State Board of Nursing, 2026-09-23
IV hydration and vitamin therapyNo Missouri rule or board statement specific to elective IV hydration was found; check with the Missouri State Board of Nursing.Not confirmed
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 Missouri State Board of Nursing's website was checked on 2026-09-23 for guidance on IV hydration clinics (prior exams, standing orders, mobile services) and none was found.
- Missouri State Board of Nursing — Missouri State Board of Nursing, 2026-09-23
Corporate practice of medicine / med spa ownershipCompilations list Missouri as a state without a meaningful corporate practice of medicine bar.No meaningful CPOM
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 lists Missouri as permitted, citing State ex rel. Sager v. Lewin (Mo. Ct. App. 1907) and a 1962 Attorney General opinion; MedPath Compliance (reviewed 2026-06-20) also lists Missouri as 'No'.
State ex rel. Sager v. Lewin (Mo. Ct. App. 1907) (as reported by Permit Health)
- The Corporate Practice of Medicine 50-State Guide — Permit Health, 2025-12-23
- Corporate Practice of Medicine (CPOM) Across the 50 States and D.C. — MedPath Compliance Group, 2026-06-20
Who may operate aesthetic lasersNo Missouri rule on who may operate cosmetic lasers was confirmed; check with the Missouri State Board of Registration for the Healing Arts.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?
No Missouri statute, rule or board policy on delegation of cosmetic laser/IPL procedures or a laser-operator credential was located on 2026-09-23.
- Missouri State Board of Registration for the Healing Arts — Missouri State Board of Registration for the Healing Arts, 2026-09-23
Labs, regenerative medicine & cosmetics
State clinical laboratory licensing (beyond CLIA)Not confirmed. No Missouri 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). Missouri was not among them, but this research did not confirm its statutes. Missouri's CLIA state agency is Missouri DHSS, Bureau of Diagnostic Services, CLIA Laboratory Program (CLIA@health.mo.gov, 573-751-6318); 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
- CLIA State Agency Contacts (updated May 2026) — Centers for Medicare & Medicaid Services, 2026-05-01
Direct-to-consumer lab testingNot confirmed whether Missouri 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 Missouri's rule. Missouri's lab regulator (CLIA state agency) is Missouri DHSS, Bureau of Diagnostic Services, CLIA Laboratory Program (CLIA@health.mo.gov, 573-751-6318). 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).
Not confirmed
- Direct-to-consumer laboratory testing (position statement, 2019): '37 states and the District of Columbia permit consumers to order some or all of their laboratory tests directly' — Association for Diagnostics & Laboratory Medicine (formerly AACC), 2026-09-23
- CLIA State Agency Contacts (updated May 2026) — Centers for Medicare & Medicaid Services, 2026-05-01
State laws on stem cell / regenerative therapiesNo Missouri 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. Missouri 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.
None found
- State Stem Cell Laws: Accurate 2026 Map Update (lists 12 states with statutes; commercial source) — SaveMyFat, 2026-08-06
- U.S. State Laws on Medical Freedom and Investigational Stem Cell Procedures: A call to focus on state-based legislation (Cytotherapy) — Cytotherapy / PubMed Central, 2024-02-03
State rules for cosmetics and sunscreenNo Missouri-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?
Missouri 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
- PFAS in Cosmetics: US State Bans and Compliance Deadlines - 2026 Update — Adherent (formerly Compliance & Risks), 2026-03-13
- State PFAS Bans in Cosmetics Expand Ahead of 2026 (updated Jan. 14, 2026) — Morgan, Lewis & Bockius LLP, 2026-01-14
- Testing cosmetics on animals (US state bans 'as of 2023') — Wikipedia, 2026-09-23
Compare every state
State controlled-substance registration. 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 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).
- Prescription Requirement Under Section 503A of the FD&C Act — Guidance for Industry — FDA/CDER, 2016-12-01
- Registered Outsourcing Facilities — FDA, 2026-09-08
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (503A adverse events not required to be reported) — FDA, 2026-09-01
'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.
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A — Guidance for Industry — FDA/CDER, 2018-01-01
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B — Guidance for Industry — FDA/CDER, 2018-01-01
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.
- Prohibition on Wholesaling Under Section 503B of the FD&C Act — Draft Guidance for Industry — FDA/CDER, 2023-06-27
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.
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1–3) — FDA, 2026-05-14
- Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act — FDA, 2026-05-14
- Safety Risks Associated with Certain Bulk Drug Substances for Use in Compounding (Category 2) — FDA, 2026-04-22
- 503B Bulk Drug Substances List — FDA, 2024-05-16
- Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act — FDA, 2025-01-07
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's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss — FDA, 2026-09-01
- Warning Letter: Gram Peptides (MARCS-CMS 721806) — FDA, 2026-03-31
- Warning Letter: Wholesale Peptide (MARCS-CMS 729447) — FDA, 2026-06-17
- Warning Letter: Royal Peptides LLC (MARCS-CMS 734884) — FDA, 2026-08-24
- Import Alert 66-41: Detention Without Physical Examination of Unapproved New Drugs Promoted in the U.S. — FDA, 2026-09-11
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).
- Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs — FDA, 2022-10-20
- Extension of the Period Before FDA Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-State Distribution of Compounded Human Drug Products (87 FR, Oct 21, 2022) — Federal Register, 2022-10-21
- Unified Agenda, RIN 0910-AI71: Distribution of Compounded Drug Products Under Section 503A (Fall 2025) — OMB/OIRA, 2025-10-01
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.
- Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 90 FR 61301 (Federal Register API record: effective Jan 1 – Dec 31, 2026) — DEA/HHS, Federal Register, 2025-12-31
- Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (FR Doc. 2025-24123) — DEA/HHS, Federal Register, 2025-12-31
- Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for VA Patients — effective Dec 31, 2025, 90 FR 13410 (API record) — DEA/HHS, Federal Register, 2025-03-24
- DEA and HHS Extend Telemedicine Prescribing Flexibilities Through 2026 — Holland & Knight, 2026-01-13
- DEA Prescribing of Controlled Substances (tracker) — Alliance for Connected Care, 2026-08-26
- Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for VA Patients — delay of effective date (FR Doc. 2025-05007) — DEA/HHS, Federal Register, 2025-03-24
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.
- Health Products Compliance Guidance — Federal Trade Commission, 2022-12-01
- FDA to Telehealth Companies: What to Know When Promoting Compounded Drugs — FDA, 2026-06-15
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.
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program — FDA, 2026-09-21
- Adverse Event Reporting for Outsourcing Facilities Under Section 503B — Guidance for Industry — FDA/CDER, 2015-10-01
- 21 CFR 310.305 — Records and reports concerning adverse drug experiences on marketed prescription drugs — eCFR, 2026-09-01
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — FDA, 2026-08-10
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.
- FDA Warning Letters (searchable database) — FDA, 2026-09-23
- Import Alert 66-80: GLP-1 Receptor Agonist Bulk Drug Substances (Green List) — FDA, 2026-09-21
- Import Alert 66-41: Unapproved New Drugs Promoted in the U.S. — FDA, 2026-09-11
- openFDA drug enforcement (recall) query: sterile water / glutathione recalls 2023–2026 — FDA (openFDA), 2026-09-16
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.
- Safety Risks Associated with Certain Bulk Drug Substances for Use in Compounding (Category 2; withdrawn list) — FDA, 2026-04-22
- July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee — FDA, 2026-08-06
- Bulk-list bound? PCAC backs majority of peptides in two-day public meeting — McDermott (law firm), 2026-07-27
- FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings — Orrick, 2026-04-16
- FDA to Remove 12 Popular Peptides from the Category 2 'Do Not Compound' List — Frier Levitt, 2026-09-23
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1–3) — FDA, 2026-05-14
- Pharmacy Compounding Advisory Committee; Notice of Meeting (July 23–24, 2026; 503A bulks nominations), 91 FR 20465 — FDA, Federal Register, 2026-04-16
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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.
