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.


Exosomes & growth-factor products
FDA pathway: Biologic (BLA) required; no approved products
FDA says exosomes used to treat diseases are drugs and biological products needing premarket approval, and there are no FDA-approved exosome products; FDA has sent untitled letters to firms selling exosomes for injection or topical use.
On MedGrid as: Exosomes · Exosome & Growth-Factor Topicals
The federal rules
Exosomes are regulated as drugs and biologicsFDA (Dec 6, 2019): exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products and require premarket review; 'There are currently no FDA-approved exosome products.'
The notice followed serious adverse events in Nebraska patients. FDA's April 2024 consumer alert repeats that no exosome products are approved.
- Public Safety Notification on Exosome Products — FDA/CBER, 2019-12-06
- Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes — FDA/CBER, 2024-04-09
Enforcement against exosome sellers, including topical useFDA's May 7, 2024 untitled letter to Exocel Bio covered 'Exovex' exosome products used 'for injection or topical use' and promoted for conditions such as alopecia, rosacea and pain; a Jan 16, 2024 letter to Vitacell Biologics covered an exosome product sold with umbilical-cord 'stem cells'.
Disease or structure/function claims make exosome topicals drugs/biologics.
- Untitled Letter — Exocel Bio, Inc. — FDA/CBER, 2024-05-07
- Untitled Letter — Vitacell Biologics, LLC — FDA/CBER, 2024-01-16
Cosmetic-only exosome topicals: status not settledWhether a human- or plant-derived 'exosome' skincare product making only appearance claims can be sold as a cosmetic under MoCRA was not confirmed from FDA sources.
Answer: unknown. FDA's drug-vs-cosmetic test is intended use; claims about regeneration, collagen or hair growth are drug claims. Microneedling devices are not approved for delivering such products into the skin.
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) — FDA, 2024-09-11
- Microneedling Devices — FDA, 2025-10-15
Changing now
- CBER's untitled-letter list (updated 07/15/2026) for new exosome actions. — CBER Untitled Letters
What Mississippi adds
Who may inject neuromodulators and fillersNo Mississippi rule or position statement specific to who may inject Botox or fillers was found; the Board of Medical Licensure requires a valid licensee-patient relationship before any prescription.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 Mississippi Board of Nursing's position statement list (checked 2026-09-23) has no statement on cosmetic injectables, and the Board of Medical Licensure's Administrative Code (as amended February 2026) has no cosmetic-injection rule. The BML's IV guidance quotes Rule 1.11 of Part 2640: prescriptions may not be written outside a valid licensee-patient relationship, which includes an appropriate history and physical examination, a diagnosis and informed consent. How that applies to RN-administered neuromodulators and fillers has not been confirmed.
The BML declaratory opinion 'Practice of Medicine by Non-Licensees' (Jan. 2020) is a scanned PDF that could not be read as text. Check with the Board of Nursing and BML.
- Position Statements — Mississippi Board of Nursing, 2026-09-23
- Guidance Regarding IV Hydration Therapy (quotes Part 2640 Rule 1.11) — Mississippi State Board of Medical Licensure, 2023-09-05
State laws on stem cell / regenerative therapiesMississippi's Right to Try law covers adult autologous mesenchymal stem cells for patients with a debilitating disability, traumatic injury, or terminal or life-threatening illness.State-specific law
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)?
SB 2830 (approved June 25, 2020) amended the Right to Try Act (Miss. Code §41-131-1) to include 'adult autologous mesenchymal stem cell' treatments. Eligible patients have a debilitating disability, traumatic injury, terminal illness or life-threatening illness that has not responded to approved products. The treatment must have completed Phase 1 of a clinical trial and remain under investigation, among other listed criteria (an FDA/NIH-approved protocol, IRB approval, or a completed safety study). Written informed consent is required. 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.
Autologous cells only; the law does not cover allogeneic birth-tissue products or exosomes. Statute text accessed via FindLaw (current as of Jan 1, 2025).
Miss. Code Ann. §41-131-1 (SB 2830, 2020)
- Miss. Code Ann. §41-131-1 — Right to Try (adult autologous mesenchymal stem cells) — FindLaw (Mississippi Code), 2025-01-01
- 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 Mississippi-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?
Mississippi 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: Who may inject neuromodulators and fillers · State laws on stem cell / regenerative therapies · State rules for cosmetics and sunscreen
Mississippi at a glance
Every topic we research, for Mississippi. Open any line for the rule, its citation and the source.
Pharmacy & compounding
Out-of-state pharmacies shipping into the stateOut-of-state pharmacies must hold a Mississippi nonresident pharmacy permit, with a Mississippi-licensed pharmacist-in-charge, to serve Mississippi patients.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?
Under Miss. Code §73-21-106 as reenacted by HB 856 (2025), any pharmacy outside Mississippi that performs pharmacy services for Mississippi residents or businesses is a nonresident pharmacy and must be permitted by the Board of Pharmacy. The permit requirement also applies to any nonresident pharmacy that dispenses, distributes or ships prescription drugs directly to consumers in the state. Applicants must keep a valid home-state license and submit the most recent inspection report from their home-state regulator or a Board-approved inspecting entity. The pharmacist-in-charge must hold a Mississippi license as well as a home-state license, and cannot be PIC at any other Board-permitted location. The pharmacy also needs toll-free pharmacist access at least 6 days and 40 hours per week, with the number on labels. Pharmacies that compound also need a Board compounding certificate and must file an annual compounding statistical report (Board Regulations Art. XXXI).
HB 856 (effective on passage; Board says April 23, 2025) widened the nonresident definition to any pharmacy performing pharmacy services for Mississippi residents or businesses, including non-dispensing services. The statute text was read from the enrolled bill because the official code host (LexisNexis) and Justia/Casetext blocked access.
Miss. Code Ann. §73-21-106 (as amended by 2025 HB 856); Miss. Bd. of Pharmacy Regs. Art. VI(1)(D), (2)(D); Art. XXXI(1)(A)
- HB 856, 2025 Regular Session (As Sent to Governor) - reenacts and amends §73-21-106 — Mississippi Legislature, 2025-04-23
- Mississippi Board of Pharmacy Regulations (compiled 4-24-26) — Mississippi Board of Pharmacy, 2026-04-24
- 2025 Legislative Updates for the Mississippi Pharmacy Practice Act (HB 856 summary, eff. April 23, 2025) — Mississippi Board of Pharmacy, 2025-04-23
Office-use compounding from 503A pharmaciesMississippi pharmacies may not supply non-patient-specific compounded human drugs to practitioners; they may compound patient-specific medications for a practitioner to administer in the office.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.
Board Regulations Art. XXXI(1)(E) state: 'Pharmacies shall not offer compounded human drug products to practitioners or to other pharmacies for resale or dispensing,' and allow pharmacies to 'compound patient specific medications for office administration by a practitioner.' Art. XXXI(1)(B) and (D) allow compounding for an individual patient on a valid prescription, or in advance based on a history of prescriptions within an established pharmacist/patient/practitioner relationship. Art. XXXI(1)(G) treats distributing 'inordinate amounts' of compounded products without that relationship as manufacturing. Nonresident permit holders must certify that they will comply with Mississippi pharmacy laws and regulations (§73-21-106(2)(c)).
Possible tension: Art. XXXII(1)(A)(6) says a 503A pharmacy's sales of a 'prescription drug or device' to a practitioner for office use, up to 5% of its annual prescription sales, are not 'wholesale distribution' (so no distributor permit is needed). That definition does not mention compounding, and the compounding-specific Art. XXXI(1)(E) limits compounded human products to patient-specific medications. Confirm with the Board (compliance@mbp.ms.gov) before relying on the 5% language for compounded products. In the 2026 regulations the compounding article is Art. XXXI; the lead's 'Art. XXIV' is now Security of Controlled Substances.
Miss. Bd. of Pharmacy Regs. Art. XXXI(1)(B), (D), (E), (G); Art. XXXII(1)(A)(6)
- Mississippi Board of Pharmacy Regulations (compiled 4-24-26), Art. XXXI Compounding Guidelines — Mississippi Board of Pharmacy, 2026-04-24
503B outsourcing facilities shipping into the stateOut-of-state 503B outsourcing facilities need a Mississippi Sterile Product Outsourcer permit (offered to in-state and out-of-state facilities) before distributing into Mississippi.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?
Mississippi Board Regulations Art. VI(1)(F) and (2)(F) create a 'Sterile Product Outsourcing' permit for compounding and distributing sterile medications 'both in-state and out-of-state in accordance with FDA guidelines.' The facility must hold FDA outsourcing facility registration and follow cGMP. Its pharmacist-in-charge must certify full FDA and DEA compliance, and it may not share a location with a pharmacy permit. The Board's fee schedule lists 'Outsourcer (In-State and Out of State)' at $300, plus $50 for a controlled substance registration if needed. More broadly, Art. XXXII(2) requires every business distributing prescription drugs into Mississippi to register with the Board. Miss. Code §73-21-126, as amended in 2025, directs permits for in- and out-of-state entities 'owning or shipping into' Mississippi.
The Board's facility page lists 'Sterile Product Outsourcer' and 'Non-Resident Facility' applications, but their contents could not be extracted, so inspection-report specifics for nonresident outsourcers were not confirmed. Art. XXXII(3)(D) requires drug-facility permit applicants to submit an inspection from the last 3 years (the most recent FDA inspection has no time limit). A 503B that also dispenses patient-specific prescriptions into Mississippi may also need a nonresident pharmacy permit; check with the Board (licensing@mbp.ms.gov).
Miss. Bd. of Pharmacy Regs. Art. VI(1)(F), (2)(F), (3); Art. XXXII(2); Miss. Code Ann. §73-21-126 (as amended by 2025 HB 856)
- Mississippi Board of Pharmacy Regulations (compiled 4-24-26), Art. VI and Art. XXXII — Mississippi Board of Pharmacy, 2026-04-24
- Applications & Fees (Outsourcer - In-State and Out of State) — Mississippi Board of Pharmacy, 2026-09-23
- HB 856, 2025 Regular Session - amends §73-21-126 — Mississippi Legislature, 2025-04-23
FDA compounding MOUMississippi 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; Mississippi 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 registrationMississippi does not issue a separate state controlled substance certificate to physicians: the Board of Medical Licensure adopts the DEA registration in lieu of a separate state registration, and licensees must also register with the state PMP.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.
Miss. Code 41-29-125 lets the Board of Pharmacy, Board of Medical Licensure, Board of Nursing and others register persons who dispense controlled substances, with a separate registration per principal place of practice. Using that authority, Board of Medical Licensure rule (Part 2640, Chapter 1, Rule 1.3) requires every licensee who prescribes, administers or dispenses controlled substances to be registered with the DEA and with the Mississippi Prescription Monitoring Program, and 'adopts, in lieu of a separate registration with the Board, the registration with the U.S. Drug Enforcement Administration'. PAs are covered by the same in-lieu rule (Part 2615, Rule 1.5).
The statute also names the Mississippi Board of Nursing as a registering authority; whether it imposes its own registration on APRNs was not checked. The Board's dispensing-physician rules (Part 2640, Rule 1.9) apply to physicians who dispense.
Miss. Code Ann. 41-29-125; 30 Miss. Admin. Code Pt. 2640, Ch. 1, R. 1.3; Pt. 2615, R. 1.5
- Mississippi Administrative Code Title 30 - Board of Medical Licensure (Part 2640 Rule 1.3; Part 2615 Rule 1.5) — Mississippi State Board of Medical Licensure, 2026-09-23
- Mississippi Code Sec. 41-29-125 - FindLaw reproduction — FindLaw (text of the Mississippi Code), 2025-01-01
PDMP check before prescribingMississippi requires MPMP checks for most controlled substances (new patients and every 3 months, and every opioid/benzodiazepine encounter), but its rules expressly exempt testosterone prescriptions.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.
Board of Medical Licensure Rule 30-2640-1.3 requires every prescriber to register with the MPMP; pain management practices must review it at every encounter where a controlled substance is prescribed; all licensees must review it at every encounter where an opioid is prescribed for non-cancer pain; and other licensees must use it on initial contact with new patients and at least every 3 months for patients prescribed, administered or dispensed non-opioid controlled substances. The same rule states licensees issuing a prescription for Lomotil, Lyrica, testosterone, pseudoephedrine, or ADHD amphetamines for children under 16 are not required to use the MPMP in that instance; inpatient care is exempt but discharge prescriptions are not. Rule 1.10(H) requires a check for every benzodiazepine prescription. For APRNs, Board of Nursing Rule 30-2840-1.5 requires MPMP use for an initial controlled substance prescription and every opioid/benzodiazepine encounter, and likewise lets the APRN forgo it for testosterone.
Source older than 2 years - possibly stale (Rule 2640-1.3 last amended 10/29/2018; Rule 2840-1.5 amended 7/11/2024). Testosterone (C-III) is expressly carved out for both physicians/PAs and APRNs, though other Schedule III drugs are covered (new patient + every 3 months). Rules read on LII, not the Secretary of State's code site.
30 Miss. Code R. 2640-1.3, 2640-1.7, 2640-1.10(H); 30 Miss. Code R. 2840-1.5
- 30 Miss. Code R. 2640-1.3 - Registration for Controlled Substances Certificate — Legal Information Institute (Mississippi State Board of Medical Licensure rule text), 2018-10-29
- 30 Miss. Code R. 2640-1.10 - Prescription Guidelines - Controlled Substances — Legal Information Institute (Mississippi State Board of Medical Licensure rule text), 2018-10-29
- 30 Miss. Code R. 2840-1.5 - Prescribing Controlled Substances and Medications by APRNs — Legal Information Institute (Mississippi Board of Nursing rule text), 2024-07-11
Physicians dispensing from the officeMississippi physicians reportedly must register with the Board of Medical Licensure as dispensing physicians and complete dispensing CME before dispensing.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.
A vendor summary reports that Mississippi physicians must register with the Mississippi State Board of Medical Licensure as dispensing physicians, complete at least 10 hours of Category 1 CME in pharmacology or medication dispensing beforehand, personally dispense (no delegation), and report dispensed controlled substances to the Mississippi PMP within 24 hours or the next business day. The board rule text was not reviewed.
Board rule not located by the research tools; confirm with the Mississippi State Board of Medical Licensure.
Mississippi State Board of Medical Licensure rules (Title 30, Part 2640) - not verified
- Mississippi Physician Dispensing Laws & Regulations — PharmaLink (vendor summary), 2026-09-23
- Mississippi State Board of Medical Licensure — Mississippi State Board of Medical Licensure, 2026-09-23
Prescribing by telehealthMississippi allows prescribing after an appropriate exam in person or by telemedicine, but its controlled-substance statute requires an in-person evaluation unless telemedicine prescribing is authorized under state or federal law.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.
A Mississippi-licensed practitioner may prescribe after an appropriate examination in person or through telemedicine instrumentation (Miss. Code 41-127-1). For controlled substances, a 'valid prescription' requires at least one in-person medical evaluation, except as authorized by Section 41-29-137.1 or for a practitioner engaged in telemedicine as authorized under state or federal law; a controlled-substance prescription based only on an online questionnaire is invalid (Miss. Code 41-29-137). How the telemedicine exception applies to testosterone should be confirmed with the Mississippi State Board of Medical Licensure. IMLC: member.
Board telemedicine rules were not read.
Miss. Code 41-127-1; Miss. Code 41-29-137
- Mississippi - Professional Requirements — Center for Connected Health Policy (CCHP), 2026-07-11
- 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 Mississippi rule or position statement specific to who may inject Botox or fillers was found; the Board of Medical Licensure requires a valid licensee-patient relationship before any prescription.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 Mississippi Board of Nursing's position statement list (checked 2026-09-23) has no statement on cosmetic injectables, and the Board of Medical Licensure's Administrative Code (as amended February 2026) has no cosmetic-injection rule. The BML's IV guidance quotes Rule 1.11 of Part 2640: prescriptions may not be written outside a valid licensee-patient relationship, which includes an appropriate history and physical examination, a diagnosis and informed consent. How that applies to RN-administered neuromodulators and fillers has not been confirmed.
The BML declaratory opinion 'Practice of Medicine by Non-Licensees' (Jan. 2020) is a scanned PDF that could not be read as text. Check with the Board of Nursing and BML.
- Position Statements — Mississippi Board of Nursing, 2026-09-23
- Guidance Regarding IV Hydration Therapy (quotes Part 2640 Rule 1.11) — Mississippi State Board of Medical Licensure, 2023-09-05
IV hydration and vitamin therapyMississippi requires a physician, NP or PA to complete a history and physical and write an individualized order before a nurse gives IV hydration; standing orders are not an acceptable substitute, and nurses may not compound.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?
The Board of Nursing's IV Hydration position statement (April 2025, updated 2025-10-10) covers mobile units and wellness clinics: RNs may administer prescribed IV hydration, nutrient therapies and medications only with a valid individualized order and a completed history and physical by a physician, NP or PA; standing orders are not acceptable substitutes; LPNs may assist under RN/prescriber supervision; businesses must keep on-site policies and emergency procedures; and compounding is outside RN, APRN and LPN scope. The Board of Medical Licensure's 2023 guidance adds that IV fluids are legend drugs bought under a practitioner's DEA number, that a prescriber must establish the relationship, take a history, diagnose and prescribe for a specific patient, and that acting as a 'medical director' relying on standing orders is unprofessional conduct.
MSBN IV Hydration Position Statement (orig. 2025-04-11, updated 2025-10-10); MSBML Guidance Regarding IV Hydration Therapy (2023-09-05); Miss. Code Ann. §§73-25-29, 73-25-33; MSBML Part 2640 Rule 1.11
- IV Hydration Position Statement (updated October 2025) — Mississippi Board of Nursing, 2025-10-10
- Guidance Regarding IV Hydration Therapy — Mississippi State Board of Medical Licensure, 2023-09-05
Corporate practice of medicine / med spa ownershipMississippi's medical board says it does not police the business form of a physician's practice as long as the physician keeps sole control of treatment and billing, but older case law leaves the doctrine unclear.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?
Board Policy 3.02 (policies as revised December 2025) states the Board will not concern itself with the form or type of business arrangement a licensee enters into, provided the physician is Board-licensed, treatment decisions and billing are left to the physician's sole discretion free of influence, and there are no referral inducements or anti-kickback violations. Permit Health nonetheless rates Mississippi 'Mixed/Unclear', citing optometry-era cases (Sears Roebuck v. State Bd. of Optometry, 1952; Busch Jewelry, 1953) alongside Policy 3.02.
Policy compilation dated 'as last revised December 2025' (recorded as 2025-12-01).
MSBML Board Policy 3.02 'Corporate Practice of Medicine'
- MSBML Board Policies (Policy 3.02 Corporate Practice of Medicine) — Mississippi State Board of Medical Licensure, 2025-12-01
- The Corporate Practice of Medicine 50-State Guide — Permit Health, 2025-12-23
Who may operate aesthetic lasersMississippi limits cosmetic laser and pulsed-light use to physicians and people they directly supervise, with the physician on the premises and able to step in.Delegable with licensing/training rules
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?
Board of Medical Licensure Rule 3.1 (Part 2635, Chapter 3) says use of laser, pulsed light or similar devices, for invasive or cosmetic procedures, is the practice of medicine and is limited to physicians and those directly supervised by physicians, such that a physician is on the premises and would be directly involved in treatment if required. Dentists using lasers solely for dentistry are exempt. The rule does not limit which staff may be supervised, but requires on-site physician presence.
Code compilation 'as last amended February 2026' (recorded as 2026-02-01); Rule 3.1 itself last amended 2008.
Miss. Admin. Code Title 30, Part 2635, Ch. 3, Rule 3.1 (last amended 2008-03-27)
- MSBML Administrative Code, Title 30 Parts 2601–2650 (Rule 3.1 Laser Devices) — Mississippi State Board of Medical Licensure, 2026-02-01
Labs, regenerative medicine & cosmetics
State clinical laboratory licensing (beyond CLIA)Not confirmed. No Mississippi 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). Mississippi was not among them, but this research did not confirm its statutes. Mississippi's CLIA state agency is Mississippi State Dept. of Health, Licensure and Certification/CLIA (CLIA-MSDH@msdh.ms.gov, 601-364-1115); 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 Mississippi 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 Mississippi's rule. Mississippi's lab regulator (CLIA state agency) is Mississippi State Dept. of Health, Licensure and Certification/CLIA (CLIA-MSDH@msdh.ms.gov, 601-364-1115). 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 therapiesMississippi's Right to Try law covers adult autologous mesenchymal stem cells for patients with a debilitating disability, traumatic injury, or terminal or life-threatening illness.State-specific law
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)?
SB 2830 (approved June 25, 2020) amended the Right to Try Act (Miss. Code §41-131-1) to include 'adult autologous mesenchymal stem cell' treatments. Eligible patients have a debilitating disability, traumatic injury, terminal illness or life-threatening illness that has not responded to approved products. The treatment must have completed Phase 1 of a clinical trial and remain under investigation, among other listed criteria (an FDA/NIH-approved protocol, IRB approval, or a completed safety study). Written informed consent is required. 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.
Autologous cells only; the law does not cover allogeneic birth-tissue products or exosomes. Statute text accessed via FindLaw (current as of Jan 1, 2025).
Miss. Code Ann. §41-131-1 (SB 2830, 2020)
- Miss. Code Ann. §41-131-1 — Right to Try (adult autologous mesenchymal stem cells) — FindLaw (Mississippi Code), 2025-01-01
- 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 Mississippi-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?
Mississippi 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
FDA compounding MOU. 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).
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
Search the official databases
FDA
DEA
Registries & compacts
Every vendor on MedGrid clears document review for its category before it lists. Join free with your NPI to see wholesale pricing.
Platform terms — non-circumvention
Non-circumvention. Every introduction made through MedGrid — doctor to vendor, doctor to pharmacy, vendor to pharmacy, partner to any of them — is platform-protected. For 24 months following an introduction, the parties agree not to solicit, contract, or transact directly (or through affiliates) in a manner that circumvents MedGrid or its fees. Renewals, refills, and reorders of platform-introduced relationships run through the platform. This clause is part of every participant agreement — doctor, vendor, pharmacy, and sales partner alike — and it protects the people who make the introductions as much as it protects MedGrid.
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.
