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.


Neuromodulators (botulinum toxins)
FDA pathway: Biologic (BLA)
Seven botulinum toxin BLAs appear in Drugs@FDA, all prescription-only; toxins cannot be compounded, and FDA/CDC warned in 2024 about counterfeit Botox causing hospitalizations.
On MedGrid as: Neuromodulators
The federal rules
FDA-licensed botulinum toxinsDrugs@FDA lists Botox and Botox Cosmetic (onabotulinumtoxinA, BLA 103000), Dysport (abobotulinumtoxinA, BLA 125274, 2009), Xeomin (incobotulinumtoxinA, BLA 125360, 2010), Myobloc (rimabotulinumtoxinB, BLA 103846, 2000), Jeuveau (prabotulinumtoxinA-xvfs, BLA 761085, 2019), Daxxify (daxibotulinumtoxinA-lanm, BLA 761127, 2022) and Letybo (letibotulinumtoxinA-wlbg, BLA 761225, Feb 29, 2024).
All are marked 'Prescription'. Units are product-specific and not interchangeable between brands. Any newer approval (after openFDA's 2026-09-22 refresh) would appear in the Purple Book.
- openFDA Drugs@FDA query: botulinum toxin A products — FDA (openFDA), 2026-09-22
- openFDA Drugs@FDA query: botulinum toxin B (Myobloc) — FDA (openFDA), 2026-09-22
Counterfeit Botox (2024)FDA (Apr 16, 2024; updated May 1, 2024) reported counterfeit Botox found in multiple states and given for cosmetic use, with hospitalizations for blurred vision, trouble swallowing, weakness and breathing problems; FDA worked with CDC and states.
Red flags FDA listed: lot C3709C3, labels reading 'Botulinum Toxin Type A' instead of 'OnabotulinumtoxinA', 150-unit vials, non-English packaging. FDA says products from unlicensed sources may be counterfeit, contaminated or ineffective.
- Counterfeit Version of Botox Found in Multiple States — FDA, 2024-05-02
Biologic: no compounding; imports of unapproved toxins detainedBotulinum toxins are licensed biologics outside the 503A/503B exemptions; Import Alert 66-41 has listed foreign firms offering unapproved botulinum toxin products.
Only FDA-licensed, U.S.-labeled product through the authorized supply chain is legal to administer.
- Notice to compounders: changes that affect compounding as of March 23, 2020 — FDA, 2020-03-05
- Import Alert 66-41 — FDA, 2026-09-11
Changing now
- New toxin approvals (e.g., relabotulinumtoxinA) were not found in openFDA as of 2026-09-22; confirm in the Purple Book. — openFDA Drugs@FDA query: botulinum toxin products
What Washington DC adds
Physicians dispensing from the officeD.C. pharmacy law exempts a licensed practitioner who personally dispenses drugs to the practitioner's own patients.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.
D.C. Code 47-2885.01(b)(1) exempts from the pharmacy act a duly licensed medical practitioner who personally dispenses or administers drugs as the practitioner deems proper in treating the practitioner's patients. No separate dispensing permit was found in the statute. Controlled substances require a D.C. controlled substance registration and DEA registration.
D.C. Code 47-2885.01(b)(1)
- D.C. Code 47-2885.01. Purposes; scope — Council of the District of Columbia, 2026-09-23
Who may inject neuromodulators and fillersNo District of Columbia rule or board statement on who may inject Botox or fillers was found; check with the DC Board of Nursing (DC Health).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 DC Board of Nursing (DC Health)'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.
- DC Board of Nursing (DC Health) — DC Board of Nursing (DC Health), 2026-09-23
Corporate practice of medicine / med spa ownershipCompilations describe DC's corporate practice of medicine rule as moderate and based on statute and case law.CPOM with exceptions
Does the state enforce the corporate practice of medicine doctrine (non-physicians may not own medical practices or employ physicians), and how does that affect med spa ownership?
Permit Health's 2025 guide rates DC 'Moderate (Common Law)', citing D.C. Code §§3-1201.02(7)(A), 29-502 and 29-503; MedPath Compliance (reviewed 2026-06-20) calls it 'Nuanced'.
D.C. Code §§3-1201.02(7)(A), 29-502, 29-503 (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
State rules for cosmetics and sunscreenNo District of Columbia-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?
District of Columbia 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: Physicians dispensing from the office · Who may inject neuromodulators and fillers · Corporate practice of medicine / med spa ownership · State rules for cosmetics and sunscreen
Washington DC at a glance
Every topic we research, for Washington DC. 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 register with DC Health as a nonresident pharmacy before shipping prescription drugs or devices into the District of Columbia.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?
22-B DCMR §1903 requires nonresident pharmacies that dispense, distribute, ship, mail or deliver prescription drugs or medical devices into DC, directly or indirectly, to be registered by the Department of Health and to follow DC pharmacy and drug law (unless that would violate home-state law); no shipments are allowed until a Certificate of Registration issues. Applicants must show a home-state pharmacy license, a pharmacist-in-charge licensed in the home state (who signs an affidavit about DC law), DEA registration if shipping controlled substances, the most recent home-state or federal inspection report, whether they perform sterile compounding, and a DC resident agent; internet-based pharmacies must also hold NABP VIPPS (or equivalent) certification. Nonresident pharmacies must provide a toll-free pharmacist line (6 days/40 hours a week) on each label, keep DC dispensing records for 5 years, and produce records within 3 business days. DC Health's 2025 checklist lists a $900 nonresident pharmacy license fee and says a separate application is needed for each shipping location.
DC's credential is described as both a 'registration' (22-B DCMR §1903) and a 'Non-Resident Pharmacy license' (DC Health checklist). The rule asks whether the pharmacy does sterile compounding but sets no separate nonresident sterile-compounding permit. The in-District pharmacy license statute (D.C. Code §47-2885.03) applies to pharmacies 'within the District'; the nonresident requirement comes from the DCMR rule. Stale-source flag: the controlling text is dated 2024-03-05 (more than 2 years before 2026-09-23); it is the latest version found, but confirm with the board that it is still current.
22-B DCMR §1903 (as amended 69 DCR 2763, Apr. 1, 2022)
- 22-B DCMR §1903 — Registration of Nonresident Pharmacies — District of Columbia Office of Documents and Administrative Issuances (DC Register/DCMR), 2022-04-01
- Non-Resident Pharmacy Application Checklist (revised 3/5/2024) — DC Health, Pharmaceutical Control Division, 2024-03-05
- DC Health — Pharmacy Licensure — DC Health, 2026-09-23
Office-use compounding from 503A pharmaciesDC law is silent on office-use compounding; it allows compounding only 'as authorized by federal and District law,' and no DC rule on office use was found.Not confirmed
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.
D.C. Code §3-1201.02(11) defines the practice of pharmacy to include 'the compounding of drugs as authorized by federal and District law.' No DC statute or DCMR provision found (22-B DCMR ch. 19 Pharmacies; 17 DCMR ch. 65 Pharmacists) sets office-use quantities, labeling or other conditions, and none expressly prohibits office use. Because DC defers to federal law and FDA's position is that 503A compounding requires patient-specific prescriptions, DC law does not by itself confirm that a 503A pharmacy may supply office stock. DC Health's Pharmaceutical Control Division and the Board of Pharmacy regulate pharmacies.
Silent. §3-1201.02 was last amended by D.C. Law 26-105 (effective 2026-03-24); the fetched definition still ties compounding to federal and District law. The Board's policy-statement list (https://dchealth.dc.gov/node/158712, checked 2026-09-23) has no compounding or office-use statement. Check with DC Board of Pharmacy before relying on office-use supply.
D.C. Code §3-1201.02(11)
- D.C. Code §3-1201.02 — Definitions (practice of pharmacy) — Council of the District of Columbia (DC Code), 2026-03-24
- 22-B DCMR Chapter 19 — Pharmacies (section list) — District of Columbia Office of Documents and Administrative Issuances, 2026-09-23
- DC Board of Pharmacy — DC Health, 2026-09-23
503B outsourcing facilities shipping into the stateDC has no outsourcing-facility license, but an out-of-state 503B shipping drugs into DC must first obtain a DC Health drug manufacturer/distributor/wholesaler registration.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?
D.C. Code §48-702 bars manufacturing, distributing or wholesaling any drug in the District without a license or registration from the Mayor (DC Health), and §48-701 defines 'manufacture' to include compounding and 'wholesaler' to include manufacturers and pharmacies that distribute to anyone other than a consumer or patient. DC Health's checklist (revised 1/15/2025) states that an out-of-state or in-state manufacturer, distributor or wholesaler, 'or any other facility' that intends to ship prescription, OTC or controlled drugs to or within DC must first obtain a DC registration, with a $100 nonresident fee, proof of current FDA approval (manufacturers), home-state licensure, a list of products to be shipped, and the most recent state or federal inspection report (with corrective-action proof if deficiencies were cited). A separate application is required for each shipping location, and controlled substances require an additional DC controlled substance registration.
No DC provision names 'outsourcing facility'; the requirement for out-of-state facilities comes from DC Health's application checklist, while the statute speaks of activity 'in the District'. A 503B dispensing patient-specific prescriptions into DC would also need nonresident pharmacy registration (22-B DCMR §1903). 22-B DCMR ch. 4 text was not separately reviewed.
D.C. Code §§48-701, 48-702; 22-B DCMR ch. 4
- D.C. Code §48-702 — Prohibited acts (license required to manufacture, distribute or wholesale) — Council of the District of Columbia (DC Code), 2026-09-23
- D.C. Code §48-701 — Definitions — Council of the District of Columbia (DC Code), 2026-09-23
- Checklist for Submitting DC New License Application — Manufacturers, Distributors, and Wholesalers (revised 1/15/2025) — DC Health, Pharmaceutical Control Division, 2025-01-15
FDA compounding MOUDistrict of Columbia 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; District of Columbia 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 registrationThe District of Columbia requires every person who dispenses (which under the CSA model includes prescribing and administering) controlled substances in DC to hold a DC controlled substance registration, with a separate registration for each practice location.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.
D.C. Code Sec. 48-903.02(a) requires every person who manufactures, distributes or dispenses any controlled substance within DC to obtain annually a registration issued by the Mayor, and renewal applications must be filed at least 60 days before expiration or the registration abates. Subsection (e) requires a separate registration for each principal place of business or professional practice where controlled substances are dispensed. The statute vests issuance in the Mayor; the DC Health program page could not be opened in this session, so the agency office, fee and current cycle should be checked with DC Health. DEA registration requires state/district authority to handle controlled substances, so the DC registration is obtained before the DC DEA registration.
Fee and current renewal cycle could not be confirmed on a DC Health page in this session (the DC Health CSR page URLs tried returned 404); the statute text says 'annually'. Last statutory amendment shown is 1999 (D.C. Law 12-284), but the Code page is current.
D.C. Code Sec. 48-903.02
- D.C. Code Sec. 48-903.02. Registration - Required; renewal; exceptions; waiver; inspection — Council of the District of Columbia, 2026-09-23
- Registration Q&A (state authority prerequisite; separate registration per location) — DEA Diversion Control Division, 2024-12-01
PDMP check before prescribingDC requires a PDMP query only for courses of opioids or benzodiazepines longer than 7 consecutive days (then every 90 days), so testosterone is not covered.Required for some drugs only
Must a prescriber query the state Prescription Drug Monitoring Program before prescribing, and does the mandate cover Schedule III drugs such as testosterone? "Yes" means a mandate that reaches Schedule III; "conditional" means a mandate limited to certain drugs (e.g. opioids or benzodiazepines) or situations; "no" means no prescriber query mandate.
D.C. Code 48-853.03c requires a prescriber or delegate to query the DC PDMP before starting a new course of treatment that includes an opioid or benzodiazepine for more than 7 consecutive days, and every 90 days while it continues. Dispensers must query before dispensing an opioid or benzodiazepine for a course expected to last more than 7 days and before refills more than 90 days after the prior fill. Exceptions: hospice or palliative care; inpatient hospital admission or discharge; nursing home/residential care facilities using a sole-source pharmacy; system outages or disasters; and documented emergencies. Failure to comply is grounds for discipline by the relevant health occupations board and civil fines.
Source older than 2 years - possibly stale (section added eff. 3/16/2021; text confirmed on the official D.C. Law Library on 2026-09-23). The PDMP TTAC list cites 'D.C. Law 23-252 (D.C. Act 23-609)'; the Code's history note cites D.C. Law 23-251, § 101. Testosterone (C-III) is not caught.
D.C. Code § 48-853.03c (added by D.C. Law 23-251, § 101)
- D.C. Code Title 48, Chapter 8G - Prescription Drug Monitoring (§ 48-853.03c) — Council of the District of Columbia (D.C. Law Library), 2021-03-16
Physicians dispensing from the officeD.C. pharmacy law exempts a licensed practitioner who personally dispenses drugs to the practitioner's own patients.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.
D.C. Code 47-2885.01(b)(1) exempts from the pharmacy act a duly licensed medical practitioner who personally dispenses or administers drugs as the practitioner deems proper in treating the practitioner's patients. No separate dispensing permit was found in the statute. Controlled substances require a D.C. controlled substance registration and DEA registration.
D.C. Code 47-2885.01(b)(1)
- D.C. Code 47-2885.01. Purposes; scope — Council of the District of Columbia, 2026-09-23
Prescribing by telehealthD.C. requires a D.C. license and lets physicians establish the relationship by real-time telemedicine, following D.C. and federal controlled-substance rules.Allowed (standard rules)
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 health professional licensed in the District may provide telehealth to a person in D.C. consistent with the D.C. standard of care and scope of practice, and must follow all District and federal laws on prescriptions and controlled substances (D.C. Code 3-1201.05, as cited by CCHP). If there was no prior in-person interaction, a physician may use real-time telemedicine to establish the relationship and evaluate the patient (17 DCMR 4618). No D.C. telehealth-specific Schedule III limit was found. IMLC: member.
The Mayor may add in-person exam requirements for specific professions by rule; none found for physicians.
D.C. Code 3-1201.05 (as cited by CCHP); 17 DCMR 4618.3-4618.4
- District of Columbia - Professional Requirements — Center for Connected Health Policy (CCHP), 2026-08-13
- 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 District of Columbia rule or board statement on who may inject Botox or fillers was found; check with the DC Board of Nursing (DC Health).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 DC Board of Nursing (DC Health)'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.
- DC Board of Nursing (DC Health) — DC Board of Nursing (DC Health), 2026-09-23
IV hydration and vitamin therapyNo District of Columbia rule or board statement specific to elective IV hydration was found; check with the DC Board of Nursing (DC Health).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 DC Board of Nursing (DC Health)'s website was checked on 2026-09-23 for guidance on IV hydration clinics (prior exams, standing orders, mobile services) and none was found.
- DC Board of Nursing (DC Health) — DC Board of Nursing (DC Health), 2026-09-23
Corporate practice of medicine / med spa ownershipCompilations describe DC's corporate practice of medicine rule as moderate and based on statute and case law.CPOM with exceptions
Does the state enforce the corporate practice of medicine doctrine (non-physicians may not own medical practices or employ physicians), and how does that affect med spa ownership?
Permit Health's 2025 guide rates DC 'Moderate (Common Law)', citing D.C. Code §§3-1201.02(7)(A), 29-502 and 29-503; MedPath Compliance (reviewed 2026-06-20) calls it 'Nuanced'.
D.C. Code §§3-1201.02(7)(A), 29-502, 29-503 (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 District of Columbia rule on who may operate cosmetic lasers was confirmed; check with the DC Board of Medicine (DC Health).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 District of Columbia statute, rule or board policy on delegation of cosmetic laser/IPL procedures or a laser-operator credential was located on 2026-09-23.
- DC Board of Medicine (DC Health) — DC Board of Medicine (DC Health), 2026-09-23
Labs, regenerative medicine & cosmetics
State clinical laboratory licensing (beyond CLIA)DC Health acts as the federal CLIA agent; no separate District lab license was identified.CLIA only
Does the state license clinical laboratories itself, beyond federal CLIA certification, including out-of-state labs that test specimens from the state?
DC Health's laboratory page says it serves as the agent for federal CLIA certification, which is 'required for all clinical laboratory testing sites.' It asks labs with an out-of-state CLIA certificate that run temporary screenings or health fairs in DC to notify DC Health through a Health Awareness Screening form. The page describes no separate District license.
Confirm with DC Health (DCHealth.CLIA@dc.gov) that no DCMR licensing rule applies.
DC Health, Laboratories (CLIA) program page
- Laboratories (CLIA program) — DC Health, 2026-09-23
- CLIA State Agency Contacts (updated May 2026) — Centers for Medicare & Medicaid Services, 2026-05-01
Direct-to-consumer lab testingNot confirmed whether District of Columbia 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 District of Columbia's rule. District of Columbia's lab regulator (CLIA state agency) is DC Health, Health Care Facilities Division, Laboratory Programs (DCHealth.CLIA@dc.gov, 202-727-1740; https://dchealth.dc.gov/page/laboratories). 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 District of Columbia 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. District of Columbia 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 District of Columbia-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?
District of Columbia 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
Direct-to-consumer lab testing. 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.
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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