FDA and state rules, for what you actually buy.

Must a pharmacy located in another state hold a license/registration from this state to ship prescriptions (including patient-specific 503A compounded preparations) to patients or practitioners here?

Md. Code, Health Occ. §12-403(e) requires a nonresident pharmacy to hold a Board of Pharmacy permit and to have a Maryland-licensed pharmacist on staff designated as responsible for services to Maryland patients. To get the permit, it must submit its most recent home-state inspection report, name a Maryland agent for service of process, and, if it will dispense compounded sterile preparations to Maryland patients, submit a USP <797> inspection report done within 90 days before applying by a Board designee or Board-approved entity (§12-403(f)(1)(v)). It must also provide toll-free pharmacist access at least 6 days and 40 hours per week, print that number on labels, keep Maryland records readily retrievable, and follow USP <797> and the Board's sterile compounding rules (§12-403(g)). The Board's June 2025 application asks for an inspection report from the last 2 years, and its renewal page requires a USP <797> inspection dated within 90 days of renewal for sterile compounders.

The Board's site blocks some automated fetchers, so it was read in a browser. Washington's inspection directive accepts Maryland board inspections only for pharmacies that do not compound, which matters for Maryland-based compounders shipping to WA, not the reverse.

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.

COMAR 10.34.19.19 ('Office Use') says anyone preparing and distributing sterile compounded medications for office use into, out of or within Maryland must hold an FDA manufacturer's permit (or other FDA-designated permit) and, if applicable, a Maryland wholesale distributor permit. In practice that means an FDA-registered 503B facility or manufacturer, not a 503A pharmacy. Md. Code, Health Occ. §12-403(c)(22) allows only one human office-use exception without a patient-specific prescription: compounded antibiotics for emergency bacterial endophthalmitis or viral retinitis, and anti-VEGF agents for emergency neovascular glaucoma, wet macular degeneration or macular edema, supplied to an ophthalmologist who must report which patients received them. §12-403(c)(23) similarly allows non-patient-specific compounds for veterinarians. Advance ('batch') sterile compounding is limited to quantities supported by prior valid prescriptions (COMAR 10.34.19.08), which matches FDA's patient-specific view of 503A.

Non-sterile office-use compounding is not expressly addressed in what was reviewed. The statute's narrow office-use carve-outs and Maryland's definition of compounding (tied to a practitioner's prescription order or anticipated orders based on regular prescribing patterns, Health Occ. §12-101(f)) point to patient-specific dispensing. Confirm non-sterile office use with the Board (MDH.MDBOP@maryland.gov).

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?

Md. Code, Health Occ. §12-6C-03 requires a permit before any wholesale distribution in Maryland, and a manufacturer engaged in wholesale distribution must hold a wholesale distributor permit. The Board's current forms tell 503B facilities to use the 'Application for Manufacturers and Virtual Manufacturers Distributing Their Own Prescription Drugs or Devices,' not the general distributor application. That form (rev. 06/09/2025) asks for the FDA 503B registration date and number, sterile risk levels, a list of products distributed into Maryland, the most recent FDA inspection and a $1,750 fee. COMAR 10.34.19.19 separately requires anyone distributing sterile compounded office-use medications into Maryland to hold an FDA manufacturer or other FDA-designated permit and, if applicable, a Maryland wholesale distributor permit. The form also says a 503B that dispenses patient-specific prescriptions must additionally apply for a nonresident pharmacy permit.

Maryland has no separate 'outsourcing facility' license; 503Bs are permitted on the manufacturer/distributor track. The Wholesale Distributor application (rev. 08/04/2025) tells 503Bs not to use it. Out-of-state general wholesale distributors need accreditation or reciprocity, but the manufacturer form reviewed asks 503Bs for an FDA inspection instead.

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; Maryland is not among them. For a non-signing state, FD&C Act §503A(b)(3)(B)(ii) caps a 503A pharmacy's out-of-state distribution of compounded drugs at 5% of its total prescription orders. FDA now considers the October 2020 standard MOU suspended (it does not expect signatory states to carry out MOU activities and will not sign new ones) and is not enforcing the 5% limit until a final rule and an updated MOU are published; FDA's rulemaking (RIN 0910-AI71) listed a proposed rule for 11/2026 in the Fall 2025 Unified Agenda.

The FDA list of signed MOUs (current as of 2023-01-23) is older than 2 years, but FDA stopped entering new agreements under the 2020 MOU in October 2022, so no state can have signed since. The FDA "Compounding Information for States" page (current as of 2026-08-28) still describes the MOU as awaiting rulemaking. Pending: FDA proposed rule on 503A distribution (RIN 0910-AI71, NPRM projected 11/2026); H.R. 5316 (introduced 2025-09-11, referred to House Energy & Commerce) would remove the MOU provision from §503A.

Besides DEA registration, does the state require practitioners to hold a separate state controlled substance registration, license or permit to prescribe, administer or dispense controlled substances (e.g. testosterone, Schedule III)? "Conditional" means a state registration is needed only in some settings, such as keeping controlled-substance stock in the office.

Md. Code, Criminal Law Sec. 5-301 requires a person to be registered by the Department before manufacturing, distributing or dispensing a controlled dangerous substance in Maryland, and 'dispense' includes prescribing and administering (Sec. 5-101); an applicant must register separately each principal place of business or professional practice where it dispenses. Prescribers must attest to 2 hours of controlled-substance CE (Sec. 5-301(c)) and must be registered with the PDMP before obtaining a new or renewal registration (Sec. 5-304(b)). A registration expires on the date the Department sets and may not be renewed for more than 3 years (Sec. 5-302). Separately, a physician who personally prepares and dispenses drugs for a charge needs a written dispensing permit from the Board of Physicians and is subject to OCSA inspection (Health Occ. Sec. 12-102).

The OCSA website (health.maryland.gov/ocsa) returned 403 in this session, so fee and current term were not confirmed; statute caps the term at 3 years. The statute applies to all 'authorized providers' including NPs and PAs with prescriptive authority. Per-location: separate registration for each principal place of practice.

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.

Health-General 21-2A-04.2 requires a prescriber, since July 1, 2018, to request at least the prior 4 months of PDMP data before initiating a course of treatment that includes prescribing or dispensing an opioid or benzodiazepine, to repeat the request at least every 90 days if the course continues beyond 90 days, and to document the review. Exemptions: supplies of 3 days or less; cancer or cancer-related pain; hospital inpatients; hospice or terminally ill patients; residents of assisted living, long-term care, comprehensive care or developmental disabilities facilities; acute pain for up to 14 days after surgery, fracture, significant trauma or childbirth; low-abuse drugs listed by the Secretary; and delays harmful to the patient or system outages. Pharmacists must check only when they suspect misuse.

Frequency: start of course + every 90 days. The duty covers prescribers who dispense. Testosterone (C-III) is not caught.

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.

Health Occ. 12-102(c) lets a physician personally prepare and dispense only with a Board dispensing permit, only to the physician's own patients, and only without a substantial financial interest in a pharmacy. The physician must follow dispensing and labeling rules, record dispensing in the chart, keep prescription files (separate Schedule II files), allow the Office of Controlled Substances Administration to inspect, avoid steering patients to one pharmacy, and complete 10 CE credits on dispensing every 5 years. Starter doses (72 hours or less) and samples given free need no permit.

Maryland also requires a state CDS registration for controlled substances.

For a patient located in the state: must the prescriber hold this state's license (or a telehealth registration or special license), is an in-person exam required before prescribing (generally or for controlled substances), are there state limits on prescribing Schedule III drugs such as testosterone by telehealth, and is the state an Interstate Medical Licensure Compact member? "Yes" means a state license and the in-person standard of care apply (opioid-only or Schedule II-only limits are described but do not change the answer); "conditional" means extra state conditions such as a telehealth registration route, an in-person exam requirement, controlled-substance limits reaching Schedule III, or registration of telehealth businesses. Federal DEA rules apply on top.

Out-of-state physicians need a Maryland license apart from narrow adjoining-state exceptions (Health Occ. 14-301, 14-302); expedited licensure pathways exist. A practitioner may not prescribe a Schedule II opiate for pain through telehealth unless the patient is in a health care facility or the practitioner (or a group colleague) previously assessed the patient in person (Health Occ. 1-1003, amended 2025). Other controlled substances, including testosterone, follow general state and federal rules; asynchronous care requires a prior synchronous audio-video or in-person evaluation (COMAR 10.32.05.05). IMLC: member.

Health Occ. 1-1003 amended by HB 869 / SB 372 (2025 session) per CCHP.

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?

COMAR 10.32.09 (Board of Physicians) defines 'cosmetic medical procedure' to include subcutaneous, intradermal or intramuscular injections of medical products and devices used to inject substances into skin, fat, muscle or bone. A physician may delegate these to a PA or assign them to another health care provider licensed under the Health Occupations Article whose own board considers the procedure within scope, only if the person has the training in Regulation .07 and any training their own board requires. The physician must keep written office protocols at each site, personally perform each patient's initial assessment, prepare a written treatment plan (including device and settings), obtain informed consent to treatment by a non-physician, and provide on-site supervision whenever a non-physician performs the procedure (a Board-approved PA delegation agreement may allow 'immediately available' supervision after the physician's evaluation). Unlicensed staff are not eligible.

Regulation pages show no effective date (accessed 2026-09-23); the chapter references agreements approved before May 2009. The Maryland Board of Nursing site blocked automated access, so its own position on RN cosmetic injections was not checked.

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 Physicians' cosmetic procedure chapter (COMAR 10.32.09) covers cosmetic injections, not wellness IVs. The Maryland Board of Nursing's pages returned HTTP 403 to automated requests on 2026-09-23, so any declaratory ruling on IV hydration could not be reviewed.

Check with the Maryland Board of Nursing (mbon.maryland.gov).

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 Maryland 'Moderate (Common Law)', citing a Board of Physician Quality Assurance position statement and the Maryland Dentistry Act; MedPath Compliance (reviewed 2026-06-20) lists Maryland as 'Yes (common law)' based on board policy.

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?

Under COMAR 10.32.09, lasers, light/IPL and RF/microwave devices used cosmetically are 'cosmetic medical devices'. A physician may delegate or assign their use only to a PA or a licensed health care provider whose board deems it within scope and who has the training in Regulation .07. The physician must personally perform the initial assessment, write a treatment plan specifying device and settings, keep written protocols at each site, obtain informed consent and provide on-site supervision whenever a non-physician operates the device (except under a Board-approved PA agreement allowing immediately available supervision).

Training content in Regulation .07 was not reviewed.

Does the state license clinical laboratories itself, beyond federal CLIA certification, including out-of-state labs that test specimens from the state?

Health-General §17-205 requires a license from the Secretary to offer or perform medical laboratory tests, and expressly covers performing tests 'on specimens acquired from health care providers in this State at a medical laboratory located outside this State.' The Office of Health Care Quality runs the lab licensing program and is also Maryland's CLIA agency. The license is in addition to CLIA.

Out-of-state labs: yes. Contact: OHCQ.labs@maryland.gov.

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 Maryland's rule. Maryland's lab regulator (CLIA state agency) is Maryland Dept. of Health, Office of Health Care Quality (OHCQ.labs@maryland.gov, 410-402-8025). The question matters for take-home and consumer test kits, not for panels a clinician orders.

A commercial 2026 guide (Just Labs) lists Maryland among states that restrict independent test ordering; not confirmed. Maryland requires a state license for labs testing Maryland specimens. The ADLM figure dates from 2019 (older than 2 years).

Has the state enacted a law or rule specifically about stem cell, exosome or regenerative-medicine therapies (notice/disclosure duties, permission for certain non-FDA-approved uses, or Right to Try extensions covering them)?

Compilations of state stem-cell laws from 2024 to 2026 list about a dozen states with specific laws (California, Florida, Georgia, Mississippi, Nevada, North Carolina, Tennessee, Texas, Utah, Vermont, Washington and Wyoming), plus Montana's general experimental-treatment law and Kansas's state stem cell center. Maryland is not among them. Without a state-specific law, regenerative products are governed by federal FDA rules plus the state's general medical practice, advertising and consumer-protection laws, enforced by its medical board. Federal FDA rules still apply regardless of state law: stem cell, birth-tissue and exosome products are regulated by FDA, and a state law cannot make an unapproved biologic FDA-approved.

The finding of no law rests on multi-state compilations (a commercial one from Aug 2026 and a peer-reviewed one from Feb 2024, which is older than 2 years) and targeted searches, not a statute-by-statute review, and neither compilation is exhaustive. General Right to Try laws for terminal patients, where they exist, were not reviewed here.

Does the state have cosmetic or sunscreen requirements beyond federal MoCRA, such as ingredient bans (PFAS, formaldehyde, phthalates), ingredient reporting, sunscreen-ingredient bans, or bans on selling animal-tested cosmetics?

Health-General §21-259.2 (HB 643) bars knowingly manufacturing or selling cosmetics with intentionally added ingredients from its list: certain phthalates, formaldehyde, mercury, isobutyl- and isopropylparaben, m- and o-phenylenediamine, and specified PFAS compounds. Technically unavoidable trace amounts from impurities, manufacturing, storage or packaging are excepted. A 2026 law-firm review gives the effective date as Jan 1, 2025. Maryland is also listed among the states banning the sale of animal-tested cosmetics.

The effective date is from secondary sources; the statute page did not show it. The citation for Maryland's animal-testing law was not confirmed. The animal-testing list is Wikipedia's 'as of 2023' compilation (older than 2 years); effective dates were not confirmed. Federal MoCRA and FDA cosmetic and OTC sunscreen rules apply in every state.