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


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NAD+, vitamins & IV nutrients
FDA pathway: Compounded 503A/503B | Drug (NDA/ANDA) for approved vitamins and methylene blue
NAD, NADH, glutathione and methylcobalamin are 503A Category 1 (tolerated pending review); FDA warned in Aug 2026 against supplement-grade glutathione in injectables after patient reactions and Class I recalls.
On MedGrid as: NAD+ · Vitamin Injectables · Lipotropics (MIC/LIPO) · Glutathione
The federal rules
NAD, NADH, glutathione, methylcobalamin are 503A Category 1FDA does not intend to act against 503A compounding with these Category 1 substances if its conditions are met; they are not FDA-approved drugs.
Other Category 1 items relevant to wellness injectables include alpha lipoic acid, choline chloride, L-citrulline and pyridoxal 5-phosphate. 'Beta-nicotinamide adenine dinucleotide disodium salt trihydrate' is listed separately in Category 3.
Glutathione: use injectable-grade ingredientsFDA (Aug 27, 2026) reported at least 30 patients with reactions after IV glutathione and warned compounders not to use dietary-supplement-grade glutathione, which may contain endotoxins.
Reported symptoms included fever, chills, pain, dizziness and shock/sepsis-like signs. openFDA shows Class I recalls of compounded glutathione 200 mg/mL vials for endotoxin (Victory Medical Center Pharmacy, July 1, 2026; Optimal Balance Pharmacy, Aug 5, 2026).
- FDA reminds compounders not to use dietary supplement grade glutathione for injectables — FDA, 2026-08-27
- openFDA drug enforcement (recall) query: glutathione recalls 2025–2026 — FDA (openFDA), 2026-09-16
Methylene blueMethylene blue is FDA-approved only as an IV drug for methemoglobinemia (ProvayBlue, NDA 204630, 2016; several ANDAs 2023–2025); other uses and oral compounded forms are not FDA-approved.
Because it is the active ingredient of approved drugs, it can generally serve as a 503A bulk ingredient; FDA's Category 3 list includes an entry spelled 'Thylene blue', whose meaning is unclear.
- openFDA Drugs@FDA query: methylene blue applications — FDA (openFDA), 2026-09-22
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (Categories 1–3) — FDA, 2026-05-14
Lipotropic/MIC blends and vitamin cocktailsMulti-ingredient injections are compounded drugs; each ingredient must independently be an eligible bulk substance (monograph, approved-drug component, or bulks list/Category 1).
Ingredient-by-ingredient eligibility for methionine and inositol was not confirmed in this research. Choline chloride is Category 1. Clinics preparing IV bags on site may be 'compounding' under federal and state law (see iv_therapy).
Changing now
- FDA evaluation of Category 1 substances (NAD, glutathione, methylcobalamin) could move them onto or off the 503A bulks list. — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
- Ongoing glutathione recalls and FDA surveillance of IV wellness products. — FDA reminds compounders not to use dietary supplement grade glutathione for injectables
What Virginia adds
Out-of-state pharmacies shipping into the stateAny out-of-state pharmacy shipping prescription drugs into Virginia must register with the Virginia Board of Pharmacy as a nonresident pharmacy and name a Virginia-licensed pharmacist in charge.License required
Must a pharmacy located in another state hold a license/registration from this state to ship prescriptions (including patient-specific 503A compounded preparations) to patients or practitioners here?
Under Va. Code §54.1-3434.1, any pharmacy outside Virginia that ships, mails or delivers Schedule II–VI drugs or devices into Virginia by prescription must register as a nonresident pharmacy. Schedule VI covers all other prescription drugs. It must designate a pharmacist in charge licensed in Virginia, keep an unrestricted home-state license, and file a current home-state inspection report showing USP-NF compliance for sterile and non-sterile compounding. That report must be no more than 6 months old for a new registration and 2 years old for a renewal. Board Guidance Document 110-38 accepts NABP or Gates Healthcare Associates inspections instead. A pharmacy doing sterile compounding must file an 'operational' inspection report, not just an 'opening' one. Other duties: NABP VIPPS (or Board-approved equivalent) certification if more than 50% of prescriptions come from internet solicitation, a toll-free pharmacist line at least 6 days and 40 hours a week, PMP reporting, and a continuous quality improvement program. A nonresident pharmacy that does sterile compounding must also notify the Board that it intends to ship sterile compounded products into Virginia (§54.1-3410.2(K)).
The Code page showed the statute as current on 9/23/2026 (last amended 2016, c. 221). The LIS 2026 updates index did not list §54.1-3434.1 or §54.1-3410.2. The Board's guidance page lists GD 110-38 as effective June 19, 2025. The Virginia-licensed pharmacist-in-charge requirement does not apply to a registered nonresident pharmacy that acts only as a pharmacy benefits administrator. Under §54.1-3434.1(E), a nonresident pharmacy may deliver dispensed controlled substances only to the patient or the patient's agent, or to a Virginia pharmacy.
Va. Code §54.1-3434.1; §54.1-3410.2(K); Va. Bd. of Pharmacy Guidance Document 110-38
- Va. Code §54.1-3434.1 — Nonresident pharmacies to register with Board — Virginia General Assembly (Legislative Information System), 2026-09-23
- Guidance Document 110-38 — Requirement for Non-resident Pharmacies and Outsourcing Facilities to Submit Current Inspection Report (revised March 25, 2025) — Virginia Board of Pharmacy, 2025-03-25
- Va. Code §54.1-3410.2 — Compounding — Virginia General Assembly (Legislative Information System), 2026-09-23
Office-use compounding from 503A pharmaciesVirginia lets pharmacists supply a 'reasonable amount' of compounded drugs for in-office administration only for a critical need to treat an emergency, or as allowed by federal law, with a 'For Administering in Prescriber Practice Location Only' label.Allowed with limits
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.
Va. Code §54.1-3410.2(A)–(C) limits pharmacist compounding to dispensing on valid prescriptions for specific patients, or in anticipation of such prescriptions based on regular patterns. It bars distributing compounded products for resale or further distribution. The one office-use exception: a pharmacist 'may provide a reasonable amount of compounded products to practitioners of medicine, osteopathy, podiatry, or dentistry to administer to their patients, either personally or under their direct and immediate supervision, if there is a critical need to treat an emergency condition, or as allowed by federal law or regulations.' Each unit must be labeled 'For Administering in Prescriber Practice Location Only', with the name and strength, control number, beyond-use date, pharmacy name and address, and quantity. FDA treats 503A compounding as patient-specific, so routine (non-emergency) office stock under the 'federal law' route generally means a 503B outsourcing facility. The statute does not separately address nonresident pharmacies shipping office stock; registered nonresident pharmacies must follow Virginia's drug laws.
Section last amended by 2025 Acts cc. 48 and 71, per the Code's history line. The companion-animal and veterinary office-use language appears to be the recent change; the chapter text was not retrieved. The LIS 2026 updates index shows no 2026 change to §54.1-3410.2. §54.1-3410.2(H)(2) also bars regularly compounding, or compounding inordinate amounts of, essentially copies of commercially available drugs, with limited exceptions (e.g., shortage, a prescriber-ordered change for an individual patient). No 2025–2026 Virginia Board guidance specific to GLP-1 or peptide compounding was found on the Board's news or guidance pages.
Va. Code §54.1-3410.2(A)–(C)
- Va. Code §54.1-3410.2 — Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements — Virginia General Assembly (Legislative Information System), 2026-09-23
503B outsourcing facilities shipping into the stateAn out-of-state 503B outsourcing facility must register with the Virginia Board of Pharmacy as a nonresident outsourcing facility before shipping any prescription drugs into Virginia.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?
Va. Code §54.1-3434.5 requires any outsourcing facility outside Virginia that ships, mails or delivers Schedule II–VI drugs or devices into Virginia to register as a nonresident outsourcing facility. The application must be signed by a Virginia-licensed pharmacist who is in full and actual charge of the facility and responsible for its compliance. The facility must be registered with FDA under 21 U.S.C. §353b and must file an FDA inspection report no more than 1 year old for a new registration and 2 years old for a renewal. If FDA has not inspected within that window, Guidance Document 110-38 accepts cGMP inspections by the California or Florida Board of Pharmacy or Bestech GMP. Registration renews annually. To fill patient-specific prescriptions, a nonresident outsourcing facility must also register as a nonresident pharmacy (§54.1-3434.5(D)).
The briefing lead cited §54.1-3434.05; that section is the in-state outsourcing facility permit. The nonresident registration is §54.1-3434.5, enacted 2015, c. 300. Outsourcing facilities must compound under federal law and cGMP and are exempt from the pharmacy compounding section §54.1-3410.2. The LIS 2026 updates index shows no 2026 change to either section.
Va. Code §54.1-3434.5; §54.1-3434.05 (in-state permit); Va. Bd. of Pharmacy Guidance Document 110-38
- Va. Code §54.1-3434.5 — Nonresident outsourcing facilities to register with the Board — Virginia General Assembly (Legislative Information System), 2026-09-23
- Va. Code §54.1-3434.05 — Permit to act as an outsourcing facility — Virginia General Assembly (Legislative Information System), 2026-09-23
- Guidance Document 110-38 — Requirement for Non-resident Pharmacies and Outsourcing Facilities to Submit Current Inspection Report (revised March 25, 2025) — Virginia Board of Pharmacy, 2025-03-25
Physicians dispensing from the officeVirginia practitioners need a Board of Pharmacy license to dispense, and the dispensing facility needs a permit.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.
Va. Code 54.1-3304.1 makes it unlawful for a practitioner of the healing arts to dispense controlled substances unless licensed by the Board of Pharmacy to sell controlled substances; facilities where practitioners dispense must hold a Board permit (single-practitioner facilities are exempt from the permit fee). Because Virginia's Drug Control Act treats prescription drugs as Schedule VI controlled substances, this covers ordinary prescription drugs too. A vendor summary notes that each dispensing physician needs an individual license and the facility may be inspected.
Virginia's Drug Control Act includes Schedule VI prescription drugs, so the license covers ordinary prescription drugs. 54.1-3304.1 was amended by 2026 Acts cc. 929 and 941 (per the Code history line); fees and renewal for the practitioner license were not reviewed.
Va. Code 54.1-3304.1
- Va. Code 54.1-3304.1 - Authority to license and regulate practitioners — Virginia Law (Virginia General Assembly), 2026-09-23
Who may inject neuromodulators and fillersVirginia law lets RNs and properly trained personnel give injections under the orders of a physician, APRN or PA; no Virginia rule specific to Botox or fillers was found.RNs may inject under delegation
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?
Va. Code §54.1-2901(A)(4) exempts from the unlicensed-practice prohibition any RN, APRN or other properly trained technical personnel rendering care within their usual professional activities, including intravenous infusions and injections, when performed under the orders of a physician, APRN or PA. Subsection (A)(6) separately lets practitioners delegate nondiscretionary tasks to supervised personnel. Board of Medicine rule 18VAC85-20-29 bars delegating patient care to subordinates who are not properly trained and supervised. No Board of Medicine or Nursing rule specific to neuromodulators or fillers was located.
Board of Medicine and Nursing guidance-document lists load dynamically and were not reviewed; they may contain cosmetic-injection guidance.
Va. Code §54.1-2901(A)(4), (A)(6); 18VAC85-20-29
- Code of Virginia §54.1-2901 – Exceptions and exemptions generally — Virginia General Assembly (LIS), 2026-09-23
- 18VAC85-20-29 – Practitioner responsibility — Virginia General Assembly (LIS) – Board of Medicine regulation, 2025-02-27
IV hydration and vitamin therapyVirginia law expressly lets RNs and properly trained personnel give IV infusions and injections under the orders of a physician, APRN or PA; no IV-hydration-specific rule was found.Standard medical/nursing rules
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?
Va. Code §54.1-2901(A)(4) permits RNs, APRNs and properly trained technical personnel to give intravenous infusions and injections within their usual professional activities when performed under the orders of a physician, APRN or PA. No Virginia board statement on elective IV hydration, prior exams, standing orders or mobile IV services was located.
Check with the Virginia Board of Nursing for any IV-hydration guidance document.
Va. Code §54.1-2901(A)(4)
- Code of Virginia §54.1-2901 – Exceptions and exemptions generally — Virginia General Assembly (LIS), 2026-09-23
Corporate practice of medicine / med spa ownershipCompilations list Virginia as a state without a meaningful corporate practice of medicine bar; a 2026 bill proposed studying the issue.No meaningful CPOM
Does the state enforce the corporate practice of medicine doctrine (non-physicians may not own medical practices or employ physicians), and how does that affect med spa ownership?
Permit Health's 2025 guide lists Virginia among non-CPOM states, citing Va. Code §§54.1-2902 and 54.1-111, Attorney General opinions (1955, 1992) and Board of Medicine Guidance Document 85-21. MedPath Compliance (reviewed 2026-06-20) also lists Virginia as 'No' and reports HB 1458 (2026), a study bill on corporate practice.
Va. Code §§54.1-2902, 54.1-111; Board of Medicine Guidance Doc. 85-21 (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
Compare every state: Out-of-state pharmacies shipping into the state · Office-use compounding from 503A pharmacies · 503B outsourcing facilities shipping into the state · Physicians dispensing from the office · Who may inject neuromodulators and fillers · IV hydration and vitamin therapy · Corporate practice of medicine / med spa ownership
Virginia at a glance
Every topic we research, for Virginia. Open any line for the rule, its citation and the source.
Pharmacy & compounding
Out-of-state pharmacies shipping into the stateAny out-of-state pharmacy shipping prescription drugs into Virginia must register with the Virginia Board of Pharmacy as a nonresident pharmacy and name a Virginia-licensed pharmacist in charge.License required
Must a pharmacy located in another state hold a license/registration from this state to ship prescriptions (including patient-specific 503A compounded preparations) to patients or practitioners here?
Under Va. Code §54.1-3434.1, any pharmacy outside Virginia that ships, mails or delivers Schedule II–VI drugs or devices into Virginia by prescription must register as a nonresident pharmacy. Schedule VI covers all other prescription drugs. It must designate a pharmacist in charge licensed in Virginia, keep an unrestricted home-state license, and file a current home-state inspection report showing USP-NF compliance for sterile and non-sterile compounding. That report must be no more than 6 months old for a new registration and 2 years old for a renewal. Board Guidance Document 110-38 accepts NABP or Gates Healthcare Associates inspections instead. A pharmacy doing sterile compounding must file an 'operational' inspection report, not just an 'opening' one. Other duties: NABP VIPPS (or Board-approved equivalent) certification if more than 50% of prescriptions come from internet solicitation, a toll-free pharmacist line at least 6 days and 40 hours a week, PMP reporting, and a continuous quality improvement program. A nonresident pharmacy that does sterile compounding must also notify the Board that it intends to ship sterile compounded products into Virginia (§54.1-3410.2(K)).
The Code page showed the statute as current on 9/23/2026 (last amended 2016, c. 221). The LIS 2026 updates index did not list §54.1-3434.1 or §54.1-3410.2. The Board's guidance page lists GD 110-38 as effective June 19, 2025. The Virginia-licensed pharmacist-in-charge requirement does not apply to a registered nonresident pharmacy that acts only as a pharmacy benefits administrator. Under §54.1-3434.1(E), a nonresident pharmacy may deliver dispensed controlled substances only to the patient or the patient's agent, or to a Virginia pharmacy.
Va. Code §54.1-3434.1; §54.1-3410.2(K); Va. Bd. of Pharmacy Guidance Document 110-38
- Va. Code §54.1-3434.1 — Nonresident pharmacies to register with Board — Virginia General Assembly (Legislative Information System), 2026-09-23
- Guidance Document 110-38 — Requirement for Non-resident Pharmacies and Outsourcing Facilities to Submit Current Inspection Report (revised March 25, 2025) — Virginia Board of Pharmacy, 2025-03-25
- Va. Code §54.1-3410.2 — Compounding — Virginia General Assembly (Legislative Information System), 2026-09-23
Office-use compounding from 503A pharmaciesVirginia lets pharmacists supply a 'reasonable amount' of compounded drugs for in-office administration only for a critical need to treat an emergency, or as allowed by federal law, with a 'For Administering in Prescriber Practice Location Only' label.Allowed with limits
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.
Va. Code §54.1-3410.2(A)–(C) limits pharmacist compounding to dispensing on valid prescriptions for specific patients, or in anticipation of such prescriptions based on regular patterns. It bars distributing compounded products for resale or further distribution. The one office-use exception: a pharmacist 'may provide a reasonable amount of compounded products to practitioners of medicine, osteopathy, podiatry, or dentistry to administer to their patients, either personally or under their direct and immediate supervision, if there is a critical need to treat an emergency condition, or as allowed by federal law or regulations.' Each unit must be labeled 'For Administering in Prescriber Practice Location Only', with the name and strength, control number, beyond-use date, pharmacy name and address, and quantity. FDA treats 503A compounding as patient-specific, so routine (non-emergency) office stock under the 'federal law' route generally means a 503B outsourcing facility. The statute does not separately address nonresident pharmacies shipping office stock; registered nonresident pharmacies must follow Virginia's drug laws.
Section last amended by 2025 Acts cc. 48 and 71, per the Code's history line. The companion-animal and veterinary office-use language appears to be the recent change; the chapter text was not retrieved. The LIS 2026 updates index shows no 2026 change to §54.1-3410.2. §54.1-3410.2(H)(2) also bars regularly compounding, or compounding inordinate amounts of, essentially copies of commercially available drugs, with limited exceptions (e.g., shortage, a prescriber-ordered change for an individual patient). No 2025–2026 Virginia Board guidance specific to GLP-1 or peptide compounding was found on the Board's news or guidance pages.
Va. Code §54.1-3410.2(A)–(C)
- Va. Code §54.1-3410.2 — Compounding; pharmacists' authority to compound under certain conditions; labeling and record maintenance requirements — Virginia General Assembly (Legislative Information System), 2026-09-23
503B outsourcing facilities shipping into the stateAn out-of-state 503B outsourcing facility must register with the Virginia Board of Pharmacy as a nonresident outsourcing facility before shipping any prescription drugs into Virginia.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?
Va. Code §54.1-3434.5 requires any outsourcing facility outside Virginia that ships, mails or delivers Schedule II–VI drugs or devices into Virginia to register as a nonresident outsourcing facility. The application must be signed by a Virginia-licensed pharmacist who is in full and actual charge of the facility and responsible for its compliance. The facility must be registered with FDA under 21 U.S.C. §353b and must file an FDA inspection report no more than 1 year old for a new registration and 2 years old for a renewal. If FDA has not inspected within that window, Guidance Document 110-38 accepts cGMP inspections by the California or Florida Board of Pharmacy or Bestech GMP. Registration renews annually. To fill patient-specific prescriptions, a nonresident outsourcing facility must also register as a nonresident pharmacy (§54.1-3434.5(D)).
The briefing lead cited §54.1-3434.05; that section is the in-state outsourcing facility permit. The nonresident registration is §54.1-3434.5, enacted 2015, c. 300. Outsourcing facilities must compound under federal law and cGMP and are exempt from the pharmacy compounding section §54.1-3410.2. The LIS 2026 updates index shows no 2026 change to either section.
Va. Code §54.1-3434.5; §54.1-3434.05 (in-state permit); Va. Bd. of Pharmacy Guidance Document 110-38
- Va. Code §54.1-3434.5 — Nonresident outsourcing facilities to register with the Board — Virginia General Assembly (Legislative Information System), 2026-09-23
- Va. Code §54.1-3434.05 — Permit to act as an outsourcing facility — Virginia General Assembly (Legislative Information System), 2026-09-23
- Guidance Document 110-38 — Requirement for Non-resident Pharmacies and Outsourcing Facilities to Submit Current Inspection Report (revised March 25, 2025) — Virginia Board of Pharmacy, 2025-03-25
FDA compounding MOUVirginia 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; Virginia 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 registrationVirginia exempts individual physicians, PAs and nurse practitioners from its controlled substances registration, but requires a Board of Pharmacy license to dispense (sell) controlled substances from a practice and may require a controlled substances registration for sites that keep a common stock of drugs.Required in some settings
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.
Va. Code 54.1-3422(A) requires an annual Board of Pharmacy controlled substances registration (CSR) for anyone who dispenses Schedule I-V substances, but exempts licensed practitioners of medicine, osteopathy, nursing and PAs; a separate registration is required at each principal place of business (54.1-3422(D)). Under 54.1-3304.1, it is unlawful for a practitioner to dispense controlled substances unless licensed by the Board of Pharmacy to sell controlled substances, and the facility must also hold a Board permit (fee-exempt when only one practitioner at the facility holds the license); Virginia's Drug Control Act also includes Schedule VI prescription drugs. Under 54.1-3423(D) and 18VAC110-20-690, outpatient clinics and similar entities may obtain a CSR to keep a stock of Schedule II-VI drugs (after inspection), and the Board may require one where drugs are used as common stock by multiple practitioners and there are red flags such as large purchases, diversion or recordkeeping failures.
Prescribing and in-office administering by an individual MD/DO/NP/PA need no Virginia CSR; dispensing take-home CS needs the practitioner 'license to sell' plus facility permit. 54.1-3304.1 was amended by 2026 Acts cc. 929 and 941 (per the Code history line). Fees and renewal for the practitioner dispensing license were not reviewed.
Va. Code 54.1-3422; 54.1-3423; 54.1-3304.1; 18VAC110-20-690
- Va. Code 54.1-3422 - Controlled substances registration certificate required in addition to other requirements; exemptions — Virginia General Assembly (LIS), 2026-09-23
- Va. Code 54.1-3423 - Board to issue registration unless inconsistent with public interest — Virginia General Assembly (LIS), 2026-09-23
- Va. Code 54.1-3304.1 - Authority to license and regulate practitioners; permits — Virginia General Assembly (LIS), 2026-09-23
- 18VAC110-20-690 - Persons or entities authorized or required to obtain a controlled substances registration — Virginia General Assembly (LIS) / Board of Pharmacy, 2026-09-23
PDMP check before prescribingVirginia requires a PMP request only when starting a new course of opioids expected to last more than 7 consecutive days (plus before opioid-addiction treatment agreements), 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.
Va. Code Sec. 54.1-2522.1(B) (version in effect until July 1, 2027) requires a registered prescriber or delegate, when initiating a new course of treatment that includes opioids anticipated to last more than seven consecutive days, to request PMP information on other covered substances and prior opioid overdoses; prescribers of opioid-addiction therapy must also check before or with the treatment agreement. Exemptions in subsection C: hospice or palliative care, inpatient admission or discharge, nursing homes or assisted living facilities using a sole-source pharmacy, sickle cell pain, and PMP outages or emergencies/disasters. All prescribers of covered substances must be registered with the PMP, which the Department of Health Professions runs. Board of Medicine opioid rules (18VAC85-21) add PMP checks for opioid prescribing.
The official code shows two versions: the current one (effective until July 1, 2027) and a version effective July 1, 2027 that requires a PMP request when initiating treatment with a benzodiazepine or an opiate anticipated to last more than 90 consecutive days, with exemptions for low-abuse-potential drugs listed by the Secretary and for dialysis, cancer or sickle cell pain. Neither version covers testosterone. History includes 2023 cc. 740, 773; 2024 c. 635; 2025 cc. 168, 487.
Va. Code Sec. 54.1-2522.1
- Code of Virginia Sec. 54.1-2522.1 - Requirements of practitioners — Virginia General Assembly (Legislative Information System), 2026-09-23
Physicians dispensing from the officeVirginia practitioners need a Board of Pharmacy license to dispense, and the dispensing facility needs a permit.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.
Va. Code 54.1-3304.1 makes it unlawful for a practitioner of the healing arts to dispense controlled substances unless licensed by the Board of Pharmacy to sell controlled substances; facilities where practitioners dispense must hold a Board permit (single-practitioner facilities are exempt from the permit fee). Because Virginia's Drug Control Act treats prescription drugs as Schedule VI controlled substances, this covers ordinary prescription drugs too. A vendor summary notes that each dispensing physician needs an individual license and the facility may be inspected.
Virginia's Drug Control Act includes Schedule VI prescription drugs, so the license covers ordinary prescription drugs. 54.1-3304.1 was amended by 2026 Acts cc. 929 and 941 (per the Code history line); fees and renewal for the practitioner license were not reviewed.
Va. Code 54.1-3304.1
- Va. Code 54.1-3304.1 - Authority to license and regulate practitioners — Virginia Law (Virginia General Assembly), 2026-09-23
Prescribing by telehealthVirginia requires a Virginia license (it is not an IMLC member) and adds telehealth-specific conditions for Schedule II-V prescribing, including a Virginia practice location or the ability to refer the patient for an in-person exam.Allowed with extra conditions
For a patient located in the state: must the prescriber hold this state's license (or a telehealth registration or special license), is an in-person exam required before prescribing (generally or for controlled substances), are there state limits on prescribing Schedule III drugs such as testosterone by telehealth, and is the state an Interstate Medical Licensure Compact member? "Yes" means a state license and the in-person standard of care apply (opioid-only or Schedule II-only limits are described but do not change the answer); "conditional" means extra state conditions such as a telehealth registration route, an in-person exam requirement, controlled-substance limits reaching Schedule III, or registration of telehealth businesses. Federal DEA rules apply on top.
(1) Prescribing to patients in Virginia requires a Virginia license; narrow exemptions cover consultation with Virginia practitioners and continuity-of-care telemedicine by out-of-state physicians for current patients they examined in person within the previous 12 months (Va. Code 54.1-2901(A)(15), (A)(35)). (2) There is no blanket in-person exam requirement: a bona fide relationship for prescribing Schedule II-VI drugs may be established by real-time audio-video or store-and-forward exam if listed conditions are met, including Virginia licensure, a standard of care that does not require an in-person exam and, if the patient is in a health plan, the prescriber being credentialed by that plan. (3) For Schedule II-V drugs (including C-III testosterone) prescribed via telemedicine, the prescriber must comply with federal telemedicine rules and must either maintain a practice at a physical location in Virginia or be able to refer the patient to a Virginia practitioner for an in-person exam when the standard of care requires one. (4) IMLC: not a member.
Classified conditional because Va. Code 54.1-3303 attaches telehealth-specific conditions (Virginia practice location or in-person referral capability; health-plan credentialing when establishing the relationship by telemedicine) to Schedule II-V prescribing, which reaches Schedule III. Board Guidance Doc. 85-12 (Aug. 19, 2021) was read via CCHP, not directly; it says audio-only follow-up for existing patients does not itself require Virginia licensure. Behavioral-health continuity exemption: 54.1-2901(A)(33).
Va. Code 54.1-3303(B); Va. Code 54.1-2901(A)(15), (A)(35); VA Board of Medicine Guidance Doc. 85-12
- Code of Virginia 54.1-3303 - Prescriptions to be issued and drugs to be dispensed for medical or therapeutic purposes only — Virginia General Assembly, 2026-09-23
- Code of Virginia 54.1-2901 - Exceptions and exemptions generally — Virginia General Assembly, 2026-09-23
- CCHP - Virginia telehealth policy (Professional Requirements), quoting VA Board of Medicine Telemedicine Guidance Doc. 85-12 — Center for Connected Health Policy, 2026-04-27
- 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 fillersVirginia law lets RNs and properly trained personnel give injections under the orders of a physician, APRN or PA; no Virginia rule specific to Botox or fillers was found.RNs may inject under delegation
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?
Va. Code §54.1-2901(A)(4) exempts from the unlicensed-practice prohibition any RN, APRN or other properly trained technical personnel rendering care within their usual professional activities, including intravenous infusions and injections, when performed under the orders of a physician, APRN or PA. Subsection (A)(6) separately lets practitioners delegate nondiscretionary tasks to supervised personnel. Board of Medicine rule 18VAC85-20-29 bars delegating patient care to subordinates who are not properly trained and supervised. No Board of Medicine or Nursing rule specific to neuromodulators or fillers was located.
Board of Medicine and Nursing guidance-document lists load dynamically and were not reviewed; they may contain cosmetic-injection guidance.
Va. Code §54.1-2901(A)(4), (A)(6); 18VAC85-20-29
- Code of Virginia §54.1-2901 – Exceptions and exemptions generally — Virginia General Assembly (LIS), 2026-09-23
- 18VAC85-20-29 – Practitioner responsibility — Virginia General Assembly (LIS) – Board of Medicine regulation, 2025-02-27
IV hydration and vitamin therapyVirginia law expressly lets RNs and properly trained personnel give IV infusions and injections under the orders of a physician, APRN or PA; no IV-hydration-specific rule was found.Standard medical/nursing rules
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?
Va. Code §54.1-2901(A)(4) permits RNs, APRNs and properly trained technical personnel to give intravenous infusions and injections within their usual professional activities when performed under the orders of a physician, APRN or PA. No Virginia board statement on elective IV hydration, prior exams, standing orders or mobile IV services was located.
Check with the Virginia Board of Nursing for any IV-hydration guidance document.
Va. Code §54.1-2901(A)(4)
- Code of Virginia §54.1-2901 – Exceptions and exemptions generally — Virginia General Assembly (LIS), 2026-09-23
Corporate practice of medicine / med spa ownershipCompilations list Virginia as a state without a meaningful corporate practice of medicine bar; a 2026 bill proposed studying the issue.No meaningful CPOM
Does the state enforce the corporate practice of medicine doctrine (non-physicians may not own medical practices or employ physicians), and how does that affect med spa ownership?
Permit Health's 2025 guide lists Virginia among non-CPOM states, citing Va. Code §§54.1-2902 and 54.1-111, Attorney General opinions (1955, 1992) and Board of Medicine Guidance Document 85-21. MedPath Compliance (reviewed 2026-06-20) also lists Virginia as 'No' and reports HB 1458 (2026), a study bill on corporate practice.
Va. Code §§54.1-2902, 54.1-111; Board of Medicine Guidance Doc. 85-21 (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 lasersVirginia lets physicians delegate laser hair removal to properly trained people (training incl. 10 proctored cases, unless the delegate is a PA or NP) while the physician is readily available, not necessarily on site.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 Medicine rule 18VAC85-20-91 (effective 2019-08-07) requires a physician who performs or supervises laser hair removal to be trained in skin physiology, skin typing and patient selection, laser safety, device operation, complications, and at least 10 proctored cases. A physician may delegate laser hair removal to a properly trained person under direction and supervision, meaning the physician is readily available during treatment but need not be physically present; delegates other than PAs and NPs must complete the same training, all must keep up ongoing training, and the physician must see any patient with complications before treatment continues. Other cosmetic lasers fall under general delegation rules.
Rule adopted 2019 (over two years old) but shown as current on LIS on 2026-09-23.
18VAC85-20-91 (eff. 2019-08-07)
- 18VAC85-20-91 – Practice and supervision of laser hair removal — Virginia General Assembly (LIS) – Board of Medicine regulation, 2019-08-07
Labs, regenerative medicine & cosmetics
State clinical laboratory licensing (beyond CLIA)Not confirmed. No Virginia 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). Virginia was not among them, but this research did not confirm its statutes. Virginia's CLIA state agency is Virginia Dept. of Health, Office of Licensure and Certification (CLIAlab@vdh.virginia.gov, 804-367-2107); 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 Virginia 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 Virginia's rule. Virginia's lab regulator (CLIA state agency) is Virginia Dept. of Health, Office of Licensure and Certification (CLIAlab@vdh.virginia.gov, 804-367-2107). 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 Virginia 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. Virginia 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 sunscreenVirginia is listed among the states that ban the sale of cosmetics tested on animals; no PFAS-in-cosmetics or sunscreen law was found.State cosmetic/sunscreen rules
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?
A 2023 compilation lists Virginia among the ten states with cosmetic animal-testing sales bans. Virginia does not appear on 2026 lists of states with PFAS-in-cosmetics laws.
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.
Virginia cosmetic animal-testing law (citation not confirmed)
- Testing cosmetics on animals (US state bans 'as of 2023') — Wikipedia, 2026-09-23
- PFAS in Cosmetics: US State Bans and Compliance Deadlines - 2026 Update — Adherent (formerly Compliance & Risks), 2026-03-13
Compare every state
Physicians dispensing from the office. 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.
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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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.
