July 25, 2023

Note: The following listings are prohibited for any seller not authorized to sell Rx medical devices through the Professional Health Care Program.

  • Products that require a prescription or a medical professional’s supervision or direction for their use
  • Products that are labeled for professional use only or not for retail sale
  • Products that have been classified by the FDA as medical devices that require FDA clearance or approval that have not been cleared or approved by the FDA for over-the-counter use, such as:
    • Acupuncture/intradermal needles
    • Anesthetic vaporizers
    • Asthma inhalers
    • Bacteriostatic water
    • Cancer testsExamples of cancer tests include:
      • PSA Prostate specific antigen
      • High-sensitivity CRP home test kit
      • Cervical cancer test
    • Cardiac monitor
    • Cavity varnishExamples of Cavity varnish include:
      • Ascent F-Coat
      • Copal varnish with fluoride
      • Fluoridex
      • GC Fuji varnish
      • GLUMA Desensitizer PowerGel
      • MI Varnish
      • NUPRO
      • Pulpdent fluoride varnish
      • Vanish varnish
    • Chin-up strip
    • Circumcision devices
    • Contact lenses
    • Continuous, Variable and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and certain accessoriesThe following are examples of Continuous, Variable and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and their accessories:
      • BiPAP Plus
      • CPAP Masks
      • DeVilbiss IntelliPAP
      • iDPAP Celestia CPAP Machine
      • Polaris EX CPAP
      • Respironics REMstar
      • RPM Bilevel CPAP System
    • Cranial electrotherapy stimulators
    • Defibrillators (unless approved or cleared for over-the-counter use)Examples of defibrillators include:
      • HeartStart OnSite AED
      • HeartStart FRx AED
      • HeartStart MRx
      • Lifeline AED
      • Medtronic LIFEPAK
      • MRL LifeQuest AED
      • Welch Allyn AED 20
      • ZOLL AED Pro
    • Dental devicesExamples of prescription and professional-use only dental devices include:
      • Dental Burs
      • Dental X-Ray units
      • Denture relining, repairing, or rebasing resin, such as dental handpiece or dental drill
    • Electronic stethoscopes
    • Electrosurgical cutting and coagulation devices
    • Fetal Dopplers
    • Home HIV test kits, with the exception of the Home Access HIV-1 Test System, which has been approved for over-the-counter use by the FDA
    • Hypodermic needles and insulin injectors, such as Monoject Safety Syringes
    • Infant heel warmers
    • Implantable devices, such as pacemakers
    • Infusion pumps and their accessories (with exception of batteries, which are permitted)
    • Infusion set
    • Insulin pumps
    • Laser combs
    • Mandibular advancement devicesExamples of mandibular advancement devices include:
      • Airflow Pressure Transducer
      • Dymedix Reusable Airflow/Snore Sensor
      • Nose Breathe Mouthpiece for Heavy Snorer
      • Quiet Night Sleep Appliance
      • Removable Acrylic Herbst
      • Snore Guard
      • Snore Guard Advance
      • Snore Hook Discluder
      • Snore Sat Recorder
      • Snore-Aid Max
    • Mesotherapy products
    • Nebulizers and their accessories, such as holding chambers
    • Oral cavity abrasive polishing agents
    • Oxygen concentrators, compressors, conservers, generators, condensers and their accessories, such as Hyperbaric chambers
    • Penis enlargement devices
    • Pinhole eyewear that makes unapproved medical claims
    • Prescription eyewear
    • Polar Care Cold Therapy System products manufactured by BREG
    • Pulse oximeters. In order to be listed and sold by sellers outside of the Professional Health Care Program, pulse oximeters must be either (a) clearly labeled and consistently marketed as “for sports or aviation use only” or “not for medical use”, or (b) cleared by the FDA for OTC purchase and marketed accordingly
    • Radiesse
    • Resin tooth bonding agents, such as seizure bite sticks
    • Skin glue
    • Surgical kits
    • Surgical sutures
    • Ultra sound therapy and ultra sound pain relief devices
    • Vaginal pessary devices
    • Ventilator machines
    • Ventros Immunodiagnostic, integrated, and chemistry systems