Regulatory Compliance

Following many years of effort and extensive work with the Regulators, the MedCenter fits within definitions for remote dispensing and telepharmacy technology in the Province of Ontario, and in the State of Illinois.

Elsewhere in the US, MedAvail has presented the MedCenter device and technology to Regulators in California, Texas, New Mexico, Florida, New Jersey, Kansas, Nevada and Arizona. Each of these Pharmacy Boards has indicated that the safety, security and reliability features of the MedCenter are sound. The Regulations in many of these States currently permit deployment of the MedCenter technology in certain specific settings (i.e. hospitals, long term care facilities, prisons, certain not for profit clinics, etc.) The following links point to some current regulations that govern the use of technologies such as the MedCenter:

  • California: California Business and Professions Code section 4119.1
    http://codes.findlaw.com/ca/business-and-professions-code/bpc-sect-4119-1.html
  • New Jersey: New Jersey Administrative Code 13:39 subchapter 10 page 105:
  • Florida: Florida Administrative Code 64B16-28.607 Automated Pharmacy System – Long Term Care, Hospice, Prison (note: click on “Florida Statutes and Administrative Codes” and go to “Title 64B16: Florida Administrative Code”)
    http://floridaspharmacy.gov/resources/
  • Nevada: Nevada Administrative Code 639.720 Mechanical Devices: Use to furnish drugs and medicines for administration to registered patients in medical facility and to patients receiving treatment in emergency room of hospital
  • North Dakota: North Dakota Practice Act Chapter 61-02-08 Tele-pharmacy Rules: (page 33)
    https://www.nodakpharmacy.com/pdfs/lawBook.pdf

MedAvail’s objective is to cause the applicable Regulations to be expanded over time such that the technology can be deployed in a wide variety of settings – including non-pharmacy retail environments, clinics and hospitals, employer sites, university campuses, etc.

The next steps for MedAvail in certain of these States are to conduct in-State pilots of the MedCenter based on a Waiver from existing Rules. Following successful Pilots, the Pharmacy Boards will be asked to write favorable rules and regulations (which they are empowered to do by their State Legislatures). MedAvail is working to receive Regulatory approvals and to cause permanent Rules to be implemented in multiple States concurrently.

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