Use of the MedCenter device and related technology is governed by State Pharmacy Law in each US State, provincial Pharmacy Laws in Canada, and in most other cases globally, by National Pharmacy or related Healthcare Laws (i.e. NHS in the United Kingdom).
Following many years of effort and extensive work with the Regulators, the MedCenter is approved remote dispensing and telepharmacy technology in the Province of Ontario, and in the State of Illinois.
- Ontario: Regulation 58/11 of the Drug and Pharmacies Act (see all references to “Automated Pharmacy System”): http://www.e-laws.gov.on.ca/html/regs/english/elaws_regs_110058_e.htm
- Illinois: Illinois Administrative Code Section 1330.510 Telepharmacy (see “Remote Automated Pharmacy System” or “RAPS”):
Elsewhere in the US, in 2013 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 current regulations where the MedCenter is approved for use:
- California: California Business and Professions Code section 4119.1: http://www.leginfo.ca.gov/cgi-bin/displaycode?section=bpc&group=04001-05000&file=4110-4126.5
- New Jersey: New Jersey Administrative Code 13:39 subchapter 10 page 105:
- Texas: Texas Administrative Code Chapter 291 Subchapter G Rule 291.121 (a)3(A):
- 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”):
- 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:
In several other US States, Regulations currently exist for telepharmacy and remote dispensing (the processes by which medicine can be dispensed to a patient without a Pharmacist being present), and as such approval of the MedCenter will require only minor adjustments to the current Regulatory framework. See the North Dakota regulations as one example:
- 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. MedAvail is planning to conduct such pilots in 2014 in several US States. 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 expects to receive Regulatory approvals and to cause permanent Rules to be implemented in these States by end of 2015.
In Europe, the MedCenter has been approved for use in the Netherlands by the Dutch Health Ministry – MedAvail is conducting a pilot in the Netherlands in early 2014.