Tenn. Comp. R. & Regs. 1155-04-.17 - SALE OF OVER-THE-COUNTER AND OFF-THE-SHELF DEVICES
(1) "Over-the-counter device" means a
prefabricated, mass-produced device that is prepackaged and requires no
professional advice or judgment in either size selection or use, including
fabric or elastic supports, corsets, generic arch supports and elastic
hoses.
(2) "Off-the-shelf device"
means a prefabricated prosthesis or orthosis sized or modified for use by the
patient in accordance with a prescription from a health care practitioner
authorized by law to write such prescriptions and which does not require
substantial clinical judgment and substantive alteration for appropriate
use.
(3) The sale of
over-the-counter and off-the-shelf devices by non-licensed persons is not
prohibited by these rules.
(4) No
person shall dispense or sell an over-the-counter device or an off-the-shelf
device based upon an image of the customer's limb captured by the person
through a mold, cast, scanning device, digital appliance, or pressure sensitive
device, unless the customer has first presented to that person a written
prescription for that device from a health care practitioner authorized by law
to write such a prescription.
Notes
Authority: T.C.A. ยงยง 4-5-202, 4-5-204, 63-3-106, 63-3-202, 63-3-203, and 63-3-205.
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